Paroxetine hydrochloride - Generic Drug Details
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What are the generic drug sources for paroxetine hydrochloride and what is the scope of patent protection?
Paroxetine hydrochloride
is the generic ingredient in four branded drugs marketed by Apotex, 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, 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-nine NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-four drug master file entries for paroxetine hydrochloride. Forty-three suppliers are listed for this compound.
Summary for paroxetine hydrochloride
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 23 |
| NDAs: | 29 |
| Drug Master File Entries: | 24 |
| Finished Product Suppliers / Packagers: | 43 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 259 |
| Patent Applications: | 1,607 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upsher Smith Labs | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 075566-001 | Mar 8, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cspc Ouyi | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213485-001 | Feb 16, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cspc Ouyi | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213485-003 | Feb 16, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Prinston Inc | PAROXETINE | paroxetine hydrochloride | TABLET;ORAL | 203854-004 | Oct 31, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204134-001 | Jan 20, 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 hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-001 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-001 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-004 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-001 | Oct 9, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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