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Paroxetine hydrochloride - Generic Drug Details

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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 Technologies, Apotex Inc, Lannett Co Inc, Lupin Ltd, Mylan, Sciecure Pharma Inc, Prinston Inc, Apotex, Aurobindo Pharma, Jubilant Generics, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva, Teva Pharms, Upsher Smith Labs, and Zydus Pharms Usa, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for paroxetine hydrochloride. Thirty-eight suppliers are listed for this compound.

Summary for paroxetine hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	18
NDAs:	23
Drug Master File Entries:	30
Suppliers / Packagers:	38
Bulk Api Vendors:	91
Clinical Trials:	239
Patent Applications:	1,255
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
Washington State University	N/A
Harvard University	N/A
Patient-Centered Outcomes Research Institute	N/A

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	NDA	Submissiondate
PAXIL CR	TABLET, EXTENDED RELEASE;ORAL	paroxetine hydrochloride	020936	2009-05-19
PAXIL CR	TABLET, EXTENDED RELEASE;ORAL	paroxetine hydrochloride	020936	2005-09-09
PAXIL	SUSPENSION;ORAL	paroxetine hydrochloride	020710	2005-02-10
PAXIL	TABLET;ORAL	paroxetine hydrochloride	020031
PAXIL	CAPSULE;ORAL	paroxetine hydrochloride	020885

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
Apotex Technologies	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-003	Dec 29, 1992	AB	RX	Yes	No
Prinston Inc	PAROXETINE	paroxetine hydrochloride	TABLET;ORAL	203854-001	Oct 31, 2014	AB	RX	No	No
Jubilant Generics	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	205528-004	Nov 27, 2015		DISCN	No	No
Upsher Smith Labs	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	075566-004	Mar 8, 2004		DISCN	No	No
Apotex Technologies	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-001	Feb 16, 1999	AB	RX	Yes	No
Lannett Co Inc	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204744-001	Jun 10, 2016	AB	RX	No	No
Teva Pharms	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	077082-004	Jun 29, 2007		DISCN	No	No

Expired US Patents for paroxetine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex Technologies	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-004	Dec 29, 1992
Apotex Technologies	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-003	Oct 9, 1998
Apotex Technologies	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-004	Oct 9, 1998
Apotex Technologies	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-005	Dec 29, 1992
Apotex Technologies	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-002	Oct 9, 1998
Apotex Technologies	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-002	Dec 29, 1992
Apotex Technologies	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-003	Dec 29, 1992