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Serving leading biopharmaceutical companies globally:

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Generated: December 14, 2017

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Sertraline hydrochloride - Generic Drug Details

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What are the generic sources for sertraline hydrochloride and what is the scope of sertraline hydrochloride freedom to operate?

Sertraline hydrochloride
is the generic ingredient in two branded drugs marketed by Allied Pharma Inc, Aurobindo Pharma, Ranbaxy Labs Ltd, Pfizer, Accord Hlthcare, Aci Healthcare Ltd, Actavis Elizabeth, Anda Repository, Apotex Inc, Austarpharma Llc, Cipla Ltd, Dr Reddys Labs Ltd, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Pliva Hrvatska Doo, Sandoz, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Torrent Pharms, Watson Labs Teva, Wockhardt, and Zydus Pharms Usa, 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.

Sertraline hydrochloride has fifty-two 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 are two tentative approvals for this compound.

Pharmacology for sertraline hydrochloride

Medical Subject Heading (MeSH) Categories for sertraline hydrochloride

Tentative approvals for SERTRALINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 25MG BASETABLET;ORAL
u► SubscribeEQ 100MG BASETABLET;ORAL
u► SubscribeEQ 50MG BASETABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Actavis ElizabethSERTRALINE HYDROCHLORIDEsertraline hydrochlorideTABLET;ORAL077345-001Feb 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-005Mar 6, 1996ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-001Dec 30, 1991ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm Inds LtdSERTRALINE HYDROCHLORIDEsertraline hydrochlorideTABLET;ORAL077977-002Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Anda RepositorySERTRALINE HYDROCHLORIDEsertraline hydrochlorideTABLET;ORAL077818-003Feb 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncSERTRALINE HYDROCHLORIDEsertraline hydrochlorideTABLET;ORAL076882-001Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-002Dec 30, 1991ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Hikma PharmsSERTRALINE HYDROCHLORIDEsertraline hydrochlorideTABLET;ORAL077864-003Aug 10, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Torrent PharmsSERTRALINE HYDROCHLORIDEsertraline hydrochlorideTABLET;ORAL077765-001Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncSERTRALINE HYDROCHLORIDEsertraline hydrochlorideTABLET;ORAL076540-003Mar 20, 2007DISCNNoNo► Subscribe► Subscribe► 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
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-001Dec 30, 1991► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-001Dec 30, 1991► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-002Dec 30, 1991► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-004Dec 30, 1991► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-005Mar 6, 1996► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-004Dec 30, 1991► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-004Dec 30, 1991► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-005Mar 6, 1996► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideCONCENTRATE;ORAL020990-001Dec 7, 1999► Subscribe► Subscribe
PfizerZOLOFTsertraline hydrochlorideTABLET;ORAL019839-002Dec 30, 1991► Subscribe► Subscribe
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International Patent Family for Ingredient: sertraline hydrochloride

Country Document Number Estimated Expiration
South Korea100417200► Subscribe
Indonesia29845► Subscribe
Hungary0104470► Subscribe
Denmark1121107► Subscribe
TunisiaSN99190► Subscribe
Japan3792514► Subscribe
Algeria2913► Subscribe
CroatiaP20010263► Subscribe
Germany69912978► Subscribe
Bulgaria65085► 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 leading biopharmaceutical companies globally:

Baxter
Cipla
Fish and Richardson
Queensland Health
Colorcon
Accenture
Daiichi Sankyo
AstraZeneca
Dow
Medtronic

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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