PAROXETINE MESYLATE Drug Patent Profile
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Which patents cover Paroxetine Mesylate, and what generic alternatives are available?
Paroxetine Mesylate is a drug marketed by Actavis Labs Fl Inc and Prinston Inc and is included in two NDAs.
The generic ingredient in PAROXETINE MESYLATE is paroxetine mesylate. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Paroxetine Mesylate
A generic version of PAROXETINE MESYLATE was approved as paroxetine mesylate by ACTAVIS LABS FL INC on June 20th, 2017.
Summary 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Fl Inc | PAROXETINE MESYLATE | paroxetine mesylate | CAPSULE;ORAL | 207139-001 | Jun 20, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Prinston Inc | PAROXETINE MESYLATE | paroxetine mesylate | CAPSULE;ORAL | 207188-001 | Aug 18, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
