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Serving leading biopharmaceutical companies globally:

Novartis
Cantor Fitzgerald
Baxter
Argus Health
Citi
Fish and Richardson
US Army
QuintilesIMS
Merck
UBS

Generated: October 17, 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 Wockhardt, Aurobindo Pharma, Zydus Pharms Usa, Sun Pharm Inds (in), Sandoz, Anda Repository, Ivax Sub Teva Pharms, Accord Hlthcare, Mylan Pharms Inc, Allied Pharma Inc, Pfizer, Dr Reddys Labs Ltd, Actavis Elizabeth, Ranbaxy Labs Ltd, Cipla Ltd, Watson Labs Teva, Hikma Pharms, Teva, Torrent Pharms, Lupin, Mylan, Oxford Pharms, Austarpharma Llc, Sun Pharm Inds Ltd, Aci Healthcare 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.

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.

Summary for Generic Name: sertraline hydrochloride

US Patents:2
Tradenames:2
Applicants:28
NDAs:31
Drug Master File Entries: see list22
Suppliers / Packagers: see list61
Bulk Api Vendors: see list68
Clinical Trials: see list2,509
Patent Applications: see list4,449
Therapeutic Class: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. 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 Product Substance Delist Req. Exclusivity Expiration
Lupin
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077670-002Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Invagen Pharms
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077397-001Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077713-001Feb 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Wockhardt
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL078403-003Jan 8, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL076671-003Feb 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL075719-003Jun 30, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Ranbaxy Labs Ltd
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
CONCENTRATE;ORAL078053-001Feb 5, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077345-002Feb 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Pliva Hrvatska Doo
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077299-002Feb 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077977-001Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: sertraline hydrochloride

International Patent Family for Ingredient: sertraline hydrochloride

Country Document Number Estimated Expiration
Japan3792514► Subscribe
Poland348119► Subscribe
China1323202► Subscribe
TunisiaSN99190► Subscribe
Portugal1121107► Subscribe
Georgia, Republic ofP20032969► Subscribe
Guatemala199900171► Subscribe
Bulgaria105434► Subscribe
New Zealand510756► Subscribe
Gulf Cooperation Council0000175► 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:

Dow
Medtronic
Colorcon
Teva
McKesson
Baxter
AstraZeneca
Cerilliant
Julphar
Healthtrust

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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