PAROXETINE Drug Patent Profile
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When do Paroxetine patents expire, and what generic alternatives are available?
Paroxetine is a drug marketed by Prinston Inc, Apotex Inc, Novitium Pharma, Aurobindo Pharma Usa, Cadila Pharms Ltd, Cspc Ouyi, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Sciecure Pharma 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, Zydus Pharms Usa, and Actavis Labs Fl Inc. and is included in twenty-seven NDAs.
The generic ingredient in PAROXETINE 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
A generic version of PAROXETINE was approved as paroxetine mesylate by ACTAVIS LABS FL INC on June 20th, 2017.
Summary for PAROXETINE
| US Patents: | 0 |
| Applicants: | 24 |
| NDAs: | 27 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 257 |
| Patent Applications: | 3,903 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PAROXETINE |
| Drug Sales Revenues: | Drug sales revenues for PAROXETINE |
| What excipients (inactive ingredients) are in PAROXETINE? | PAROXETINE excipients list |
| DailyMed Link: | PAROXETINE at DailyMed |
See drug prices for PAROXETINE
Recent Clinical Trials for PAROXETINE
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
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PAROXETINE
US Patents and Regulatory Information for PAROXETINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upsher Smith Labs | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 075566-003 | Mar 8, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chartwell Rx | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 076618-004 | Aug 15, 2005 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 075356-003 | Jul 30, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078902-004 | Mar 13, 2008 | 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 |
