Pharsight

1. List of Afinitor drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8778962	NOVARTIS	Treatment of solid tumors with rapamycin derivatives	Feb, 2022 (11 months ago)
US8436010	NOVARTIS	Treatment of solid tumors with rapamycin derivatives	Feb, 2022 (11 months ago)
US8778962 (Pediatric)	NOVARTIS	Treatment of solid tumors with rapamycin derivatives	Aug, 2022 (5 months ago)
US8436010 (Pediatric)	NOVARTIS	Treatment of solid tumors with rapamycin derivatives	Aug, 2022 (5 months ago)
US8410131	NOVARTIS	Cancer treatment	Nov, 2025 (2 years from now)
US8410131 (Pediatric)	NOVARTIS	Cancer treatment	May, 2026 (3 years from now)
US9006224	NOVARTIS	Neuroendocrine tumor treatment	Jul, 2028 (5 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Feb 26, 2023

Drugs and Companies using EVEROLIMUS ingredient

Market Authorisation Date: 30 March, 2009

Treatment: Treatment of patients with tuberous sclerosis complex (tsc) who have subependymal giant cell astrocytoma (sega) that requires therapeutic intervention but cannot be curatively resected.; Treatment of advanced hormone receptor positive, her2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; Treatment of solid excretory system tumors; Advanced renal cell carcinoma (rcc), after failure of treatment with sunitinib or sorafenib; Treatment of patients with progessive neuroendocrine tumors of pancreatic origin (pnet) that are unresectable, locally advanced or metastatic

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
10 mg	18 Jun, 2014	1		06 Dec, 2019	Extinguished
2.5 mg, 5 mg, and 7.5 mg	10 Dec, 2014	1	09 Dec, 2019	06 Dec, 2019	Extinguished

Strength	Dosage	Availability
2.5MG	TABLET;ORAL	Prescription
5MG	TABLET;ORAL	Prescription
7.5MG	TABLET;ORAL	Prescription
10MG	TABLET;ORAL	Prescription

2. List of Amturnide drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8183295	NOVARTIS	Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic	May, 2023 (3 months from now)

Drugs and Companies using ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE ingredient

Market Authorisation Date: 21 December, 2010

Treatment: NA

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 150MG BASE;EQ 5MG BASE;12.5MG	TABLET;ORAL	Discontinued
EQ 300MG BASE;EQ 5MG BASE;12.5MG	TABLET;ORAL	Discontinued
EQ 300MG BASE;EQ 5MG BASE;25MG	TABLET;ORAL	Discontinued
EQ 300MG BASE;EQ 10MG BASE;12.5MG	TABLET;ORAL	Discontinued
EQ 300MG BASE;EQ 10MG BASE;25MG	TABLET;ORAL	Discontinued

3. List of Arcapta Neohaler drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US6878721	NOVARTIS	Beta2-adrenoceptor agonists	Feb, 2025 (2 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8479730	NOVARTIS	Inhaler device	Oct, 2028 (5 years from now)

Drugs and Companies using INDACATEROL MALEATE ingredient

Market Authorisation Date: 01 July, 2011

Treatment: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema

Dosage: POWDER;INHALATION

Strength	Dosage	Availability
EQ 75MCG BASE	POWDER;INHALATION	Discontinued

4. List of Ciprodex drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9402805	NOVARTIS	Method of treating middle ear infections	Sep, 2022 (4 months ago)
US9149486	NOVARTIS	Method of treating middle ear infections	Sep, 2022 (4 months ago)
US9345714	NOVARTIS	Method of treating middle ear infections	Sep, 2022 (4 months ago)
US8846650	NOVARTIS	Method of treating middle ear infections	Jun, 2025 (2 years from now)

Drugs and Companies using CIPROFLOXACIN; DEXAMETHASONE ingredient

Market Authorisation Date: 18 July, 2003

Treatment: Treatment of acute otitis media; Treatment of acute otitis externa

Dosage: SUSPENSION/DROPS;OTIC

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.3%/0.1%	31 Jul, 2012	1		10 Aug, 2020	Extinguished

Strength	Dosage	Availability
0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription

5. List of Exforge Hct drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8101599	NOVARTIS	Pharmaceutical composition containing anti-hypertensive agents	May, 2023 (3 months from now)
US8475839	NOVARTIS	Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same	May, 2023 (3 months from now)
US8475839 (Pediatric)	NOVARTIS	Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same	Nov, 2023 (9 months from now)

Drugs and Companies using AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN ingredient

Market Authorisation Date: 30 April, 2009

Treatment: NA

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg	14 Sep, 2009	1	25 Sep, 2012	18 Jul, 2017	Eligible
10 mg/12.5 mg/ 160 mg	22 Oct, 2009	1	25 Sep, 2012	18 Jul, 2017	Eligible

Strength	Dosage	Availability
EQ 5MG BASE;12.5MG;160MG	TABLET;ORAL	Prescription
EQ 5MG BASE;25MG;160MG	TABLET;ORAL	Prescription
EQ 10MG BASE;12.5MG;160MG	TABLET;ORAL	Prescription
EQ 10MG BASE;25MG;160MG	TABLET;ORAL	Prescription
EQ 10MG BASE;25MG;320MG	TABLET;ORAL	Prescription

