testosterone cypionate Drug Patent Profile
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Which patents cover Testosterone Cypionate, and what generic alternatives are available?
Testosterone Cypionate is a drug marketed by Am Regent, Cipla, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Labs, Watson Pharms Inc, Wilshire Pharms Inc, Xiromed, and Azurity. and is included in sixteen NDAs. There are two patents protecting this drug.
The generic ingredient in TESTOSTERONE CYPIONATE is estradiol cypionate; testosterone cypionate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol cypionate; testosterone cypionate profile page.
DrugPatentWatch® Generic Entry Outlook for Testosterone Cypionate
Indicators of Generic Entry
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Summary for testosterone cypionate
| US Patents: | 2 |
| Applicants: | 14 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 44 |
| Clinical Trials: | 30 |
| Patent Applications: | 3,063 |
| Drug Prices: | Drug price information for testosterone cypionate |
| DailyMed Link: | testosterone cypionate at DailyMed |
Recent Clinical Trials for testosterone cypionate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
| Dendreon | Phase 2 |
| Yale University | Phase 2 |
Pharmacology for testosterone cypionate
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for testosterone cypionate
US Patents and Regulatory Information for testosterone cypionate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 207742-001 | Jun 16, 2017 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Pharms Inc | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 086030-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE | estradiol cypionate; testosterone cypionate | INJECTABLE;INJECTION | 085603-001 | Mar 13, 1986 | 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 |
