PAROXETINE HYDROCHLORIDE Drug Patent Profile
✉ Email this page to a colleague
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, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Prinston Inc, Sciecure Pharma Inc, Apotex, Aurobindo Pharma, Chartwell Rx, Jubilant Generics, Mylan, Norvium Bioscience, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa. and is included in twenty-four NDAs.
The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-three 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for PAROXETINE HYDROCHLORIDE?
- What are the global sales for PAROXETINE HYDROCHLORIDE?
- What is Average Wholesale Price for PAROXETINE HYDROCHLORIDE?
Summary for PAROXETINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 23 |
| NDAs: | 24 |
| Finished Product Suppliers / Packagers: | 40 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 259 |
| Patent Applications: | 1,037 |
| 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 |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | N/A |
| Cairo University | Phase 3 |
| The Medical Research Network | Phase 4 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yiling | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 211248-003 | Nov 2, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Jubilant Generics | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 205528-004 | Nov 27, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078406-003 | Jul 25, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Norvium Bioscience | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 075716-004 | Mar 8, 2004 | DISCN | 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 |