6. List of Gilenya drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8324283	NOVARTIS	Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol	Mar, 2026 (3 years from now)
US8324283 (Pediatric)	NOVARTIS	Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol	Sep, 2026 (3 years from now)
US9187405	NOVARTIS	S1P receptor modulators for treating relasping-remitting multiple sclerosis	Jun, 2027 (4 years from now)
US10543179	NOVARTIS	Dosage regimen of an S1P receptor modulator	Dec, 2027 (4 years from now)
US9187405 (Pediatric)	NOVARTIS	S1P receptor modulators for treating relasping-remitting multiple sclerosis	Dec, 2027 (4 years from now)
US9592208	NOVARTIS	Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol	Mar, 2032 (9 years from now)
US9592208 (Pediatric)	NOVARTIS	Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol	Sep, 2032 (9 years from now)

Drugs and Companies using FINGOLIMOD HYDROCHLORIDE ingredient

Market Authorisation Date: 21 September, 2010

Treatment: Treatment of relapsing-remitting sclerosis (ms); Treatment of relapsing remitting multiple sclerosis by determining varicella zoster virus (vzv) status and vaccinating prior to commencing treatment; Treatment of multiple sclerosis in the pediatric patient population with 0.25 mg fingolimod

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.5 mg	22 Sep, 2014	19	04 Dec, 2019	29 Mar, 2026	Deferred
0.25 mg	19 Jul, 2018	1	12 Nov, 2021	30 Mar, 2032	Eligible

Strength	Dosage	Availability
EQ 0.25MG BASE	CAPSULE;ORAL	Prescription
EQ 0.5MG BASE	CAPSULE;ORAL	Prescription

7. List of Gleevec drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6958335 (Pediatric)	NOVARTIS	Treatment of gastrointestinal stromal tumors	Jun, 2022 (7 months ago)

Drugs and Companies using IMATINIB MESYLATE ingredient

Market Authorisation Date: 18 April, 2003

Treatment: NA

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg and 400 mg	12 Mar, 2007	1	03 Dec, 2015	23 Nov, 2019	Non-forfeiture

Strength	Dosage	Availability
EQ 100MG BASE	TABLET;ORAL	Prescription
EQ 400MG BASE	TABLET;ORAL	Prescription

8. List of Hycamtin drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8158645	NOVARTIS	Compound, corresponding compositions, preparation and/or treatment methods	Dec, 2024 (1 year, 10 months from now)

Drugs and Companies using TOPOTECAN HYDROCHLORIDE ingredient

Market Authorisation Date: 11 October, 2007

Treatment: NA

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
EQ 0.25MG BASE	CAPSULE;ORAL	Prescription
EQ 1MG BASE	CAPSULE;ORAL	Prescription

9. List of Ilevro drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7947295	NOVARTIS	Ophthalmic compositions containing a synergistic combination of two polymers	Jun, 2024 (1 year, 4 months from now)
US9662398	NOVARTIS	Carboxylvinyl polymer-containing nanoparticle suspensions	Dec, 2030 (7 years from now)
US8921337	NOVARTIS	Carboxyvinyl polymer-containing nanoparticle suspensions	Mar, 2032 (9 years from now)

Drugs and Companies using NEPAFENAC ingredient

Market Authorisation Date: 16 October, 2012

Treatment: NA

Dosage: SUSPENSION/DROPS;OPHTHALMIC

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.003	21 Dec, 2015	1		31 Mar, 2032

Strength	Dosage	Availability
0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription

10. List of Izba drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9144561	NOVARTIS	Pharmaceutical compositions having desirable bioavailability	Mar, 2029 (6 years from now)
US8754123	NOVARTIS	Pharmaceutical compositions having desirable bioavailability	May, 2029 (6 years from now)
US8722735	NOVARTIS	Pharmaceutical compositions having desirable bioavailability	Oct, 2029 (6 years from now)
US8178582	NOVARTIS	Pharmaceutical compositions having desirable bioavailability	Oct, 2029 (6 years from now)

Drugs and Companies using TRAVOPROST ingredient

Market Authorisation Date: 15 May, 2014

Treatment: NA

Dosage: SOLUTION/DROPS;OPHTHALMIC

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.00003	30 Dec, 2015	1		10 Oct, 2029	Extinguished

Strength	Dosage	Availability
0.003%	SOLUTION/DROPS;OPHTHALMIC	Discontinued

11. List of Kisqali drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8324225	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Jun, 2028 (5 years from now)
US8685980	NOVARTIS	Pyrrolopyrimidine compounds and their uses	May, 2030 (7 years from now)
US8415355	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Mar, 2031 (8 years from now)
US9193732	NOVARTIS	Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-D]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof	Nov, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9416136	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Aug, 2029 (6 years from now)
US8962630	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Dec, 2029 (6 years from now)
US9868739	NOVARTIS	Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof	Nov, 2031 (8 years from now)
US10799506	NOVARTIS	Ribociclib tablet	Apr, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Mar 13, 2022
New Patient Population (NPP)	Dec 10, 2024

Drugs and Companies using RIBOCICLIB SUCCINATE ingredient

NCE-1 date: March, 2021

Market Authorisation Date: 13 March, 2017

Treatment: In combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; In combination with fulvestrant for the treatment of postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy; In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her-2)-negative advanced or metastatic breast cancer; In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of hr-positive, her2-negative advanced or metastatic breast cancer; In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
200 mg	15 Mar, 2021	4		14 Apr, 2036

