DEXAMETHASONE ACETATE - Generic Drug Details
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What are the generic drug sources for dexamethasone acetate and what is the scope of freedom to operate?
Dexamethasone acetate
is the generic ingredient in two branded drugs marketed by Merck, Watson Labs, and Watson Labs Teva, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for dexamethasone acetate.
Summary for DEXAMETHASONE ACETATE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 82 |
| Patent Applications: | 4,131 |
| DailyMed Link: | DEXAMETHASONE ACETATE at DailyMed |
Recent Clinical Trials for DEXAMETHASONE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme LLC | Phase 1 |
| Orion Corporation, Orion Pharma | Phase 1 |
| Assiut University | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for DEXAMETHASONE ACETATE
US Patents and Regulatory Information for DEXAMETHASONE ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | DEXAMETHASONE ACETATE | dexamethasone acetate | INJECTABLE;INJECTION | 084315-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs Teva | DEXAMETHASONE ACETATE | dexamethasone acetate | INJECTABLE;INJECTION | 087711-001 | May 24, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck | DECADRON-LA | dexamethasone acetate | INJECTABLE;INJECTION | 016675-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
