FDA Orange Book · active-ingredient family
Docosanol
Docosanol: 1 brand, 7 generics; first approved Jul 25, 2000; generic available.
Generic available
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- HALEON US HOLDINGSNDA 0209412000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% CREAM TOPICAL OTC —
Generic (ANDA) products (7)
Abbreviated applications
- DOCOSANOLDR REDDYSANDA 2155052025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% CREAM TOPICAL OTC — - DOCOSANOLDR REDDYSANDA 2146132025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% CREAM TOPICAL OTC — - DOCOSANOLAUROBINDO PHARMA LTDANDA 2170902024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% CREAM TOPICAL OTC — - DOCOSANOLSUN PHARMA CANADAANDA 2144542023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% CREAM TOPICAL OTC — - DOCOSANOLP AND L DEVELOPMENTANDA 2123852022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% CREAM TOPICAL OTC — - DOCOSANOLALEMBICANDA 2158392022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% CREAM TOPICAL OTC — - DOCOSANOLP AND LANDA 2087542018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% CREAM TOPICAL OTC —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
26 yr 5 mo ago
Most recent approval
10 mo ago
Approvals span 2000–2025 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Docosanol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