Strength	Dosage	Availability
EQ 200MG BASE	TABLET;ORAL	Prescription

12. List of Kisqali Femara Co-pack (copackaged) drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8324225	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Jun, 2028 (5 years from now)
US8685980	NOVARTIS	Pyrrolopyrimidine compounds and their uses	May, 2030 (7 years from now)
US8415355	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Mar, 2031 (8 years from now)
US9193732	NOVARTIS	Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-D]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof	Nov, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9416136	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Aug, 2029 (6 years from now)
US8962630	NOVARTIS	Pyrrolopyrimidine compounds and their uses	Dec, 2029 (6 years from now)
US9868739	NOVARTIS	Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof	Nov, 2031 (8 years from now)
US10799506	NOVARTIS	Ribociclib tablet	Apr, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Mar 13, 2022
New Patient Population (NPP)	Dec 10, 2024

Drugs and Companies using LETROZOLE; RIBOCICLIB SUCCINATE ingredient

NCE-1 date: March, 2021

Market Authorisation Date: 04 May, 2017

Treatment: Treatment of pre/perimenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer; As initial endocrine-based therapy for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
200 mg and 2.5 mg	15 Mar, 2021	4		14 Apr, 2036

Strength	Dosage	Availability
2.5MG;EQ 200MG BASE	TABLET;ORAL	Prescription

13. List of Leqvio drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9074213	NOVARTIS	Compositions and methods for inhibiting expression of a target gene	Mar, 2022 (10 months ago)
US8546143	NOVARTIS	Compositions and methods for inhibiting expression of a target gene	Apr, 2022 (9 months ago)
US8232383	NOVARTIS	RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA)	Feb, 2023 (21 days from now)
US11078485	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Nov, 2023 (9 months from now)
US9708610	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Jan, 2024 (11 months from now)
US10273477	NOVARTIS	Therapeutic compositions	Mar, 2024 (1 year, 1 month from now)
US10669544	NOVARTIS	Therapeutic compositions	Mar, 2024 (1 year, 1 month from now)
US9708615	NOVARTIS	Therapeutic compositions	Mar, 2024 (1 year, 1 month from now)
US8809292	NOVARTIS	Compositions and methods for inhibiting expression of the PCSK9 gene	May, 2027 (4 years from now)
US10131907	NOVARTIS	Glycoconjugates of RNA interference agents	Aug, 2028 (5 years from now)
US9370582	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US10806791	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US8828956	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US8106022	NOVARTIS	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2029 (6 years from now)
US10125369	NOVARTIS	PCSK9 iRNA compositions and methods of use thereof	Aug, 2034 (11 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10590418	NOVARTIS	Methods and compositions for RNAi mediated inhibition of gene expression in mammals	Jul, 2022 (6 months ago)
US10266825	NOVARTIS	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Nov, 2023 (9 months from now)
US8222222	NOVARTIS	Compositions and methods for inhibiting expression of the PCSK9 gene	Dec, 2027 (4 years from now)
US10851377	NOVARTIS	Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder	Aug, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Dec 22, 2026

Drugs and Companies using INCLISIRAN SODIUM ingredient

NCE-1 date: December, 2025

Market Authorisation Date: 22 December, 2021

Treatment: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (hefh) or clinical atherosclerotic cardiovascular disease (ascvd), by inhibiting expression of the pcsk9 gene

Dosage: SOLUTION;SUBCUTANEOUS

Strength	Dosage	Availability
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION;SUBCUTANEOUS	Prescription

14. List of Mayzent drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7939519	NOVARTIS	Immunosuppresant compounds and compositions	Aug, 2028 (5 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8492441	NOVARTIS	Dosage regimen of an S1P receptor agonist	Nov, 2030 (7 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Mar 26, 2024
M	Mar 1, 2025

Drugs and Companies using SIPONIMOD FUMARIC ACID ingredient

NCE-1 date: March, 2023

Market Authorisation Date: 26 March, 2019

Treatment: A method of treating multiple sclerosis by administering siponimod using a titration scheme to reach a maintenance dose

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 0.25MG BASE	TABLET;ORAL	Prescription
EQ 1MG BASE	TABLET;ORAL	Prescription
EQ 2MG BASE	TABLET;ORAL	Prescription

15. List of Mekinist drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7378423	NOVARTIS	Pyrimidine compound and medical use thereof	May, 2027 (4 years from now)
US8703781	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors	Oct, 2030 (7 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8835443	NOVARTIS	Pyrimidine compound and medical use thereof	Jun, 2025 (2 years from now)
US8952018	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors	Oct, 2030 (7 years from now)
US9399021	NOVARTIS	Pharmaceutical composition	Jan, 2032 (9 years from now)
US9271941	NOVARTIS	Pharmaceutical composition	Jan, 2032 (9 years from now)
US9155706	NOVARTIS	Pharmaceutical composition	Jan, 2032 (9 years from now)
US8580304	NOVARTIS	Pharmaceutical composition	Jan, 2032 (9 years from now)
US10869869	NOVARTIS	Method of adjuvant cancer treatment	Aug, 2033 (10 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Jun 22, 2024
M	Oct 6, 2022
New Indication (I)	Jun 22, 2025

