PAROXETINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for paroxetine hydrochloride and what is the scope of freedom to operate?

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, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Prinston Inc, Sciecure Pharma Inc, Aurobindo Pharma, Chartwell Rx, Jubilant Generics, Mylan, Norvium Bioscience, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for PAROXETINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	23
NDAs:	29
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	259
Patent Applications:	1,607
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
First Affiliated Hospital Xi'an Jiaotong University	N/A
Cairo University	Phase 3
The Medical Research Network	Phase 4

See all PAROXETINE HYDROCHLORIDE clinical trials

Pharmacology for PAROXETINE HYDROCHLORIDE

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PAROXETINE HYDROCHLORIDE

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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Glossary

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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	075566-001	Mar 8, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cspc Ouyi	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	213485-001	Feb 16, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cspc Ouyi	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	213485-003	Feb 16, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for PAROXETINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-001	Dec 29, 1992	⤷ Sign Up	⤷ Sign Up
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-003	Dec 29, 1992	⤷ Sign Up	⤷ Sign Up
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-004	Oct 9, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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