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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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