Drugs and Companies using TRAMETINIB DIMETHYL SULFOXIDE ingredient

Market Authorisation Date: 29 May, 2013

Treatment: Mekinist is indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test; Treatment of unresectable or metastatic melanoma; Mekinist is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test; In combination with dabrafenib for the treatment of unresectable or metastatic melanoma.; Mekinist is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment options; Mekinist is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection; Mekinist(r) is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations as detected by an fda-approved test, and involvement of lymph node(s), following complete resection; Mekinist in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 0.5MG	TABLET;ORAL	Prescription
EQ 1MG	TABLET;ORAL	Discontinued
EQ 2MG	TABLET;ORAL	Prescription

16. List of Moxeza drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9114168	NOVARTIS	Pharmaceutical compositions containing a fluoroquinolone antibiotic drug	May, 2029 (6 years from now)
US8450311	NOVARTIS	Pharmaceutical compositions containing a fluoroquinolone antibiotic drug	May, 2029 (6 years from now)

Drugs and Companies using MOXIFLOXACIN HYDROCHLORIDE ingredient

Market Authorisation Date: 19 November, 2010

Treatment: NA

Dosage: SOLUTION/DROPS;OPHTHALMIC

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.005	29 Feb, 2012	1	28 May, 2015	20 Sep, 2019	Eligible

Strength	Dosage	Availability
EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription

17. List of Nevanac drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8071648	NOVARTIS	Topical nepafenac formulations	Dec, 2025 (2 years from now)
US8324281	NOVARTIS	Topical nepafenac formulations	Dec, 2025 (2 years from now)
US7834059	NOVARTIS	Topical nepafenac formulations	Jan, 2027 (4 years from now)

Drugs and Companies using NEPAFENAC ingredient

Market Authorisation Date: 19 August, 2005

Treatment: Method of treating ocular inflammation

Dosage: SUSPENSION/DROPS;OPHTHALMIC

Strength	Dosage	Availability
0.1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription

18. List of Patanase drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8399508	NOVARTIS	Olopatadine formulations for topical nasal administration	Sep, 2022 (4 months ago)
US7977376	NOVARTIS	Olopatadine formulations for topical nasal administration	Feb, 2023 (3 days from now)
US8399508 (Pediatric)	NOVARTIS	Olopatadine formulations for topical nasal administration	Mar, 2023 (a month from now)
US7977376 (Pediatric)	NOVARTIS	Olopatadine formulations for topical nasal administration	Aug, 2023 (6 months from now)

Drugs and Companies using OLOPATADINE HYDROCHLORIDE ingredient

Market Authorisation Date: 15 April, 2008

Treatment: Allergic rhinitis

Dosage: SPRAY, METERED;NASAL

19. List of Piqray drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8476268	NOVARTIS	Pyrrolidine-1,2-dicarboxamide derivatives	Sep, 2029 (6 years from now)
US8227462	NOVARTIS	Pyrrolidine-1,2-dicarboxamide derivatives	Sep, 2030 (7 years from now)
CN102149711B	NOVARTIS	Organic Compounds	Sep, 2029 (6 years from now)
CN102149711A	NOVARTIS	Organic Compounds	Sep, 2029 (6 years from now)
IN307469B	NOVARTIS	The Compound (S)-Pyrrolidine-1,2-Dicarboxylic Acid 2-Amide-1- ({4-Methyl-5-[2-(2,2,2-Trifluoro-1,1-Dimethyl-Ethyl)- Pyridin-4-Yl]-Thiazol-2-Yl}-Amide)	Sep, 2029 (6 years from now)
EP2331537A1	NOVARTIS	1-((5-Heteroarylthiazol-2-Yl)Aminocarbonyl)Pyrrolidine-2-Carboxamide Derivatives As Phosphatidylinositol 3-Kinase (Pi3K) Inhibitors Useful In The Treatment Of Proliferative Diseases	Sep, 2029 (6 years from now)
EP2331537B1	NOVARTIS	1-((5-Heteroarylthiazol-2-Yl)Aminocarbonyl)Pyrrolidine-2-Carboxamide Derivatives As Phosphatidylinositol 3-Kinase (Pi3K) Inhibitors Useful In The Treatment Of Proliferative Diseases	Sep, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	May 24, 2024

Drugs and Companies using ALPELISIB ingredient

NCE-1 date: May, 2023

Market Authorisation Date: 24 May, 2019

Treatment: In combination with fulvestrant for treatment of postmenopausal women, and men, with hr-positive, her-2-negative, pik3ca-mutated, advanced or metastatic breast cancer

Dosage: TABLET;ORAL

20. List of Promacta drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7160870	NOVARTIS	Thrombopoietin mimetics	Nov, 2022 (2 months ago)
US7547719	NOVARTIS	3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine)	Jul, 2025 (2 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7160870 (Pediatric)	NOVARTIS	Thrombopoietin mimetics	May, 2023 (3 months from now)
US7795293	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	May, 2023 (3 months from now)
US7795293 (Pediatric)	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Nov, 2023 (9 months from now)
US7547719 (Pediatric)	NOVARTIS	3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine)	Jan, 2026 (2 years from now)
US8052994	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene] hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Aug, 2027 (4 years from now)
US8071129	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Aug, 2027 (4 years from now)
US8052993	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Aug, 2027 (4 years from now)
US8828430	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Aug, 2027 (4 years from now)
US8062665	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Aug, 2027 (4 years from now)
US8052994 (Pediatric)	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene] hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Feb, 2028 (5 years from now)
US8828430 (Pediatric)	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Feb, 2028 (5 years from now)
US8071129 (Pediatric)	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Feb, 2028 (5 years from now)
US8062665 (Pediatric)	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Feb, 2028 (5 years from now)
US8052993 (Pediatric)	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Feb, 2028 (5 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Nov 16, 2025
Pediatric Exclusivity (PED)	Feb 26, 2022

