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Generated: July 22, 2017
What are the generic sources for paroxetine hydrochloride and what is the scope of paroxetine hydrochloride freedom to operate?
Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Mylan, Aurobindo Pharma, Apotex Technologies, Mylan Pharms Inc, Teva, Roxane, Jubilant Generics, Lupin Ltd, Kremers Urban Pharms, Prinston Inc, Apotex, Upsher-smith Labs, Oxford Pharms, Teva Pharms, Zydus Pharms Usa, Sun Pharm Inds Inc, and Apotex Inc, and is included in twenty-two NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 4 |
| Patents: | 6 |
| Applicants: | 17 |
| NDAs: | 22 |
| Drug Master File Entries: see list | 30 |
| Suppliers / Packagers: see list | 54 |
| Bulk Api Vendors: see list | 107 |
| Clinical Trials: see list | 2,430 |
| Patent Applications: see list | 5,735 |
| Therapeutic Class: | Anxiolytics |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | paroxetine hydrochloride at DailyMed |
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | EQ 10MG BASE | TABLET;ORAL |
| ► Subscribe | ► Subscribe | EQ 40MG BASE | TABLET;ORAL |
| ► Subscribe | ► Subscribe | EQ 30MG BASE | TABLET;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078406-004 | Jul 25, 2007 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Prinston Inc | PAROXETINE | paroxetine hydrochloride | TABLET;ORAL | 203854-001 | Oct 31, 2014 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Apotex Technologies | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | DISCN | Yes | No | 6,063,927*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Apotex Technologies | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | AB | RX | Yes | Yes | 7,229,640*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Oxford Pharms | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 076968-002 | Jun 21, 2010 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex Technologies | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | 6,080,759*PED | ► Subscribe | ||||||||||||||||||||||
Apotex Technologies | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | 4,721,723*PED | ► Subscribe | ||||||||||||||||||||||
Apotex Technologies | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-001 | Dec 29, 1992 | 6,080,759*PED | ► Subscribe | ||||||||||||||||||||||
Apotex Technologies | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-001 | Oct 9, 1998 | 5,789,449*PED | ► Subscribe | ||||||||||||||||||||||
Apotex Technologies | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-004 | Dec 29, 1992 | 4,721,723*PED | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| China | 1117567 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1020464 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 3619199 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1382337 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 970955 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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