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Last Updated: August 7, 2020

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TOLAK Drug 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. Eighteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

US ANDA 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

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   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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