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Last Updated: September 29, 2023

TOLAK Drug Patent Profile


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

Tolak is a drug marketed by Hill Dermaceuticals and is included in one NDA. There is one patent protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in TOLAK is fluorouracil. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tolak

A generic version of TOLAK was approved as fluorouracil by FRESENIUS KABI USA on September 30th, 1998.

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US Patents and Regulatory Information for TOLAK

TOLAK is protected by one US patents.

Patents protecting TOLAK

Topical skin care composition containing refined peanut oil
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Hill Dermaceuticals TOLAK fluorouracil CREAM;TOPICAL 022259-001 Sep 18, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for TOLAK

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

Country Patent Number Title Estimated Expiration
European Patent Office 1696868 COMPOSITION TOPIQUE DE SOINS DE LA PEAU CONTENANT DE L'HUILE DE CACAHUETES RAFFINEE (TOPICAL SKIN CARE COMPOSITION CONTAINING REFINED PEANUT OIL) ⤷  Try a Trial
Canada 2541373 COMPOSITION TOPIQUE DE SOINS DE LA PEAU CONTENANT DE L'HUILEDE CACAHUETES RAFFINEE (TOPICAL SKIN CARE COMPOSITION CONTAINING REFINED PEANUT OIL) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005009406 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Moodys
McKinsey
Express Scripts
AstraZeneca

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