Pharsight

1. Absorica Ld patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9750711	SUN PHARM	Low dose oral pharmaceutical composition of isotretinoin	May, 2035 (11 years from now)
US9700535	SUN PHARM	Oral pharmaceutical composition of isotretinoin	Aug, 2035 (11 years from now)

Drugs and Companies using ISOTRETINOIN ingredient

Market Authorisation Date: 05 November, 2019

Treatment: NA

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
16MG	CAPSULE;ORAL	Prescription
24MG	CAPSULE;ORAL	Prescription
20MG	CAPSULE;ORAL	Discontinued
8MG	CAPSULE;ORAL	Prescription
32MG	CAPSULE;ORAL	Prescription
28MG	CAPSULE;ORAL	Discontinued

ABSORICA LD family patents

2. Bromsite patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8778999	SUN PHARM	Non-steroidal anti-inflammatory ophthalmic compositions	Aug, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Apr 08, 2019

Drugs and Companies using BROMFENAC SODIUM ingredient

Market Authorisation Date: 08 April, 2016

Treatment: Treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery

Dosage: SOLUTION/DROPS;OPHTHALMIC

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.00075	25 Oct, 2017	1		07 Aug, 2029

Strength	Dosage	Availability
EQ 0.075% ACID	SOLUTION/DROPS;OPHTHALMIC	Prescription

BROMSITE family patents

3. Bynfezia Pen patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10342850	SUN PHARM	Octreotide injection	May, 2038 (14 years from now)

Drugs and Companies using OCTREOTIDE ACETATE ingredient

Market Authorisation Date: 28 January, 2020

Treatment: NA

Dosage: SOLUTION;SUBCUTANEOUS

Strength	Dosage	Availability
EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION;SUBCUTANEOUS	Prescription

BYNFEZIA PEN family patents

4. Cequa patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9937225	SUN PHARM	Topical formulations and uses thereof	Aug, 2033 (9 years from now)
US10441630	SUN PHARM	Topical formulations and uses thereof	Aug, 2033 (9 years from now)
US8980839	SUN PHARM	Topical aqueous nanomicellar, ophthalmic solutions and uses thereof	Aug, 2033 (9 years from now)
US10918694	SUN PHARM	Topical cyclosporine-containing formulations and uses thereof	Feb, 2037 (12 years from now)

Drugs and Companies using CYCLOSPORINE ingredient

Market Authorisation Date: 14 August, 2018

Treatment: Increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Dosage: SOLUTION;OPHTHALMIC

Strength	Dosage	Availability
0.09%	SOLUTION;OPHTHALMIC	Prescription

CEQUA family patents

5. Drizalma Sprinkle patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10959982	SUN PHARM	Duloxetine sprinkles	Apr, 2037 (12 years from now)
US9839626	SUN PHARM	Duloxetine sprinkles	Apr, 2037 (12 years from now)
US11202772	SUN PHARM	Duloxetine sprinkles	Apr, 2037 (12 years from now)
US10413525	SUN PHARM	Duloxetine sprinkles	Apr, 2037 (12 years from now)

Drugs and Companies using DULOXETINE HYDROCHLORIDE ingredient

Market Authorisation Date: 19 July, 2019

Treatment: NA

Dosage: CAPSULE, DELAYED REL PELLETS;ORAL

Strength	Dosage	Availability
EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Discontinued
EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Discontinued
EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Discontinued
EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Discontinued

DRIZALMA SPRINKLE family patents

6. Ezallor Sprinkle patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10413543	SUN PHARM	Stable multiparticulate pharmaceutical composition of rosuvastatin	Feb, 2036 (11 years from now)

Drugs and Companies using ROSUVASTATIN CALCIUM ingredient

Market Authorisation Date: 18 December, 2018

Treatment: NA

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
EQ 10MG BASE	CAPSULE;ORAL	Discontinued
EQ 5MG BASE	CAPSULE;ORAL	Discontinued
EQ 20MG BASE	CAPSULE;ORAL	Discontinued
EQ 40MG BASE	CAPSULE;ORAL	Discontinued

EZALLOR SPRINKLE family patents

7. Infugem patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP13165862A	2016-01-08	Generics (U.K.) Limited	Patent maintained as amended

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9241948	SUN PHARM	Ready to be infused gemcetabine solution	Jul, 2033 (9 years from now)

Drugs and Companies using GEMCITABINE HYDROCHLORIDE ingredient

Market Authorisation Date: 16 July, 2018

Treatment: NA

Dosage: SOLUTION;INTRAVENOUS

Strength	Dosage	Availability
EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued
EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued

INFUGEM family patents

8. Odomzo patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8178563	SUN PHARM	Compounds and compositions as hedgehog pathway modulators	Jul, 2029 (5 years from now)
US8063043	SUN PHARM	Salts of N-[6-cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4′-(trifluoromethoxy)[1,1′-biphenyl]-3-carboxamide	Sep, 2029 (5 years from now)
US10266523	SUN PHARM	Crystaline forms of N-[6-(cis-2,6-dimethylmorpholine-4-yl)pyridine-3-yl]-2-Methyl-4′-(trifluoromethoxy) [1,1′-biphenyl]-3-Methanamide monophosphate, and process of preparation thereof	Mar, 2036 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 24, 2020

Drugs and Companies using SONIDEGIB PHOSPHATE ingredient

NCE-1 date: 25 July, 2019

Market Authorisation Date: 24 July, 2015

Treatment: Treatment of basal cell carcinoma

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
EQ 200MG BASE	CAPSULE;ORAL	Prescription

ODOMZO family patents

9. Riomet Er patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP15786792A	2021-08-11	Reckitt Benckiser Health Limited	Granted and Under Opposition

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9962336	SUN PHARM	Extended release suspension compositions	May, 2035 (11 years from now)

Drugs and Companies using METFORMIN HYDROCHLORIDE ingredient

Market Authorisation Date: 29 August, 2019

Treatment: NA

Dosage: FOR SUSPENSION, EXTENDED RELEASE;ORAL

Strength	Dosage	Availability
500MG/5ML	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Discontinued

RIOMET ER family patents

10. Winlevi patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8865690	SUN PHARM	17alfa, 21-dihydroxypregnene esters as antiandrogenic agents	Jul, 2024 (2 months from now)
US9211295	SUN PHARM	17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents	Jul, 2024 (2 months from now)
US8143240	SUN PHARM	17α, 21-dihydroxypregnene esters as antiandrogenic agents	Jan, 2025 (8 months from now)
US9486458	SUN PHARM	Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives	Jul, 2028 (4 years from now)
US10159682	SUN PHARM	Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives	Aug, 2028 (4 years from now)
US11207332	SUN PHARM	Enzymatic process for obtaining 17 α-monoesters of cortexolone and/or its 9,11-dehydroderivatives	Nov, 2028 (4 years from now)
US9433628	SUN PHARM	Enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives	Feb, 2029 (4 years from now)
US8785427	SUN PHARM	Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives	Jul, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 26, 2025

Drugs and Companies using CLASCOTERONE ingredient

NCE-1 date: 26 August, 2024

Market Authorisation Date: 26 August, 2020

Treatment: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate; Method of treating acne vulgaris with topically applied cortexolone 17alpha-propionate

Dosage: CREAM;TOPICAL

Strength	Dosage	Availability
1%	CREAM;TOPICAL	Prescription

WINLEVI family patents

11. Xelpros patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9629852	June, 2013	Decision	Ajay Jaysingh Khopade et al

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9539262	SUN PHARM	Ophthalmic composition comprising a prostaglandin	Oct, 2028 (4 years from now)
US9629852	SUN PHARM	Ophthalmic composition comprising a prostaglandin	Sep, 2029 (5 years from now)

Drugs and Companies using LATANOPROST ingredient

Market Authorisation Date: 12 September, 2018

Treatment: Reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Dosage: EMULSION;OPHTHALMIC

Strength	Dosage	Availability
0.005%	EMULSION;OPHTHALMIC	Prescription

XELPROS family patents

12. Yonsa patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9889144	SUN PHARM	Abiraterone acetate formulation and methods of use	Mar, 2034 (9 years from now)
US10292990	SUN PHARM	Abiraterone steroid formulation	May, 2034 (10 years from now)

Drugs and Companies using ABIRATERONE ACETATE ingredient

Market Authorisation Date: 22 May, 2018

Treatment: Use in combination with methylprednisolone for the treatment of patients with prostate cancer

Dosage: TABLET;ORAL

Pharsight

Sun Pharm patents expiration

1. Absorica Ld patents expiration

ABSORICA LD family patents

2. Bromsite patents expiration

BROMSITE family patents

3. Bynfezia Pen patents expiration

BYNFEZIA PEN family patents

4. Cequa patents expiration

CEQUA family patents

5. Drizalma Sprinkle patents expiration

DRIZALMA SPRINKLE family patents

6. Ezallor Sprinkle patents expiration

EZALLOR SPRINKLE family patents

7. Infugem patents expiration

INFUGEM family patents

8. Odomzo patents expiration

ODOMZO family patents

9. Riomet Er patents expiration

RIOMET ER family patents

10. Winlevi patents expiration

WINLEVI family patents

11. Xelpros patents expiration

XELPROS family patents

12. Yonsa patents expiration

YONSA family patents

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