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, Aurobindo Pharma Ltd, P And L, P And L Development, and Taro, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for DOCOSANOL

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	1
Patent Applications:	9,710
Drug Prices:	Drug price trends for DOCOSANOL
What excipients (inactive ingredients) are in DOCOSANOL?	DOCOSANOL excipients list
DailyMed Link:	DOCOSANOL at DailyMed

See drug prices for DOCOSANOL

Recent Clinical Trials for DOCOSANOL

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

Sponsor	Phase
Laboratoire Boreaderme Inc.	Phase 2
Ecogene 21	Phase 2

See all DOCOSANOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DOCOSANOL

D06BB	Antivirals
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for DOCOSANOL

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941-001	Jul 25, 2000		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
P And L Development	DOCOSANOL	docosanol	CREAM;TOPICAL	212385-001	Oct 7, 2022		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
P And L	DOCOSANOL	docosanol	CREAM;TOPICAL	208754-001	Nov 19, 2018		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	DOCOSANOL	docosanol	CREAM;TOPICAL	217090-001	Mar 1, 2024		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 DOCOSANOL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941-001	Jul 25, 2000	⤷ Sign Up	⤷ Sign Up
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941-001	Jul 25, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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