PAROXETINE MESYLATE - Generic Drug Details
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What are the generic 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 |
Recent Clinical Trials for PAROXETINE MESYLATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Alphacait, LLC | Phase 2 |
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Noven Therapeutics | Phase 1 |
Pharmacology for PAROXETINE MESYLATE
Drug Class | Serotonin Reuptake Inhibitor |
Mechanism of Action | Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PAROXETINE MESYLATE
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
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 | |||
>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
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PAROXETINE MESYLATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 20090639 | ⤷ Sign Up | |
Poland | 2719385 | ⤷ Sign Up | |
South Korea | 20140098865 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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