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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. Sixty-one 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 list61
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Drug Prices:see low prices

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
Invagen Pharms
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077397-003Feb 6, 2007RXNo
Pliva Hrvatska Doo
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077299-001Feb 6, 2007DISCNNo
Wockhardt
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL078403-002Jan 8, 2008RXNo
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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;ORAL019839-005Mar 6, 19964,962,128*PED<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-003Dec 30, 19914,536,518*PED<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-001Dec 30, 19915,744,501<disabled>
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International Patent Family for Ingredient: sertraline hydrochloride

Country Document Number Estimated Expiration
Slovenia1121107<disabled in preview>
Eurasian Patent Organization003990<disabled in preview>
African Intellectual Property Organization (OAPI)11662<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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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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