BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Accenture
Express Scripts
Cipla
QuintilesIMS
Argus Health
Medtronic
Farmers Insurance
Citi
Teva
Cantor Fitzgerald

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,338,395

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Which drugs does patent 8,338,395 protect, and when does it expire?

Patent 8,338,395 protects AVEED and is included in one NDA.

This patent has forty-seven patent family members in thirty-seven countries.
Summary for Patent: 8,338,395
Title:Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Abstract: Described are methods for providing prolonged physiologically acceptable steady state serum testosterone levels in a patient deficient in endogenous testosterone levels, methods for male contraception and methods for treating a disease or symptom associated with deficient endogenous levels of testosterone in a man, by intramuscularly administering testosterone esters in a vehicle.
Inventor(s): Hubler; Doris (Jena, DE), Fricke; Sabine (Jena, DE), Ingwersen; Jan-Peter (Berlin, DE), Kuhnz; Wilheim (Berlin, DE)
Assignee: Bayer Intellectual Property GmbH (Monheim, DE)
Application Number:12/391,655
Patent Claim Types:
see list of patent claims
Use; Composition;

Drugs Protected by US Patent 8,338,395

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
Endo Pharms Inc AVEED testosterone undecanoate INJECTABLE;INTRAMUSCULAR 022219-001 Mar 5, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). ➤ 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 8,338,395

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
7,718,640 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,338,395

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
South Korea 20080096717 ➤ Subscribe
Montenegro P14508 ➤ Subscribe
Norway 20054711 ➤ Subscribe
Mexico PA04002395 ➤ Subscribe
South Korea 100882378 ➤ Subscribe
South Korea 20050109561 ➤ Subscribe
Japan 4680891 ➤ Subscribe
Japan 2006520377 ➤ Subscribe
Jordan 2505 ➤ Subscribe
Iceland 2565 ➤ Subscribe
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving leading biopharmaceutical companies globally:

UBS
Teva
Deloitte
Julphar
Harvard Business School
McKinsey
Healthtrust
Farmers Insurance
Baxter

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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