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, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Ani Pharms, Strides Pharma, Dr Reddys, Watson Labs, Apotex, Cipla, Lupin Ltd, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Azurity, Nexus, Bel Mar, Elkins Sinn, and Lilly. and is included in sixty NDAs. There are two patents protecting this drug.
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.
DrugPatentWatch® Generic Entry Outlook for Testosterone
Annual sales in 2021 were $306mm indicating the motivation for generic entry (peak sales were $1.3bn in 2019).
There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for TESTOSTERONE?
- What are the global sales for TESTOSTERONE?
- What is Average Wholesale Price for TESTOSTERONE?
Summary for TESTOSTERONE
| US Patents: | 0 |
| Applicants: | 31 |
| NDAs: | 60 |
| Finished Product Suppliers / Packagers: | 14 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 1,045 |
| Patent Applications: | 4,302 |
| 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 |
|---|---|
| Morten Hostrup, PhD | N/A |
| VA Office of Research and Development | Early Phase 1 |
| Jonsson Comprehensive Cancer Center | Phase 2 |
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 | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AXIRON | Topical Solution | testosterone | 30 mg/1.5 mL | 022504 | 1 | 2013-01-29 |
| FORTESTA | Gel | testosterone | 10 mg/actuation | 021463 | 1 | 2012-08-14 |
| TESTIM | Gel | testosterone | 1% | 021454 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bel Mar | TESTOSTERONE PROPIONATE | testosterone propionate | INJECTABLE;INJECTION | 080741-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eugia Pharma | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 211817-001 | Oct 20, 2023 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | TESTOSTERONE | testosterone | SOLUTION, METERED;TRANSDERMAL | 209181-001 | Nov 25, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 040615-002 | Aug 10, 2006 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Azurity | TESTOSTERONE CYPIONATE | testosterone cypionate | SOLUTION;INTRAMUSCULAR | 216318-001 | Jun 2, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for TESTOSTERONE
| 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 |