Drugs and Companies using ELTROMBOPAG OLAMINE ingredient

Market Authorisation Date: 20 November, 2008

Treatment: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy; Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp); Treatment of thrombocytopenia in patients with chronic hepatitis c to allow the initiation and maintenance of interferon-based therapy; Treatment of idiopathic thrombocytopenic purpura (itp); Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (itp); Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia

Dosage: TABLET;ORAL

21. List of Promacta Kit drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7160870	NOVARTIS	Thrombopoietin mimetics	Nov, 2022 (2 months ago)
US7547719	NOVARTIS	3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine)	Jul, 2025 (2 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7160870 (Pediatric)	NOVARTIS	Thrombopoietin mimetics	May, 2023 (3 months from now)
US7795293	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	May, 2023 (3 months from now)
US7795293 (Pediatric)	NOVARTIS	3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)	Nov, 2023 (9 months from now)
US7547719 (Pediatric)	NOVARTIS	3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine)	Jan, 2026 (2 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Nov 16, 2025
Pediatric Exclusivity (PED)	Feb 26, 2022

Drugs and Companies using ELTROMBOPAG OLAMINE ingredient

Market Authorisation Date: 24 August, 2015

Treatment: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp); Treatment of thrombocytopenia in patients with chronic hepatitis c to allow the initiation and maintenance of interferon-based therapy; Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy; Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia

Dosage: FOR SUSPENSION;ORAL

22. List of Reclast drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8052987	NOVARTIS	Method of administering bisphosphonates	Oct, 2023 (8 months from now)
US7932241	NOVARTIS	Pharmaceutical products comprising bisphosphonates	Feb, 2028 (5 years from now)
US7932241 (Pediatric)	NOVARTIS	Pharmaceutical products comprising bisphosphonates	Aug, 2028 (5 years from now)

Drugs and Companies using ZOLEDRONIC ACID ingredient

Market Authorisation Date: 16 April, 2007

Treatment: Treatment and prevention of postmenopausal or glucocorticoid-induced osteoporosis and treatment to increase bone mass in men with osteoporosis

Dosage: INJECTABLE;INTRAVENOUS

23. List of Rydapt drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8222244	NOVARTIS	Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity	Oct, 2022 (3 months ago)
US7973031	NOVARTIS	Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity	Oct, 2028 (5 years from now)
US8575146	NOVARTIS	Pharmaceutical uses of staurosporine derivatives	Dec, 2030 (7 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Apr 28, 2022
Orphan Drug Exclusivity (ODE)	Apr 28, 2024

Drugs and Companies using MIDOSTAURIN ingredient

NCE-1 date: April, 2021

Market Authorisation Date: 28 April, 2017

Treatment: Treatment of adult patients with newly diagnosed acute myeloid leukemia (aml) who are flt3 mutation-positive, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy; Treatment of adult patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with associated hematological neoplasm (sm-ahn), or mast cell leukemia (mcl)

Dosage: CAPSULE;ORAL

24. List of Scemblix drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8829195	NOVARTIS	Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1	May, 2033 (10 years from now)
US11407735	NOVARTIS	Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide	May, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Oct 29, 2026
Orphan Drug Exclusivity (ODE)	Oct 29, 2028

Drugs and Companies using ASCIMINIB HYDROCHLORIDE ingredient

NCE-1 date: October, 2025

Market Authorisation Date: 29 October, 2021

Treatment: Treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml)

Dosage: TABLET;ORAL

25. List of Seebri drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8479730	NOVARTIS	Inhaler device	Oct, 2028 (5 years from now)
US8182838	NOVARTIS	Dry powder composition comprising co-jet milled particles for pulmonary inhalation	Oct, 2028 (5 years from now)

Drugs and Companies using GLYCOPYRROLATE ingredient

Market Authorisation Date: 29 October, 2015

Treatment: NA

Dosage: POWDER;INHALATION

26. List of Tafinlar drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8415345	NOVARTIS	Benzene sulfonamide thiazole and oxazole compounds	Jan, 2030 (6 years from now)
US7994185	NOVARTIS	Benzene sulfonamide thiazole and oxazole compounds	Jan, 2030 (6 years from now)
US8703781	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors	Oct, 2030 (7 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8835443	NOVARTIS	Pyrimidine compound and medical use thereof	Jun, 2025 (2 years from now)
US9233956	NOVARTIS	Benzene sulfonamide thiazole and oxazole compounds	May, 2029 (6 years from now)
US8952018	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors	Oct, 2030 (7 years from now)
US10869869	NOVARTIS	Method of adjuvant cancer treatment	Aug, 2033 (10 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Jun 22, 2024
M	Oct 6, 2022
New Indication (I)	Jun 22, 2025

Drugs and Companies using DABRAFENIB MESYLATE ingredient

Market Authorisation Date: 29 May, 2013

Treatment: Tafinlar(r) is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test.; Tafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment options; Tafinlar(r) is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test.; Tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection; Tafinlar is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test.; Treatment of patients with unresectable or metastatic melanoma with braf v600e mutations after confirming the presence of braf v600e mutation; Tafinlar is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fda-approved test; Tafinlar(r) is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations as detected by an fda-approved test, and involvement of lymph node(s), following complete resection; Treatment of melanoma; Tafinlar in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma

Dosage: CAPSULE;ORAL

27. List of Tasigna drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7169791	NOVARTIS	Inhibitors of tyrosine kinases	Jul, 2023 (5 months from now)
US8415363	NOVARTIS	Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide	Jul, 2026 (3 years from now)
US8163904	NOVARTIS	Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide	Aug, 2028 (5 years from now)
US9061029	NOVARTIS	Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity	Apr, 2032 (9 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7169791 (Pediatric)	NOVARTIS	Inhibitors of tyrosine kinases	Jan, 2024 (11 months from now)
US8501760	NOVARTIS	Pharmaceutical compositions comprising nilotinib or its salt	Jul, 2026 (3 years from now)
US8389537	NOVARTIS	Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide	Jul, 2026 (3 years from now)
US8415363 (Pediatric)	NOVARTIS	Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide	Jan, 2027 (3 years from now)
US8389537 (Pediatric)	NOVARTIS	Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide	Jan, 2027 (3 years from now)
US8501760 (Pediatric)	NOVARTIS	Pharmaceutical compositions comprising nilotinib or its salt	Jan, 2027 (3 years from now)
US8293756	NOVARTIS	Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate	Sep, 2027 (4 years from now)
US8293756 (Pediatric)	NOVARTIS	Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate	Mar, 2028 (5 years from now)
US8163904 (Pediatric)	NOVARTIS	Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide	Feb, 2029 (6 years from now)
US9061029 (Pediatric)	NOVARTIS	Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity	Oct, 2032 (9 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Sep 23, 2028
Pediatric Exclusivity (PED)	Sep 22, 2025

Drugs and Companies using NILOTINIB HYDROCHLORIDE ingredient

Market Authorisation Date: 29 October, 2007

Treatment: Treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml); A method for the treatment of leukemias; Treatment of newly diagnosed philadelphia chromosome positive chronic myeloid leukemia (ph + cml); Treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml) by administering nilotinib dispersed in a fruit preparation

Dosage: CAPSULE;ORAL

28. List of Tekamlo drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8613949	NOVARTIS	Galenical formulations of organic compounds	Dec, 2029 (6 years from now)

Drugs and Companies using ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE ingredient

Market Authorisation Date: 26 August, 2010

Treatment: NA

Dosage: TABLET;ORAL

29. List of Travatan Z drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8323630	NOVARTIS	Self-preserved aqueous pharmaceutical compositions	Sep, 2027 (4 years from now)
US8388941	NOVARTIS	Self preserved aqueous pharmaceutical compositions	Sep, 2027 (4 years from now)
US8268299	NOVARTIS	Self preserved aqueous pharmaceutical compositions	Oct, 2029 (6 years from now)

Drugs and Companies using TRAVOPROST ingredient

Market Authorisation Date: 21 September, 2006

Treatment: NA

Dosage: SOLUTION/DROPS;OPHTHALMIC

30. List of Triesence drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8211880	NOVARTIS	Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection	Mar, 2029 (6 years from now)
US8128960	NOVARTIS	Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection	Dec, 2029 (6 years from now)

Drugs and Companies using TRIAMCINOLONE ACETONIDE ingredient

Market Authorisation Date: 29 November, 2007

Treatment: Visualization during vitrectomy procedures; Treatment of ophthalmic disorders

Dosage: INJECTABLE;INTRAVITREAL

31. List of Tykerb drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8821927	NOVARTIS	Pharmaceutical composition	Sep, 2029 (6 years from now)

Drugs and Companies using LAPATINIB DITOSYLATE ingredient

Market Authorisation Date: 13 March, 2007

Treatment: NA

Dosage: TABLET;ORAL

32. List of Tyzeka drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7589079	NOVARTIS	Crystalline and amorphous forms of beta-L-2′-deoxythymidine	Sep, 2023 (7 months from now)
US7858594	NOVARTIS	Crystalline and amorphous forms of beta-L-2′-deoxythymidine	Sep, 2023 (7 months from now)

Drugs and Companies using TELBIVUDINE ingredient

Market Authorisation Date: 25 October, 2006

Treatment: Treatment of chronic hepatitis b in adult patients

Dosage: TABLET;ORAL

33. List of Utibron drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US6878721	NOVARTIS	Beta2-adrenoceptor agonists	Feb, 2025 (2 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8479730	NOVARTIS	Inhaler device	Oct, 2028 (5 years from now)
US8182838	NOVARTIS	Dry powder composition comprising co-jet milled particles for pulmonary inhalation	Oct, 2028 (5 years from now)

Drugs and Companies using GLYCOPYRROLATE; INDACATEROL MALEATE ingredient

Market Authorisation Date: 29 October, 2015

Treatment: Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd)

