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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Colorcon
Merck
Deloitte
Covington
Accenture
UBS
Medtronic
Chubb

Generated: May 22, 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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,338,395
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 ➤ Sign Up ➤ Sign Up 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). ➤ Sign Up
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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
AstraZeneca
Citi
Healthtrust
Boehringer Ingelheim
Chubb
McKinsey
Cantor Fitzgerald
Queensland Health

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