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TESTIM Drug Profile

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Which patents cover Testim, and what substitute generic drugs are available?

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

This drug has forty-three patent family members in twenty-eight countries.

The generic ingredient in TESTIM is testosterone. There are sixty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the testosterone profile page.

Summary for Tradename: TESTIM

Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Bulk Api Vendors: see list53
Clinical Trials: see list13
Patent Applications: see list19,713
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TESTIM at DailyMed

Pharmacology for Tradename: TESTIM

Ingredient-typeAndrostanes
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Auxilium Pharms
TESTIM
testosterone
GEL;TRANSDERMAL021454-001Oct 31, 2002RXYesYes7,320,968► Subscribe ► Subscribe
Auxilium Pharms
TESTIM
testosterone
GEL;TRANSDERMAL021454-001Oct 31, 2002RXYesYes7,608,610► Subscribe ► Subscribe
Auxilium Pharms
TESTIM
testosterone
GEL;TRANSDERMAL021454-001Oct 31, 2002RXYesYes7,608,607► Subscribe ► Subscribe
Auxilium Pharms
TESTIM
testosterone
GEL;TRANSDERMAL021454-001Oct 31, 2002RXYesYes7,935,690► Subscribe ► Subscribe
Auxilium Pharms
TESTIM
testosterone
GEL;TRANSDERMAL021454-001Oct 31, 2002RXYesYes7,608,605► Subscribe ► Subscribe
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Expired Patents for Tradename: TESTIM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Auxilium Pharms
TESTIM
testosterone
GEL;TRANSDERMAL021454-001Oct 31, 20025,023,252► Subscribe
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Paragraph IV activity for: TESTIM

Drugname Dosage Strength RLD Submissiondate
testosteroneGel1%Testim8/21/2008

International Patent Family for Tradename: TESTIM

Country Document Number Estimated Expiration
Spain2292964► Subscribe
Cyprus1109005► Subscribe
Norway335864► Subscribe
South Korea20050011753► Subscribe
Taiwan200408397► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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