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Last Updated: July 6, 2020

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TESTIM Drug 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. Nineteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

US ANDA 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

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Drug Sales Revenue Trends for TESTIM

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Recent Clinical Trials for TESTIM

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

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2/Phase 3
University of WashingtonPhase 2/Phase 3
Repros Therapeutics Inc.Phase 2

See all TESTIM clinical trials

Pharmacology for TESTIM
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Paragraph IV (Patent) Challenges for TESTIM
Tradename Dosage Ingredient NDA Submissiondate
TESTIM GEL;TRANSDERMAL testosterone 021454 2008-08-21

US Patents and Regulatory Information for TESTIM

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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Merck
Mallinckrodt
McKesson
Baxter

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