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Last Updated: March 19, 2024

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

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Drug patent expirations by year for TESTOSTERONE
Drug Prices for TESTOSTERONE

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Drug Sales Revenue Trends for TESTOSTERONE

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Recent Clinical Trials for TESTOSTERONE

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SponsorPhase
Myovant Sciences GmbHPhase 2
Brown UniversityPhase 1
Cures Within ReachPhase 1

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Pharmacology for TESTOSTERONE
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories 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 080743-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 211817-002 Oct 20, 2023 AO RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla TESTOSTERONE testosterone SOLUTION, METERED;TRANSDERMAL 209533-001 Jan 29, 2018 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Ltd TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 201720-001 Jun 3, 2013 AO RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE estradiol cypionate; testosterone cypionate INJECTABLE;INJECTION 085603-001 Mar 13, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Us TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 040530-001 Jan 31, 2005 AO RX No No ⤷  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

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

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