TESTOSTERONE ENANTHATE Drug Patent Profile
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Which patents cover Testosterone Enanthate, and what generic alternatives are available?
Testosterone Enanthate is a drug marketed by Eugia Pharma, Hikma Farmaceutica, Nexus, Rising, Watson Labs, and Watson Pharms Inc. and is included in nine NDAs.
The generic ingredient in TESTOSTERONE ENANTHATE is estradiol valerate; testosterone enanthate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol valerate; testosterone enanthate profile page.
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Summary for TESTOSTERONE ENANTHATE
Recent Clinical Trials for TESTOSTERONE ENANTHATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The George Institute | PHASE2 |
| HMRI | PHASE2 |
| Australian and New Zealand Urogenital and Prostate Cancer Trials Group | PHASE2 |
Pharmacology for TESTOSTERONE ENANTHATE
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for TESTOSTERONE ENANTHATE
US Patents and Regulatory Information for TESTOSTERONE ENANTHATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eugia Pharma | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 212659-001 | Feb 28, 2024 | AO | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Watson Labs | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 083667-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Rising | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 040647-001 | Oct 5, 2009 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Watson Pharms Inc | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 085598-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma Farmaceutica | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 091120-001 | Sep 18, 2012 | AO | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Nexus | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 040575-001 | Jun 14, 2006 | AO | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