Dosage: POWDER;INHALATION

34. List of Valturna drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8168616	NOVARTIS	Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension	Jul, 2026 (3 years from now)

Drugs and Companies using ALISKIREN HEMIFUMARATE; VALSARTAN ingredient

Market Authorisation Date: 16 September, 2009

Treatment: NA

Dosage: TABLET;ORAL

35. List of Vijoice drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8476268	NOVARTIS	Pyrrolidine-1,2-dicarboxamide derivatives	Sep, 2029 (6 years from now)
US8227462	NOVARTIS	Pyrrolidine-1,2-dicarboxamide derivatives	Sep, 2030 (7 years from now)
CN102149711B	NOVARTIS	Organic Compounds	Sep, 2029 (6 years from now)
CN102149711A	NOVARTIS	Organic Compounds	Sep, 2029 (6 years from now)
IN307469B	NOVARTIS	The Compound (S)-Pyrrolidine-1,2-Dicarboxylic Acid 2-Amide-1- ({4-Methyl-5-[2-(2,2,2-Trifluoro-1,1-Dimethyl-Ethyl)- Pyridin-4-Yl]-Thiazol-2-Yl}-Amide)	Sep, 2029 (6 years from now)
EP2331537A1	NOVARTIS	1-((5-Heteroarylthiazol-2-Yl)Aminocarbonyl)Pyrrolidine-2-Carboxamide Derivatives As Phosphatidylinositol 3-Kinase (Pi3K) Inhibitors Useful In The Treatment Of Proliferative Diseases	Sep, 2029 (6 years from now)
EP2331537B1	NOVARTIS	1-((5-Heteroarylthiazol-2-Yl)Aminocarbonyl)Pyrrolidine-2-Carboxamide Derivatives As Phosphatidylinositol 3-Kinase (Pi3K) Inhibitors Useful In The Treatment Of Proliferative Diseases	Sep, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	May 24, 2024

Drugs and Companies using ALPELISIB ingredient

NCE-1 date: May, 2023

Market Authorisation Date: 05 April, 2022

Treatment: NA

Dosage: TABLET;ORAL

36. List of Votrient drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7105530	NOVARTIS	Pyrimidineamines as angiogenesis modulators	Oct, 2023 (8 months from now)

Drugs and Companies using PAZOPANIB HYDROCHLORIDE ingredient

Market Authorisation Date: 19 October, 2009

Treatment: NA

Dosage: TABLET;ORAL

37. List of Xiidra drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7745460	NOVARTIS	Modulators of cellular adhesion	Nov, 2024 (1 year, 9 months from now)
US7928122	NOVARTIS	Modulators of cellular adhesion	Nov, 2024 (1 year, 9 months from now)
US7314938	NOVARTIS	Modulators of cellular adhesion	Mar, 2025 (2 years from now)
US8084047	NOVARTIS	Compositions and methods for treatment of eye disorders	May, 2026 (3 years from now)
US9890141	NOVARTIS	Crystalline pharmaceutical and methods of preparation and use thereof	Oct, 2030 (7 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9216174	NOVARTIS	Modulators of cellular adhesion	Nov, 2024 (1 year, 9 months from now)
US10124000	NOVARTIS	Modulators of cellular adhesion	Nov, 2024 (1 year, 9 months from now)
US7790743	NOVARTIS	Modulators of cellular adhesion	Nov, 2024 (1 year, 9 months from now)
US8592450	NOVARTIS	Compositions and methods for treatment of eye disorders	May, 2026 (3 years from now)
US8367701	NOVARTIS	Crystalline pharmaceutical and methods of preparation and use thereof	Apr, 2029 (6 years from now)
US9447077	NOVARTIS	Crystalline pharmaceutical and methods of preparation and use thereof	Apr, 2029 (6 years from now)
US8168655	NOVARTIS	Compositions and methods for treatment of eye disorders	May, 2029 (6 years from now)
US9353088	NOVARTIS	Crystalline pharmaceutical and methods of preparation and use thereof	Oct, 2030 (7 years from now)
US8927574	NOVARTIS	Crystalline pharmaceutical and methods of preparation and use thereof	Nov, 2030 (7 years from now)
US9085553	NOVARTIS	LFA-1 inhibitor and methods of preparation and polymorph thereof	Jul, 2033 (10 years from now)
US11058677	NOVARTIS	LFA-1 inhibitor formulations	Dec, 2033 (10 years from now)

Drugs and Companies using LIFITEGRAST ingredient

Market Authorisation Date: 11 July, 2016

Treatment: Treatment of the signs and symptoms of dry eye disease (ded); Treatment of signs and symptoms of dry eye disease (ded)

Dosage: SOLUTION/DROPS;OPHTHALMIC

38. List of Zometa drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8324189	NOVARTIS	Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases	May, 2025 (2 years from now)
US8324189 (Pediatric)	NOVARTIS	Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases	Nov, 2025 (2 years from now)
US7932241	NOVARTIS	Pharmaceutical products comprising bisphosphonates	Feb, 2028 (5 years from now)

