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Sertraline hydrochloride - Generic Drug Details

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Sertraline hydrochloride is the generic ingredient in two branded drugs marketed by Wockhardt, Aurobindo Pharma, Zydus Pharms Usa, Sun Pharm Inds (in), Sandoz, Frontida Biopharm, Ivax Sub Teva Pharms, Accord Hlthcare, Mylan Pharms Inc, Roxane, Pfizer, Dr Reddys Labs Ltd, Actavis Elizabeth, Ranbaxy Labs Ltd, Cipla Ltd, Watson Labs, Hikma Pharms, Teva, Torrent Pharms, Lupin, Mylan, Oxford Pharms, Austarpharma Llc, Sun Pharm Inds Ltd, Apotex Inc, Invagen Pharms, and Pliva Hrvatska Doo, and is included in thirty-one NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-eight patent family members in forty-five countries.

There are twenty-two drug master file entries for sertraline hydrochloride. Fifty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: sertraline hydrochloride

Tradenames:2
Patents:2
Applicants:27
NDAs:31
Drug Master File Entries: see list22
Suppliers / Packaging: see list58
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: sertraline hydrochloride

Tentative approvals for SERTRALINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL150MG
<disabled><disabled>TABLET; ORAL200MG

Clinical Trials for: sertraline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077977-002Feb 6, 2007RXNo<disabled><disabled>
Aurobindo Pharma
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077206-001Feb 6, 2007RXNo<disabled><disabled>
Austarpharma Llc
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL078677-002Mar 4, 2009RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: sertraline hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-004Dec 30, 19914,536,518*PED<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-001Dec 30, 19914,536,518*PED<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-001Dec 30, 19915,789,449<disabled>
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International Patent Family for Ingredient: sertraline hydrochloride

Country Document Number Estimated Expiration
Poland348119<disabled in preview>
Morocco26698<disabled in preview>
Japan3792514<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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