PAROXETINE HYDROCHLORIDE Drug Patent Profile
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When do Paroxetine Hydrochloride patents expire, and what generic alternatives are available?
Paroxetine Hydrochloride is a drug marketed by Apotex Inc, Novitium Pharma, Aurobindo Pharma Usa, Cadila Pharms Ltd, Cspc Ouyi, Lannett Co Inc, Lupin Ltd, Sciecure Pharma Inc, Sinotherapeutics Inc, Apotex, Aurobindo Pharma, Chartwell Rx, Jubilant Generics, Mylan, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa. and is included in twenty-three NDAs.
The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Paroxetine Hydrochloride
A generic version of PAROXETINE HYDROCHLORIDE was approved as paroxetine hydrochloride by APOTEX on July 30th, 2003.
Summary for PAROXETINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 23 |
| Finished Product Suppliers / Packagers: | 37 |
| Raw Ingredient (Bulk) Api Vendors: | 94 |
| Clinical Trials: | 250 |
| Patent Applications: | 1,070 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| University of New Mexico | Phase 2 |
| University Hospital, Basel, Switzerland | Phase 1 |
| Everest Clinical Research | Phase 2 |
Pharmacology for PAROXETINE HYDROCHLORIDE
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PAROXETINE HYDROCHLORIDE
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
PAROXETINE HYDROCHLORIDE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting PAROXETINE HYDROCHLORIDE
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: See Plans and Pricing
