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TESTOSTERONE Drug Patent Profile
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When do Testosterone patents expire, and when can generic versions of Testosterone launch?
Testosterone is a drug marketed by Actavis Labs Ut Inc, Aleor Dermaceuticals, Amneal, Dr Reddys, Lupin, Perrigo Israel, Twi Pharms, Xiromed, Ani Pharms, Padagis Israel, Par Pharm, Watson Labs, Apotex, Cipla, Dash Pharms, Lupin Ltd, Am Regent, Hikma, Hikma Farmaceutica, Mylan Institutional, Padagis Us, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Nexus Pharms, Bel Mar, Elkins Sinn, and Lilly. and is included in fifty-four NDAs.
The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-nine drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.
Summary for TESTOSTERONE
| US Patents: | 0 |
| Applicants: | 29 |
| NDAs: | 54 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| Clinical Trials: | 945 |
| Patent Applications: | 4,186 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TESTOSTERONE |
| Drug Sales Revenues: | Drug sales revenues for TESTOSTERONE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TESTOSTERONE |
| What excipients (inactive ingredients) are in TESTOSTERONE? | TESTOSTERONE excipients list |
| DailyMed Link: | TESTOSTERONE at DailyMed |
See drug prices for TESTOSTERONE
Recent Clinical Trials for TESTOSTERONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Utah | Phase 2 |
| Region Jönköping County | Phase 3 |
| Stockholm South General Hospital | Phase 3 |
Pharmacology for TESTOSTERONE
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for TESTOSTERONE
Anatomical Therapeutic Chemical (ATC) Classes for TESTOSTERONE
Paragraph IV (Patent) Challenges for TESTOSTERONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AXIRON | SOLUTION, METERED;TRANSDERMAL | testosterone | 022504 | 2013-01-29 |
| FORTESTA | GEL, METERED;TRANSDERMAL | testosterone | 021463 | 2012-08-14 |
| TESTIM | GEL;TRANSDERMAL | testosterone | 021454 | 2008-08-21 |
US Patents and Regulatory Information for TESTOSTERONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | TESTOSTERONE PROPIONATE | testosterone propionate | INJECTABLE;INJECTION | 083595-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Mylan Institutional | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 040652-001 | Dec 11, 2006 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Dash Pharms | TESTOSTERONE | testosterone | SOLUTION, METERED;TRANSDERMAL | 212301-001 | Jan 11, 2021 | AT | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Watson Labs | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 084401-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Watson Labs | TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE | estradiol valerate; testosterone enanthate | INJECTABLE;INJECTION | 085865-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Sun Pharm Inds Ltd | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 201720-001 | Jun 3, 2013 | AO | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
