BRISDELLE Drug Patent Profile

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When do Brisdelle patents expire, and when can generic versions of Brisdelle launch?

Brisdelle is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four patent family members in thirty-six countries.

The generic ingredient in BRISDELLE is paroxetine mesylate. There are thirty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brisdelle

A generic version of BRISDELLE was approved as paroxetine mesylate by ACTAVIS LABS FL INC on June 20^th, 2017.

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Summary for BRISDELLE

International Patents:	84
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	4
Patent Applications:	176
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BRISDELLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRISDELLE
What excipients (inactive ingredients) are in BRISDELLE?	BRISDELLE excipients list
DailyMed Link:	BRISDELLE at DailyMed

Drug patent expirations by year for BRISDELLE

Recent Clinical Trials for BRISDELLE

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

Sponsor	Phase
Noven Therapeutics	Phase 1
Noven Therapeutics	Phase 3
Noven Therapeutics	Phase 2

See all BRISDELLE clinical trials

Paragraph IV (Patent) Challenges for BRISDELLE

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 BRISDELLE

BRISDELLE is protected by four US patents.

Patents protecting BRISDELLE

Crystalline paroxetine methane sulfonate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Method of treating thermoregulatory disfunction with paroxetine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Method of treating thermoregulatory dysfunction with paroxetine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

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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	Y		⤷ Sign Up
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	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	⤷ 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	Y	Y		⤷ 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 BRISDELLE

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

International Patents for BRISDELLE

See the table below for patents covering BRISDELLE around the world.

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Country	Patent Number	Title	Estimated Expiration
Serbia	57980		⤷ Sign Up
Australia	2007282065		⤷ Sign Up
Israel	196844	Paroxetine for use in the treatment of a thermoregulatory dysfunction associated with menopause	⤷ Sign Up
Germany	29724281		⤷ Sign Up
Serbia	58046	METHOD OF TREATING THERMOREGULATORY DISFUNCTION WITH PAROXETINE	⤷ Sign Up
Germany	69704679		⤷ Sign Up
Norway	20033765		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration