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K-V Pharmaceutical And Orphan Drug Makena: Legal Update (December 21, 2012)

December 22, 2012

       K-V Pharmaceutical loses its trade complaint that it files in October 2012 with the US International Trade Commission (ITC). The complaint is an attempt to stop compounding pharmacies from importing 17a hydroxyprogesterone caproate (“HPC”) to unlawfully manufacture copies of orphan drug Makena.  The US ITC says it will not investigate the complaint.

       A historical timeline of the K-V Pharmaceutical trade complaint with the US ITC :       

  1. On October 23, 2012, K-V Pharmaceutical files a trade complaint with the US 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
  2. 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
  3. The complaint alleges that 46 entities unlawfully imports into the US, sells for importation, and/or use imports “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”.

       The Texas Tribune, in a December 18, 2012 article,  states that Texas may be the next state that K-V Pharmaceutical sues over orphan drug Makena. The company has sued Medicaid officials in Illinois, Georgia, and South Carolina. No law suit has been filed in Texas yet. According to the article, K-V Pharmaceutical says that “Texas’ Medicaid policy is unacceptable as written …. it approves Makena … only if there is no compounding pharmacy within 50 miles of their doctor’s office, and none that will deliver “.

References December 21, 2012 article titled, “K-V Complaint Over Compound Medicine Rejected by U.S. ITC’’

The Texas Tribune December 18, 2012 article titled, “State, Drug Company at Odds Over Pre-Term Birth Therapy”

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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