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Last Updated: October 1, 2022

TESTIM Drug Patent Profile


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When do Testim patents expire, and what generic alternatives are available?

Testim is a drug marketed by Auxilium Pharms Llc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in twenty-nine countries.

The generic ingredient in TESTIM 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 Testim

A generic version of TESTIM was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.

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Drug patent expirations by year for TESTIM
Drug Prices for TESTIM

See drug prices for TESTIM

Drug Sales Revenue Trends for TESTIM

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Recent Clinical Trials for TESTIM

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

SponsorPhase
Endo PharmaceuticalsPhase 4
Instituto de Investigacion Sanitaria La FePhase 3
Marianne AndersenPhase 4

See all TESTIM clinical trials

Pharmacology for TESTIM
Drug Class Androgen
Mechanism of ActionAndrogen Receptor Agonists
Paragraph IV (Patent) Challenges for TESTIM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TESTIM Gel testosterone 1% 021454 1 2008-08-21

US Patents and Regulatory Information for TESTIM

TESTIM is protected by ten US patents.

Patents protecting TESTIM

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTRATION OF TESTOSTERONE

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTRATION OF TESTOSTERONE

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTRATION OF TESTOSTERONE

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTRATION OF TESTOSTERONE

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTRATION OF TESTOSTERONE

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTRATION OF TESTOSTERONE

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTRATION OF TESTOSTERONE

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTRATION OF TESTOSTERONE

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTRATION OF TESTOSTERONE

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 AB2 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 AB2 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 AB2 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 AB2 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 AB2 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 AB2 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 TESTIM

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 ChilcottĀ  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 TESTIM

See the table below for patents covering TESTIM around the world.

Country Patent Number Title Estimated Expiration
Canada 1312281 ADMINISTRATION TRANSDERMIQUE DE MEDICAMENTS (TRANSDERMAL DELIVERY OF DRUGS) See Plans and Pricing
Canada 2470200 COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) See Plans and Pricing
Denmark 403187 See Plans and Pricing
South Korea 20090079266 PHARMACEUTICAL COMPOSITION See Plans and Pricing
Norway 335864 See Plans and Pricing
Finland 873328 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TESTIM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8703473 91289 Luxembourg See Plans and Pricing PRODUCT NAME: TESTIM; REGISRATION NO 1768/92
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck
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McKesson
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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.