Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
Merck
AstraZeneca
McKinsey
Express Scripts

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

SERTRALINE HYDROCHLORIDE Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

When do Sertraline Hydrochloride patents expire, and when can generic versions of Sertraline Hydrochloride launch?

Sertraline Hydrochloride is a drug marketed by Aci Healthcare Ltd, Aurobindo Pharma, Ranbaxy Labs Ltd, Accord Hlthcare, Anda Repository, Austarpharma Llc, Cadila, Chartwell Molecular, Fosun Pharma, Heritage Pharma, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Wockhardt. and is included in twenty-nine NDAs.

The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Sertraline Hydrochloride

A generic version of SERTRALINE HYDROCHLORIDE was approved as sertraline hydrochloride by AUROBINDO PHARMA on February 6th, 2007.

  Start Trial

Drug patent expirations by year for SERTRALINE HYDROCHLORIDE
Recent Clinical Trials for SERTRALINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Sao PauloPhase 2
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 2
University of North Carolina, Chapel HillPhase 4

See all SERTRALINE HYDROCHLORIDE clinical trials

Pharmacology for SERTRALINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for SERTRALINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for SERTRALINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ZOLOFT TABLET;ORAL sertraline hydrochloride 019839 2005-11-09
ZOLOFT CONCENTRATE;ORAL sertraline hydrochloride 020990 2003-12-09

US Patents and Regulatory Information for SERTRALINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077977-003 Feb 6, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma Pharms SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077864-002 Aug 10, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharma SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 076465-002 Aug 11, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Lupin SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077670-001 Feb 6, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 078626-003 Jan 31, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
Merck
AstraZeneca
McKinsey
Express Scripts

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 verification 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.