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Last Updated: January 26, 2020

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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 fifty-one 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 Submissiondate
Endo Pharms Inc AVEED testosterone undecanoate INJECTABLE;INTRAMUSCULAR 022219-001 Mar 5, 2014 RX Yes Yes   Start Trial   Start Trial 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).   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,338,395

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 043603   Start Trial
Austria 336251   Start Trial
Australia 2004218893   Start Trial
Brazil PI0400214   Start Trial
Canada 2518910   Start Trial
Chile 2004000527   Start Trial
China 101884639   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Dow
Medtronic
Moodys
Boehringer Ingelheim

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