Nandrolone decanoate - Generic Drug Details
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What are the generic drug sources for nandrolone decanoate and what is the scope of freedom to operate?
Nandrolone decanoate
is the generic ingredient in two branded drugs marketed by Woodward Specl, Abraxis Pharm, Am Regent, Epic Pharma Llc, and Watson Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for nandrolone decanoate.
Summary for nandrolone decanoate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 5 |
| NDAs: | 11 |
| Drug Master File Entries: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 11 |
| Patent Applications: | 2,035 |
| DailyMed Link: | nandrolone decanoate at DailyMed |
Recent Clinical Trials for nandrolone decanoate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical Research Agency, Poland | Phase 2 |
| National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland | Phase 2 |
| King Edward Medical University | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for nandrolone decanoate
US Patents and Regulatory Information for nandrolone decanoate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | NANDROLONE DECANOATE | nandrolone decanoate | INJECTABLE;INJECTION | 088128-001 | Dec 5, 1983 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | NANDROLONE DECANOATE | nandrolone decanoate | INJECTABLE;INJECTION | 087599-001 | Oct 6, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Woodward Specl | DECA-DURABOLIN | nandrolone decanoate | INJECTABLE;INJECTION | 013132-001 | Jun 12, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | NANDROLONE DECANOATE | nandrolone decanoate | INJECTABLE;INJECTION | 086598-001 | Jan 13, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Epic Pharma Llc | NANDROLONE DECANOATE | nandrolone decanoate | INJECTABLE;INJECTION | 087519-001 | Sep 28, 1983 | DISCN | 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 |
