Pharsight

1. List of Bosulif 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.
USRE42376	PF PRISM CV	Substituted 3-cyanoquinolines	Apr, 2024 (1 year, 2 months from now)
US7767678	PF PRISM CV	Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same	Nov, 2026 (3 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7417148	PF PRISM CV	4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)	Dec, 2025 (2 years from now)
US7919625	PF PRISM CV	4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)	Dec, 2025 (2 years from now)
US11103497	PF PRISM CV	Treatment of imatinib resistant leukemia	Feb, 2034 (11 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 19, 2024

Drugs and Companies using BOSUTINIB MONOHYDRATE ingredient

Market Authorisation Date: 04 September, 2012

Treatment: A method of treating chronic myelogenous leukemia; A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the bcrabl protein at 949t>c; A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the bcrabl protein at f317l

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg and 500 mg	06 Sep, 2016	2		23 Nov, 2026
400 mg	25 Oct, 2018	1		23 Nov, 2026

Strength	Dosage	Availability
EQ 100MG BASE	TABLET;ORAL	Prescription
EQ 400MG BASE	TABLET;ORAL	Prescription
EQ 500MG BASE	TABLET;ORAL	Prescription

2. List of Chantix 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.
US6890927	PF PRISM CV	Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof	May, 2022 (8 months ago)
US7265119	PF PRISM CV	Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.02,11.04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof	Aug, 2022 (6 months ago)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6890927 (Pediatric)	PF PRISM CV	Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof	Nov, 2022 (2 months ago)
US7265119 (Pediatric)	PF PRISM CV	Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.02,11.04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof	Feb, 2023 (13 hours from now)

Exclusivity	Exclusivity Expiration
M	Feb 22, 2022
Pediatric Exclusivity (PED)	Aug 22, 2022

Drugs and Companies using VARENICLINE TARTRATE ingredient

Market Authorisation Date: 10 May, 2006

Treatment: Aid to smoking cessation

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.5 mg and 1 mg	10 May, 2010	5	11 Aug, 2021	03 Aug, 2022	Deferred

Strength	Dosage	Availability
EQ 0.5MG BASE	TABLET;ORAL	Prescription
EQ 1MG BASE	TABLET;ORAL	Prescription

3. List of Inlyta 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.
US6534524	PF PRISM CV	Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use	Apr, 2025 (2 years from now)
US8791140	PF PRISM CV	Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals	Dec, 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).
US10570202	PF PRISM CV	Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer	Feb, 2035 (12 years from now)
US10869924	PF PRISM CV	PD-L1 antagonist combination treatments	Jan, 2037 (13 years from now)

Drugs and Companies using AXITINIB ingredient

Market Authorisation Date: 27 January, 2012

Treatment: In combination with pembrolizumab for the first-line treatment of patients with advanced renal cell carcinoma; Axitinib in combination with avelumab for the first-line treatment of patients with advanced renal cell carcinoma

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
1 mg and 5 mg	23 Feb, 2018	1		14 Dec, 2030

Strength	Dosage	Availability
1MG	TABLET;ORAL	Prescription
5MG	TABLET;ORAL	Prescription

4. List of Pristiq 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.
US6673838	PF PRISM CV	Succinate salt of O-desmethyl-venlafaxine	Mar, 2022 (11 months ago)
US8269040	PF PRISM CV	Derivatives of venlafaxine and methods of preparing and using the same	Jul, 2027 (4 years from now)

Drugs and Companies using DESVENLAFAXINE SUCCINATE ingredient

Market Authorisation Date: 29 February, 2008

Treatment: For the approved uses and conditions of use, including depression; Maintenance treatment of major depressive disorder (mdd)

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg and 100 mg	29 Feb, 2012	12	29 Jun, 2015	11 Feb, 2022	Eligible
25 mg	08 May, 2015	1	29 Jul, 2016	05 Jul, 2027	Eligible

Strength	Dosage	Availability
EQ 25MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 100MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription

5. List of Torisel 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).
US8455539	PF PRISM CV	CCI-779 concentrate formulations	Jul, 2023 (5 months from now)
US8299116	PF PRISM CV	CCI-779 concentrate formulations	Jul, 2023 (5 months from now)
US8722700	PF PRISM CV	CCI-779 formulations for parenteral administration	Jul, 2023 (5 months from now)
US8299116 (Pediatric)	PF PRISM CV	CCI-779 concentrate formulations	Jan, 2024 (11 months from now)
US8722700 (Pediatric)	PF PRISM CV	CCI-779 formulations for parenteral administration	Jan, 2024 (11 months from now)
US8455539 (Pediatric)	PF PRISM CV	CCI-779 concentrate formulations	Jan, 2024 (11 months from now)
US8026276	PF PRISM CV	Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant	Jan, 2026 (2 years from now)
US8026276 (Pediatric)	PF PRISM CV	Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant	Jul, 2026 (3 years from now)
US8791097	PF PRISM CV	Anti-tumor activity of CCI-779 in papillary renal cell cancer	May, 2032 (9 years from now)
US8791097 (Pediatric)	PF PRISM CV	Anti-tumor activity of CCI-779 in papillary renal cell cancer	Nov, 2032 (9 years from now)

Drugs and Companies using TEMSIROLIMUS ingredient

Market Authorisation Date: 30 May, 2007

Treatment: Method of treating papillary renal cell carcinoma with temsirolimus, in the absence of interferon alpha.; Method of treating metastatic papillary renal cell carcinoma with temsirolimus.

Dosage: SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg/mL, 1.8 mL vial	25 May, 2011	1		18 Apr, 2014	Extinguished

Strength	Dosage	Availability
25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription

6. List of Tygacil 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).
US9694078	PF PRISM CV	Tigecycline compositions and methods of preparation	Mar, 2026 (3 years from now)
US10588975	PF PRISM CV	Tigecycline compositions and methods of preparation	Mar, 2026 (3 years from now)
US9254328	PF PRISM CV	Tigecycline compositions and methods of preparation	Mar, 2026 (3 years from now)
US8975242	PF PRISM CV	Tigecycline compositions and methods of preparation	Oct, 2028 (5 years from now)
US7879828	PF PRISM CV	Tigecycline compositions and methods of preparation	Feb, 2029 (6 years from now)
US8372995	PF PRISM CV	Crystalline solid forms of tigecycline and methods of preparing same	Oct, 2030 (7 years from now)

Drugs and Companies using TIGECYCLINE ingredient

Market Authorisation Date: 15 June, 2005

Treatment: NA

Dosage: POWDER;INTRAVENOUS

Strength	Dosage	Availability
50MG/VIAL	POWDER;INTRAVENOUS	Prescription

7. List of Xalkori 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.
US8785632	PF PRISM CV	Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors	Mar, 2025 (2 years from now)
US7230098	PF PRISM CV	Aminoheteroaryl compounds as protein kinase inhibitors	Aug, 2025 (2 years from now)
US7858643	PF PRISM CV	Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors	Oct, 2029 (6 years from now)
US8217057	PF PRISM CV	Polymorphs of a c-MET/HGFR inhibitor	Nov, 2029 (6 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7825137	PF PRISM CV	Method of treating abnormal cell growth	May, 2027 (4 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Jan 14, 2028
New Indication (I)	Jul 14, 2025

Drugs and Companies using CRIZOTINIB ingredient

Market Authorisation Date: 26 August, 2011

Treatment: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (alcl) that is anaplastic lymphoma kinase (alk)-positive; Treatment of patients with metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
200MG	CAPSULE;ORAL	Prescription
250MG	CAPSULE;ORAL	Prescription

8. List of Xeljanz 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.
US6965027	PF PRISM CV	Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate	Mar, 2023 (a month from now)
USRE41783	PF PRISM CV	Pyrrolo[2,3-D]pyrimidine compounds	Dec, 2025 (2 years from now)

Exclusivity	Exclusivity Expiration
New Indication (I)	Dec 14, 2024
New Patient Population (NPP)	Sep 25, 2023

Drugs and Companies using TOFACITINIB CITRATE ingredient

Market Authorisation Date: 06 November, 2012

Treatment: NA

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg	07 Nov, 2016	3		08 Dec, 2025
10 mg	24 Jul, 2019	1	01 Jun, 2021	08 Dec, 2025	Eligible
1 mg/mL	12 Nov, 2021	1		08 Dec, 2025

Strength	Dosage	Availability
EQ 5MG BASE	TABLET;ORAL	Prescription
EQ 10MG BASE	TABLET;ORAL	Prescription

9. List of Zmax 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).
US6984403	PF PRISM CV	Azithromycin dosage forms with reduced side effects	Feb, 2024 (1 year, 11 days from now)
US7887844	PF PRISM CV	Multiparticulate crystalline drug compositions having controlled release profiles	Feb, 2024 (1 year, 11 days from now)