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Last Updated: September 26, 2022

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, Cadila, 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, and Viwit Pharm, 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-six 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
AbbViePhase 4
The Medical Research NetworkPhase 4
Alexandria UniversityPhase 2

See all sertraline hydrochloride clinical trials

Generic filers with tentative approvals for SERTRALINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 100MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 50MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 25MG 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.

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
Viatris ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999 AA RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Torrent Pharms SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077765-003 Feb 6, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Heritage Pharma Avet SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077663-002 Feb 6, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 019839-004 Dec 30, 1991 See Plans and Pricing See Plans and Pricing
Viatris ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-002 Dec 30, 1991 See Plans and Pricing See Plans and Pricing
Viatris ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-001 Dec 30, 1991 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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