Paroxetine mesylate - Generic Drug Details

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

Paroxetine mesylate is the generic ingredient in three branded drugs marketed by Sebela Ireland Ltd, Actavis Labs Fl Inc, and Prinston Inc, and is included in four NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paroxetine mesylate has eighty-four patent family members in thirty-six countries.

There are two drug master file entries for paroxetine mesylate. Two suppliers are listed for this compound.

Summary for paroxetine mesylate

International Patents:	84
US Patents:	4
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	5
Patent Applications:	310
Drug Prices:	Drug price trends for paroxetine mesylate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paroxetine mesylate
What excipients (inactive ingredients) are in paroxetine mesylate?	paroxetine mesylate excipients list
DailyMed Link:	paroxetine mesylate at DailyMed

See drug prices for paroxetine mesylate

Recent Clinical Trials for paroxetine mesylate

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

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
Noven Therapeutics	Phase 1

See all paroxetine mesylate clinical trials

Pharmacology for paroxetine mesylate

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for paroxetine mesylate

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

Paragraph IV (Patent) Challenges for PAROXETINE MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRISDELLE	Capsules	paroxetine mesylate	7.5 mg	204516	1	2014-04-07

US Patents and Regulatory Information for paroxetine mesylate

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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
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-003	Jul 3, 2003		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Prinston Inc	PAROXETINE MESYLATE	paroxetine mesylate	CAPSULE;ORAL	207188-001	Aug 18, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	⤷ 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 mesylate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-004	Jul 3, 2003	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-001	Jul 3, 2003	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-002	Jul 3, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for paroxetine mesylate

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Country	Patent Number	Title	Estimated Expiration
Norway	20090639		⤷ Sign Up
Poland	2719385		⤷ Sign Up
South Korea	20140098865		⤷ Sign Up
Germany	69704679		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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