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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 Technologies, Apotex Inc, Lannett Co Inc, Lupin Ltd, Mylan, Sciecure Pharma Inc, Prinston Inc, Apotex, Aurobindo Pharma, Jubilant Generics, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva, Teva Pharms, Upsher Smith Labs, and Zydus Pharms Usa, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.There are thirty drug master file entries for paroxetine hydrochloride. Thirty-eight suppliers are listed for this compound.
Summary for paroxetine hydrochloride
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 18 |
NDAs: | 23 |
Drug Master File Entries: | 30 |
Suppliers / Packagers: | 38 |
Bulk Api Vendors: | 91 |
Clinical Trials: | 239 |
Patent Applications: | 1,255 |
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 |
---|---|
Washington State University | N/A |
Harvard University | N/A |
Patient-Centered Outcomes Research Institute | N/A |
Pharmacology for paroxetine hydrochloride
Drug Class | Serotonin Reuptake Inhibitor |
Mechanism of Action | Serotonin Uptake Inhibitors |
Paragraph IV (Patent) Challenges for PAROXETINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
PAXIL CR | TABLET, EXTENDED RELEASE;ORAL | paroxetine hydrochloride | 020936 | 2009-05-19 |
PAXIL CR | TABLET, EXTENDED RELEASE;ORAL | paroxetine hydrochloride | 020936 | 2005-09-09 |
PAXIL | SUSPENSION;ORAL | paroxetine hydrochloride | 020710 | 2005-02-10 |
PAXIL | TABLET;ORAL | paroxetine hydrochloride | 020031 | |
PAXIL | CAPSULE;ORAL | paroxetine hydrochloride | 020885 |
US Patents and Regulatory Information for paroxetine hydrochloride
Expired US Patents for paroxetine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apotex Technologies | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-004 | Dec 29, 1992 | Start Trial | Start Trial |
Apotex Technologies | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | Start Trial | Start Trial |
Apotex Technologies | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | Start Trial | Start Trial |
Apotex Technologies | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-005 | Dec 29, 1992 | Start Trial | Start Trial |
Apotex Technologies | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-002 | Oct 9, 1998 | Start Trial | Start Trial |
Apotex Technologies | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-002 | Dec 29, 1992 | Start Trial | Start Trial |
Apotex Technologies | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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