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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Johnson and Johnson
UBS
Harvard Business School
Medtronic
Federal Trade Commission
Merck
US Department of Justice
Moodys

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,503,894

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Which drugs does patent 6,503,894 protect, and when does it expire?


Patent 6,503,894 protects ANDROGEL and is included in two NDAs. There have been three Paragraph IV challenges on Androgel.

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: 6,503,894

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), Kottayil; S. George (Long Grove, IL), Palatchi; Olivier (L'Hay les Roses, FR)
Assignee: Unimed Pharmaceuticals, Inc. (Marietta, GA) Laboratories Besins Iscovesco (Herndon, VA)
Application Number:09/651,777
Patent Claim Types:
see list of patent claims
Composition; Formulation; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Abbvie
ANDROGEL
testosterone
GEL, METERED;TRANSDERMAL022309-001Apr 29, 2011ABRXYesYes► Subscribe► SubscribeY
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-002Sep 7, 2012AB2RXYesNo► Subscribe► SubscribeY
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL022309-003Sep 7, 2012AB2RXYesYes► Subscribe► SubscribeY
Abbvie
ANDROGEL
testosterone
GEL, METERED;TRANSDERMAL021015-003Sep 26, 2003ABRXYesYes► Subscribe► SubscribeY
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL021015-001Feb 28, 2000AB1RXYesNo► Subscribe► SubscribeY
Abbvie
ANDROGEL
testosterone
GEL;TRANSDERMAL021015-002Feb 28, 2000AB1RXYesYes► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 6,503,894

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
9,132,089Pharmaceutical composition and method for treating hypogonadism► Subscribe
9,125,816Pharmaceutical composition and method for treating hypogonadism► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 6,503,894

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
China1652793► Subscribe
China100544725► Subscribe
China101077350► Subscribe
China101081203► Subscribe
Cyprus1110085► Subscribe
Cyprus1110907► Subscribe
Germany60138553► Subscribe
Germany60141587► Subscribe
Denmark1313482► Subscribe
Denmark1315502► 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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Federal Trade Commission
Farmers Insurance
Dow
Colorcon
Julphar
Cipla
UBS
McKesson
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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