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Last Updated: March 28, 2024

ZOLOFT Drug Patent Profile


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

Zoloft is a drug marketed by Viatris and is included in two NDAs.

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

Drug patent expirations by year for ZOLOFT
Drug Prices for ZOLOFT

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Drug Sales Revenue Trends for ZOLOFT

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Recent Clinical Trials for ZOLOFT

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

SponsorPhase
University of Texas at AustinPhase 4
Lehigh UniversityPhase 4
Mclean HospitalPhase 4

See all ZOLOFT clinical trials

Pharmacology for ZOLOFT
Anatomical Therapeutic Chemical (ATC) Classes for ZOLOFT
Paragraph IV (Patent) Challenges for ZOLOFT
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 ZOLOFT

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viatris ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-002 Dec 30, 1991 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viatris ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-005 Mar 6, 1996 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viatris ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-001 Dec 30, 1991 AB RX Yes 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 ZOLOFT

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
Viatris ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ZOLOFT

See the table below for patents covering ZOLOFT around the world.

Country Patent Number Title Estimated Expiration
Australia 5643699 ⤷  Try a Trial
European Patent Office 0429189 Utilisation de la sertraline dans la fabrication d'un médicament destiné au traitement des troubles obsessifs compulsifs (Use of Sertraline for the manufacture of a medicament for treating obsessive-compulsive disorders) ⤷  Try a Trial
Hong Kong 82284 ANTIDEPRESSANT DERIVATIVES OF CIS-4-PHENYL-1,2,3,4-TETRAHYDRO-1-NAPHTHALENAMINE AND PHARMACEUTICAL COMPOSITIONS THEREOF ⤷  Try a Trial
Hungary T58512 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZOLOFT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0030081 SPC/GB93/048 United Kingdom ⤷  Try a Trial SPC/GB93/048, EXPIRES: 20051027
0030081 93C0073 Belgium ⤷  Try a Trial PRODUCT NAME: SERTRALINI HYDROCHLORID; NAT. REG.: 241 IS 30 F 19901119; FIRST REG.: GB PL 0057/03 19901119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.