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 |
Recent Clinical Trials for DOCOSANOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratoire Boreaderme Inc. | Phase 2 |
| Ecogene 21 | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for DOCOSANOL
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Taro | DOCOSANOL | docosanol | CREAM;TOPICAL | 214454-001 | Oct 26, 2023 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alembic | DOCOSANOL | docosanol | CREAM;TOPICAL | 215839-001 | May 3, 2022 | 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 | ||||
| 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 | ||||
| >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
| 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 |
