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Serving leading biopharmaceutical companies globally:

Merck
Fish and Richardson
Fuji
Mallinckrodt
UBS
Dow
Daiichi Sankyo
Novartis
Cantor Fitzgerald
Covington

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for Patent: 9,125,816

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Which drugs does patent 9,125,816 protect, and when does it expire?

Patent 9,125,816 protects ANDROGEL and is included in two NDAs.

Protection for ANDROGEL has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and nine patent family members in thirty-one countries.
Summary for Patent: 9,125,816
Title:Pharmaceutical composition and method for treating hypogonadism
Abstract: A pharmaceutical composition useful for treating hypogonadism is disclosed. The composition comprises an androgenic or anabolic steroid, a C1-C4 alcohol, a penetration enhancer such as isopropyl myristate, and water. Also disclosed is a method for treating hypogonadism utilizing the composition.
Inventor(s): Dudley; Robert E. (Kenilworth, IL), Drouin; Dominique (Verrieres le Buisson, FR)
Assignee: BESINS HEALTHCARE INC. (Herndon, VA) UNIMED PHARMACEUTICALS, LLC (Abbott Park, IL)
Application Number:13/965,499
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;

Drugs Protected by US Patent 9,125,816

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 021015-003 Sep 26, 2003 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 AB2 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-001 Feb 28, 2000 AB1 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ 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. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 9,125,816

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
2,004,092,494 ➤ Subscribe
6,503,894 Pharmaceutical composition and method for treating hypogonadism ➤ Subscribe
9,132,089 Pharmaceutical composition and method for treating hypogonadism ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 9,125,816

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Ukraine 80964 ➤ Subscribe
Ukraine 76958 ➤ Subscribe
Taiwan I339122 ➤ Subscribe
Taiwan 200412976 ➤ Subscribe
Turkey 200300776 ➤ Subscribe
Slovenia 1315502 ➤ Subscribe
Slovenia 1313482 ➤ Subscribe
Russian Federation 2303981 ➤ Subscribe
Russian Federation 2286787 ➤ Subscribe
Portugal 1322336 ➤ Subscribe
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Colorcon
Chinese Patent Office
Fish and Richardson
Novartis
Daiichi Sankyo
Teva
AstraZeneca
Covington

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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