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Last Updated: March 28, 2024

Sertraline hydrochloride - Generic Drug Details


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

Sertraline hydrochloride is the generic ingredient in two branded drugs marketed by Almatica, ACI, Aurobindo Pharma, Ranbaxy Labs Ltd, Viatris, Accord Hlthcare, Anda Repository, Ascent Pharms Inc, Chartwell Molecular, Fosun Pharma, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Reyoung, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Zydus, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for sertraline hydrochloride
Recent Clinical Trials for sertraline hydrochloride

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

SponsorPhase
Dr. Inge WinterPhase 4
University of Texas at AustinPhase 4
Westfälische Wilhelms-Universität MünsterPhase 4

See all sertraline hydrochloride clinical trials

Generic filers with tentative approvals for SERTRALINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 50MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 25MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 100MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for sertraline hydrochloride
Medical Subject Heading (MeSH) Categories for sertraline hydrochloride
Paragraph IV (Patent) Challenges for SERTRALINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZOLOFT Tablets sertraline hydrochloride 150 mg and 200 mg 019839 1 2005-11-09
ZOLOFT Oral Concentrate sertraline hydrochloride 20 mg/mL 020990 1 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
Granules SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 078403-003 Jan 8, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Torrent Pharms SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077765-002 Feb 6, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fosun Pharma SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077713-002 Feb 6, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for sertraline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viatris ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-001 Dec 30, 1991 ⤷  Try a Trial ⤷  Try a Trial
Viatris ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-003 Dec 30, 1991 ⤷  Try a Trial ⤷  Try a Trial
Viatris ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-005 Mar 6, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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