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Paroxetine hydrochloride - Generic Drug Details

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Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Mylan, Aurobindo Pharma, Apotex Technologies, Mylan Pharms Inc, Teva, Roxane, Jubilant Generics, Kremers Urban Pharms, Prinston Inc, Apotex, Sandoz, Oxford Pharms, Teva Pharms, Zydus Pharms Usa, Sun Pharm Inds Inc, and Apotex Inc, and is included in twenty-one NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and fifty-six patent family members in fifty-seven countries.

There are twenty-nine drug master file entries for paroxetine hydrochloride. Fifty-one suppliers are listed for this compound.

Summary for Generic Name: paroxetine hydrochloride

Tradenames:4
Patents:10
Applicants:16
NDAs:21
Drug Master File Entries: see list29
Suppliers / Packaging: see list51
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: paroxetine hydrochloride

Clinical Trials for: paroxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL078406-001Jul 25, 2007RXNo<disabled><disabled>
Zydus Pharms Usa
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL077584-004Mar 7, 2007RXNo<disabled><disabled>
Mylan Pharms Inc
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL075716-001Mar 8, 2004RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: paroxetine hydrochloride

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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;ORAL020936-002Feb 16, 19995,900,423*PED<disabled>
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 19986,133,289*PED<disabled>
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-004Dec 29, 19925,789,449*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: paroxetine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,856,493 Process for making novel form of paroxeting hydrochloride anhydrate<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: paroxetine hydrochloride

Country Document Number Estimated Expiration
Austria178489<disabled in preview>
Denmark200100774<disabled in preview>
Czech Republic285128<disabled in preview>
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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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