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, Dash Pharms, Lupin Ltd, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Slayback Pharma Llc, Nexus, Bel Mar, Elkins Sinn, and Lilly. and is included in fifty-nine 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
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
Summary for TESTOSTERONE
US Patents: | 0 |
Applicants: | 32 |
NDAs: | 59 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 1,020 |
Patent Applications: | 6,784 |
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 |
Recent Clinical Trials for TESTOSTERONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Myovant Sciences GmbH | Phase 2 |
Brown University | Phase 1 |
Cures Within Reach | Phase 1 |
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
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 |