Drugs and Companies using ZOLEDRONIC ACID ingredient

Market Authorisation Date: 20 August, 2001

Treatment: Multiple myeloma; Bone metastases; Hypercalcemia of malignancy

Dosage: INJECTABLE;INTRAVENOUS

39. List of Zykadia drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8188276	NOVARTIS	2,4-pyrimidinediamine compounds and their uses	Jan, 2023 (a day from now)
US8835430	NOVARTIS	2,4-pyrimidinediamine compounds and their uses	Jan, 2023 (a day from now)
US9018204	NOVARTIS	2,4-pyrimidinediamine compounds and their uses	Jan, 2023 (a day from now)
US9416112	NOVARTIS	2,4-pyrimidinediamine compounds and their uses	Jan, 2023 (a day from now)
US7893074	NOVARTIS	2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders	Apr, 2026 (3 years from now)
US8399450	NOVARTIS	Compounds and compositions as protein kinase inhibitors	Nov, 2027 (4 years from now)
US7964592	NOVARTIS	2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders	Apr, 2028 (5 years from now)
US8039479	NOVARTIS	Compounds and compositions as protein kinase inhibitors	Jun, 2030 (7 years from now)
US9309229	NOVARTIS	Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propane-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine	Jan, 2032 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8377921	NOVARTIS	Compounds and compositions as protein kinase inhibitors	Nov, 2027 (4 years from now)
US8703787	NOVARTIS	Methods of using ALK inhibitors	Feb, 2032 (9 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	May 26, 2024

Drugs and Companies using CERITINIB ingredient

Market Authorisation Date: 29 April, 2014

Treatment: Treatment of a cancer mediated by an anaplastic lymphoma kinase (alk)

Dosage: CAPSULE;ORAL

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Drugs made by Novartis Pharm

Drugs expiring in 2023

Strength	Dosage	Availability
50MG	TABLET;ORAL	Prescription
150MG	TABLET;ORAL	Prescription
200MG	TABLET;ORAL	Prescription

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg and 75 mg	07 Jan, 2014	1		01 Feb, 2028
12.5 mg and 25 mg	04 Feb, 2014	1		01 Feb, 2028

Strength	Dosage	Availability
EQ 12.5MG ACID	TABLET;ORAL	Prescription
EQ 25MG ACID	TABLET;ORAL	Prescription
EQ 50MG ACID	TABLET;ORAL	Prescription
EQ 75MG ACID	TABLET;ORAL	Prescription
EQ 100MG ACID	TABLET;ORAL	Discontinued

Strength	Dosage	Availability
EQ 12.5MG ACID/PACKET	FOR SUSPENSION;ORAL	Prescription
EQ 25MG ACID/PACKET	FOR SUSPENSION;ORAL	Prescription

Strength	Dosage	Availability
EQ 20MG BASE	TABLET;ORAL	Prescription
EQ 40MG BASE	TABLET;ORAL	Prescription

Strength	Dosage	Availability
EQ 50MG BASE	CAPSULE;ORAL	Prescription
EQ 75MG BASE	CAPSULE;ORAL	Prescription

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg	17 Oct, 2019	1		07 Apr, 2032
150 mg and 200 mg	08 Nov, 2013	1		18 Jul, 2026

Strength	Dosage	Availability
EQ 150MG BASE;EQ 5MG BASE	TABLET;ORAL	Discontinued
EQ 150MG BASE;EQ 10MG BASE	TABLET;ORAL	Discontinued
EQ 300MG BASE;EQ 5MG BASE	TABLET;ORAL	Discontinued
EQ 300MG BASE;EQ 10MG BASE	TABLET;ORAL	Discontinued

Strength	Dosage	Availability
EQ 150MG BASE;160MG	TABLET;ORAL	Discontinued
EQ 300MG BASE;320MG	TABLET;ORAL	Discontinued

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.8 mg (base) /mL	11 Jun, 2008	1		02 Sep, 2012	Extinguished
4 mg/100 mL, 100 mL vial	31 Jan, 2012	1		05 Feb, 2028	Extinguished

Strength	Dosage	Availability
EQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued
EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Prescription
EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription

Pharsight

Drug Patents owned by Novartis

1. List of Afinitor drug patents

2. List of Amturnide drug patents

3. List of Arcapta Neohaler drug patents

4. List of Ciprodex drug patents

5. List of Exforge Hct drug patents

6. List of Gilenya drug patents

7. List of Gleevec drug patents

8. List of Hycamtin drug patents

9. List of Ilevro drug patents

10. List of Izba drug patents

11. List of Kisqali drug patents

12. List of Kisqali Femara Co-pack (copackaged) drug patents

13. List of Leqvio drug patents

14. List of Mayzent drug patents

15. List of Mekinist drug patents

16. List of Moxeza drug patents

17. List of Nevanac drug patents

18. List of Patanase drug patents

19. List of Piqray drug patents

20. List of Promacta drug patents

21. List of Promacta Kit drug patents

22. List of Reclast drug patents

23. List of Rydapt drug patents

24. List of Scemblix drug patents

25. List of Seebri drug patents

26. List of Tafinlar drug patents

27. List of Tasigna drug patents

28. List of Tekamlo drug patents

29. List of Travatan Z drug patents

30. List of Triesence drug patents

31. List of Tykerb drug patents

32. List of Tyzeka drug patents

33. List of Utibron drug patents

34. List of Valturna drug patents

35. List of Vijoice drug patents

36. List of Votrient drug patents

37. List of Xiidra drug patents

38. List of Zometa drug patents

39. List of Zykadia drug patents

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