FDA Orange Book · active-ingredient family
Docosanol
Docosanol is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ABREVA · NDA 020941
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ABREVARLD | HALEON US HOLDINGS | NDA 020941 | — | Jul 25, 2000 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOCOSANOL | DR REDDYS | ANDA 215505 | — | Oct 23, 2025 | |
| DOCOSANOL | DR REDDYS | ANDA 214613 | — | Oct 03, 2025 | |
| DOCOSANOL | AUROBINDO PHARMA LTD | ANDA 217090 | — | Mar 01, 2024 | |
| DOCOSANOL | SUN PHARMA CANADA | ANDA 214454 | — | Oct 26, 2023 | |
| DOCOSANOL | P AND L DEVELOPMENT | ANDA 212385 | — | Oct 07, 2022 | |
| DOCOSANOL | ALEMBIC | ANDA 215839 | — | May 03, 2022 | |
| DOCOSANOL | P AND L | ANDA 208754 | — | Nov 19, 2018 |
Listed patents
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.
Docosanol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
