Paroxetine hydrochloride - Generic Drug Details

What are the generic drug sources for paroxetine hydrochloride and what is the scope of patent protection?

Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Apotex, Apotex Inc, Novitium Pharma, Aurobindo Pharma Usa, Cadila Pharms Ltd, Cspc Ouyi, Lannett Co Inc, Lupin Ltd, Sciecure Pharma Inc, Sinotherapeutics Inc, Prinston Inc, Aurobindo Pharma, Chartwell Rx, Jubilant Generics, Mylan, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for paroxetine hydrochloride. Forty-one suppliers are listed for this compound.

Summary for paroxetine hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	23
NDAs:	28
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	253
Patent Applications:	1,714
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paroxetine hydrochloride
What excipients (inactive ingredients) are in paroxetine hydrochloride?	paroxetine hydrochloride excipients list
DailyMed Link:	paroxetine hydrochloride at DailyMed

Recent Clinical Trials for paroxetine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AbbVie	Phase 4
The Medical Research Network	Phase 4
University of Toronto	Phase 3

See all paroxetine hydrochloride clinical trials

Pharmacology for paroxetine hydrochloride

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for PAROXETINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PAXIL CR	Extended-release Tablets	paroxetine hydrochloride	37.5 mg	020936	1	2009-05-19
PAXIL CR	Extended-release Tablets	paroxetine hydrochloride	25 mg	020936	1	2005-09-09

US Patents and Regulatory Information for paroxetine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upsher Smith Labs	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	075566-003	Mar 8, 2004		DISCN	No	No
Mylan	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078902-001	Mar 13, 2008	AB	RX	No	No
Mylan	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078902-002	Mar 13, 2008	AB	RX	No	No
Jubilant Generics	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	205528-004	Nov 27, 2015		DISCN	No	No
Mylan	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078902-003	Mar 13, 2008	AB	RX	No	No
Aurobindo Pharma	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078406-002	Jul 25, 2007	AB	RX	No	No

Expired US Patents for paroxetine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-004	Oct 9, 1998
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-002	Feb 16, 1999
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-003	Oct 9, 1998
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-004	Dec 29, 1992
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-003	Dec 6, 2000
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-002	Feb 16, 1999