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Details for Patent: 8,338,395

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Patent 8,338,395 protects AVEED and is included in one NDA. There has been one Paragraph IV challenge on Aveed.

This patent has forty-four patent family members in thirty-six 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;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 17th percentile
Forward Citations: 2nd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Endo Pharms Inc
AVEED
testosterone undecanoate
INJECTABLE;INTRAMUSCULAR022219-001Mar 5, 2014RXYes8,338,395► 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).
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Non-Orange Book Patents 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
7,718,640Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels► 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: 8,338,395

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Norway335179► subscribe
CroatiaP20050781► subscribe
Israel170473► 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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