➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Medtronic
Boehringer Ingelheim
Colorcon
McKinsey

Last Updated: April 22, 2021

DrugPatentWatch Database Preview

TESTOSTERONE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for testosterone and what is the scope of freedom to operate?

Testosterone is the generic ingredient in twenty branded drugs marketed by Allergan, Alza, Acerus, Abbvie, Endo Pharms, Actavis Labs Ut Inc, Amneal, Dr Reddys, Lupin, Perrigo Israel, Twi Pharms, Xiromed, Upsher Smith Labs, Auxilium Pharms Llc, Ani Pharms Inc, Par Pharm, Perrigo Uk Finco, Watson Labs, Auxilium Pharms Inc, Eli Lilly And Co, Apotex, Cipla, Lupin Ltd, Pharmacia And Upjohn, Am Regent, Hikma Farmaceutica, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Wilshire Pharms Inc, Nexus Pharms, Antares Pharma Inc, Bel Mar, Elkins Sinn, Lilly, Clarus, and Endo Pharms Inc, and is included in sixty-five NDAs. There are fifty-five patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Testosterone has two hundred and ninety-nine patent family members in forty-four countries.

There are sixty-nine drug master file entries for testosterone. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for TESTOSTERONE

See drug prices for TESTOSTERONE

Drug Sales Revenue Trends for TESTOSTERONE

See drug sales revenues for TESTOSTERONE

Recent Clinical Trials for TESTOSTERONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Western University, CanadaN/A
Propella TherapeuticsPhase 1/Phase 2
Erasmus Medical CenterPhase 3

See all TESTOSTERONE clinical trials

Generic filers with tentative approvals for TESTOSTERONE
Applicant Application No. Strength Dosage Form
  Get Started Free  Get Started Free30MG/1.5ML ACTUATIONSOLUTION, METERED;TRANSDERMAL
  Get Started Free  Get Started Free750MG/3ML (250MG/ML)INJECTABLE;INTRAMUSCULAR
  Get Started Free  Get Started FreeUNKNOWNUNKNOWN

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 NDA Submissiondate
AXIRON SOLUTION, METERED;TRANSDERMAL testosterone 022504 2013-01-29
FORTESTA GEL, METERED;TRANSDERMAL testosterone 021463 2012-08-14
TESTIM GEL;TRANSDERMAL testosterone 021454 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
Twi Pharms TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 209390-001 Sep 23, 2019 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Lupin TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 208560-001 Apr 10, 2019 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 021015-003 Sep 26, 2003 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
Watson Labs TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 085490-002 Approved Prior to Jan 1, 1982 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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 TESTOSTERONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-001 Sep 29, 1995   Get Started Free   Get Started Free
Allergan ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-001 Sep 29, 1995   Get Started Free   Get Started Free
Alza TESTODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 019762-002 Oct 12, 1993   Get Started Free   Get Started Free
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Colorcon
Express Scripts
Johnson and Johnson
AstraZeneca

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.