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Last Updated: March 18, 2024

Docosanol - Generic Drug Details


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What are the generic sources for docosanol and what is the scope of freedom to operate?

Docosanol is the generic ingredient in two branded drugs marketed by Haleon Us Holdings, Alembic, Encube, P And L, and Taro, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for docosanol. Thirty-three suppliers are listed for this compound.

Drug Prices for docosanol

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Recent Clinical Trials for docosanol

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

SponsorPhase
Laboratoire Boreaderme Inc.Phase 2
Ecogene 21Phase 2

See all docosanol clinical trials

US Patents and Regulatory Information for docosanol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
P And L DOCOSANOL docosanol CREAM;TOPICAL 208754-001 Nov 19, 2018 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Encube DOCOSANOL docosanol CREAM;TOPICAL 212385-001 Oct 7, 2022 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro DOCOSANOL docosanol CREAM;TOPICAL 214454-001 Oct 26, 2023 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings ABREVA docosanol CREAM;TOPICAL 020941-001 Jul 25, 2000 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic DOCOSANOL docosanol CREAM;TOPICAL 215839-001 May 3, 2022 OTC No 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

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