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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Baxter
Colorcon
Novartis
Deloitte
Citi
McKinsey
US Army
Teva
Johnson and Johnson

Generated: January 17, 2018

DrugPatentWatch Database Preview

Testosterone - Generic Drug Details

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

Testosterone
is the generic ingredient in eighteen branded drugs marketed by Allergan Sales Llc, Alza, Aytu Bioscience Inc, Abbvie, Endo Pharms, Actavis Labs Ut Inc, Perrigo Israel, Upsher-smith Labs, Auxilium Pharms Llc, Ani Pharms Inc, Par Pharm, Perrigo Uk Finco, Watson Labs, Auxilium Pharms Inc, Eli Lilly And Co, Lupin Ltd, Pharmacia And Upjohn, Hikma Farmaceutica, Luitpold Pharms Inc, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Bel Mar, Elkins Sinn, Lilly, and Endo Pharms Inc, and is included in fifty-three NDAs. There are forty-six patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Testosterone has four hundred and fifteen patent family members in forty-eight countries.

There are sixty-two drug master file entries for testosterone. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for testosterone
Pharmacology for testosterone
Ingredient-typeAndrostanes
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for testosterone
Tentative approvals for TESTOSTERONE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe30MG/1.5MLSOLUTION;TOPICAL

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
Ani Pharms Inc TESTOSTERONE testosterone GEL;TRANSDERMAL 202763-002 Feb 14, 2012 BX RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Watson Labs TESTOSTERONE CYPIONATE testosterone cypionate INJECTABLE;INJECTION 086029-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm TESTOSTERONE testosterone GEL;TRANSDERMAL 076744-001 May 23, 2007 AB1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Endo Pharms DELATESTRYL testosterone enanthate INJECTABLE;INJECTION 009165-003 Approved Prior to Jan 1, 1982 AO RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-001 Feb 28, 2000 AB1 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 AB2 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-002 Feb 28, 2000 AB1 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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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Expired US Patents for testosterone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ➤ Subscribe ➤ Subscribe
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-001 Sep 29, 1995 ➤ Subscribe ➤ Subscribe
Auxilium Pharms Llc STRIANT testosterone TABLET, EXTENDED RELEASE;BUCCAL 021543-001 Jun 19, 2003 ➤ Subscribe ➤ Subscribe
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997 ➤ Subscribe ➤ Subscribe
Alza TESTODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 019762-002 Oct 12, 1993 ➤ Subscribe ➤ Subscribe
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-001 Sep 29, 1995 ➤ Subscribe ➤ Subscribe
Auxilium Pharms Llc TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 ➤ Subscribe ➤ Subscribe
Alza TESTODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 019762-002 Oct 12, 1993 ➤ Subscribe ➤ Subscribe
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997 ➤ Subscribe ➤ Subscribe
Alza TESTODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 019762-001 Oct 12, 1993 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for testosterone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,126,959 Pharmaceutical composition for treating dysmenorrhea and premature labor ➤ Subscribe
7,153,845 Bioadhesive progressive hydration tablets ➤ Subscribe
7,157,097 Penetration enhancing and irritation reducing systems ➤ Subscribe
2,014,073,618 ➤ Subscribe
7,438,203 Dermal penetration enhancers and drug delivery systems involving same ➤ Subscribe
6,916,487 Transdermal delivery of antiemetics ➤ Subscribe
2,004,092,494 ➤ Subscribe
6,964,777 Transdermal delivery of antianxiety agents ➤ Subscribe
8,357,393 Transdermal delivery rate control using amorphous pharmaceutical compositions ➤ Subscribe
8,177,449 Spreading implement ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for testosterone

Supplementary Protection Certificates for testosterone

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00523 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
972 Luxembourg ➤ Subscribe 91972, EXPIRES: 20220219
2012 00012 Denmark ➤ Subscribe
00522 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2012 00010 Denmark ➤ Subscribe
971 Luxembourg ➤ Subscribe 91971, EXPIRES: 20220219
00521 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
2012 00011 Denmark ➤ Subscribe
973 Luxembourg ➤ Subscribe 91973, EXPIRES: 20220219
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Moodys
Deloitte
Merck
Johnson and Johnson
Chubb
Julphar
Daiichi Sankyo

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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