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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-nine 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 / Packagers: see list59
Bulk Api Vendors: see list68
Clinical Trials: see list1,090
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sertraline hydrochloride at DailyMed

Pharmacology for Ingredient: sertraline hydrochloride

Tentative approvals for SERTRALINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL150MG
<disabled><disabled>TABLET; ORAL200MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077345-001Feb 6, 2007DISCNNoNo► subscribe► subscribe
Apotex Inc
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL076882-002Feb 6, 2007RXNoNo► subscribe► subscribe
Mylan
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL076671-003Feb 6, 2007RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: sertraline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-004Dec 30, 19914,536,518*PED► subscribe
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-001Dec 30, 19915,744,501► subscribe
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-002Dec 30, 19915,248,699*PED► subscribe
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International Patent Family for Ingredient: sertraline hydrochloride

Country Document Number Estimated Expiration
Malaysia122477► subscribe
African Intellectual Property Organization (OAPI)11662► subscribe
Australia766202► 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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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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