Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N020622

Product 003
GLATIRAMER ACETATE (COPAXONE) INJECTABLE 40MG/ML

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 8232250 08/19/2030
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
02/26/2014
003 8399413 08/19/2030
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
02/26/2014
003 8969302 08/19/2030
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
03/03/2015
003 9155776 08/19/2030
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
10/13/2015
003 9402874 08/19/2030
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
08/02/2016

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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