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FORTESTA Drug Profile
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When do Fortesta patents expire, and what generic alternatives are available?
Fortesta is a drug marketed by Endo Pharms and is included in one NDA.
The generic ingredient in FORTESTA is testosterone. There are sixty-nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
US ANDA Litigation and Generic Entry Outlook for Fortesta
A generic version of FORTESTA was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.
Summary for FORTESTA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 61 |
Clinical Trials: | 3 |
Patent Applications: | 4,180 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FORTESTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FORTESTA |
What excipients (inactive ingredients) are in FORTESTA? | FORTESTA excipients list |
DailyMed Link: | FORTESTA at DailyMed |



Recent Clinical Trials for FORTESTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Phase 4 |
Endo Pharmaceuticals | Phase 4 |
Endo Pharmaceuticals | Phase 3 |
Pharmacology for FORTESTA
Drug Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Paragraph IV (Patent) Challenges for FORTESTA
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
FORTESTA | GEL, METERED;TRANSDERMAL | testosterone | 021463 | 2012-08-14 |
US Patents and Regulatory Information for FORTESTA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Endo Pharms | FORTESTA | testosterone | GEL, METERED;TRANSDERMAL | 021463-001 | Dec 29, 2010 | AB | RX | Yes | Yes | 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 |
Expired US Patents for FORTESTA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Endo Pharms | FORTESTA | testosterone | GEL, METERED;TRANSDERMAL | 021463-001 | Dec 29, 2010 | Start Trial | Start Trial |
Endo Pharms | FORTESTA | testosterone | GEL, METERED;TRANSDERMAL | 021463-001 | Dec 29, 2010 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FORTESTA
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 4139860 | Start Trial |
China | 1285749 | Start Trial |
Japan | 2005047932 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |