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Last Updated: August 12, 2020

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ZOLOFT Drug Profile

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Which patents cover Zoloft, and what generic alternatives are available?

Zoloft is a drug marketed by Upjohn and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two patent family members in forty-five countries.

The generic ingredient in ZOLOFT 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.

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

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SponsorPhase
Alto NeurosciencePhase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 4
Middlebury CollegePhase 4

See all ZOLOFT clinical trials

Pharmacology for ZOLOFT
Paragraph IV (Patent) Challenges for ZOLOFT
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 ZOLOFT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upjohn ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-004 Dec 30, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-001 Dec 30, 1991 AB RX Yes No   Start Trial   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-005 Mar 6, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-003 Dec 30, 1991 DISCN Yes 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

Expired US Patents for ZOLOFT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-002 Dec 30, 1991   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-003 Dec 30, 1991   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-003 Dec 30, 1991   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-001 Dec 30, 1991   Start Trial   Start Trial
Upjohn ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-005 Mar 6, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZOLOFT

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

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