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Why Is K-V Pharmaceutical And Orphan Drug Makena In The News Again ?

October 28, 2012

       On October 23, 2012, K-V Pharmaceutical files a trade complaint with the US International Trade Commission (ITC), accusing 46 compounding pharmacies of infringing on its property rights. K-V Pharmaceutical asks the International Trade Commission (ITC) to start an investigation pursuant to Section 337. 

         The New England Compounding Pharmacy Inc., linked to the recent deadly meningitis outbreak in the US, is one of the compounding pharmacies identified in the complaint. 

       The complaint alleges that 46 entities unlawfully imports into the US, sells for importation, and/or use imports 17a hydroxyprogesterone caproate (“HPC”) to unlawfully manufacture copies of orphan drug Makena. The complaint goes on to say that the FDA designates Makena as an “orphan drug” and is the “only FDA-approved HPC drug that may be marketed in the US …. until February 2018.” K-V Pharmaceutical asks that the ITC “issue a general exclusion order and a cease and desist order barring imports of HPC”. 

References October 25, 2012 article titled,”K-V Pharmaceutical, Apple, Huawei: Intellectual Property” 

International Trade Commission (ITC) Docket # 2919 – Notice of Receipt of Complaint October 24, 2012 article titled,”KV Files New 337 Complaint Regarding Hydroxyprogesterone Caproate and Products Containing Same” October 24, 2012 article titled,”K-V Takes Fight Over Makena Knockoffs to ITC” (May need subscription for access) October 24, 2012 article titled,”KV files 337 complaint regarding hydroxyprogesterone caproate and products containing same”.          

Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

  1. Dingleberry permalink

    HPC is a legal drug monographed in the current USP. It is not covered by US or foreign patent. It can be legally imported into the USA for use in compounded prescriptions. KV has no legal rights regarding the active drug HPC.
    Regarding the exclusivity afforded by the Orphan Drug Act (in which Makena was approved), the exclusivity is based on the commitment from the FDA not to approve another similar product to Makena during the exclusivity period…. and that is just what FDA has done and will do for the remainder of the exclusivity period. Compounded prescriptions containing HPC are not addressed in the exclusivity provisions of the Orphan Drug Act.

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