FORTESTA Drug Patent 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. Twenty-one suppliers are listed for this compound. Additional details are available on the testosterone profile page.
DrugPatentWatch® 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 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 66 |
Clinical Trials: | 3 |
Patent Applications: | 4,353 |
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 |
---|---|
Endo Pharmaceuticals | Phase 4 |
Johns Hopkins University | Phase 4 |
Endo Pharmaceuticals | Phase 3 |
Pharmacology for FORTESTA
Drug Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for FORTESTA
Paragraph IV (Patent) Challenges for FORTESTA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FORTESTA | Gel | testosterone | 10 mg/actuation | 021463 | 1 | 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Endo Pharms | FORTESTA | testosterone | GEL, METERED;TRANSDERMAL | 021463-001 | Dec 29, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for FORTESTA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Warner Chilcott UK Ltd. | Intrinsa | testosterone | EMEA/H/C/000634 Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy. |
Withdrawn | no | no | no | 2006-07-28 | |
Warner Chilcott Deutschland GmbH | Livensa | testosterone | EMEA/H/C/000630 Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy. |
Withdrawn | no | no | no | 2006-07-28 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for FORTESTA
See the table below for patents covering FORTESTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1030668 | ⤷ Try a Trial | |
Brazil | 9814014 | Composição para aplicação tópica tendo propriedades de melhora da penetração | ⤷ Try a Trial |
Portugal | 1510213 | ⤷ Try a Trial | |
Australia | 747041 | ⤷ Try a Trial | |
Spain | 2318233 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |