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Serving 500+ biopharmaceutical companies globally:

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Generated: September 25, 2017

DrugPatentWatch Database Preview

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, Frontida Biopharm, 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 forty-nine patent family members in forty-five countries.

There are twenty-two drug master file entries for sertraline hydrochloride. Sixty suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: sertraline hydrochloride

Tradenames:2
Patents:2
Applicants:28
NDAs:31
Drug Master File Entries: see list22
Suppliers / Packagers: see list60
Bulk Api Vendors: see list68
Clinical Trials: see list2,502
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
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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;ORAL077670-003Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Aci Healthcare Ltd
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL076881-002Feb 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077977-001Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Accord Hlthcare
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL202825-003Nov 7, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL078626-001Jan 31, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077765-001Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL076465-002Aug 11, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Aci Healthcare Ltd
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL076881-003Feb 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077106-003Feb 6, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL076442-003Apr 30, 2007DISCNNoNo► 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
Spain2209490► Subscribe
Ukraine72743► Subscribe
South Korea100417200► Subscribe
Australia766202► Subscribe
Hungary0104470► Subscribe
Gulf Cooperation Council0000175► Subscribe
Peru11082000► Subscribe
New Zealand510756► Subscribe
CroatiaP20010263► Subscribe
Hong Kong1040199► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
McKinsey
Cipla
Accenture
Medtronic
Chinese Patent Office
Express Scripts
Daiichi Sankyo
Argus Health
Covington

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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