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List Of Orphan Drugs Going Generic In 2013

January 29, 2013

Express Scripts/Medco, which manages pharmacy benefits for employer health plans, produces an 11-page list in June 2012 (“Estimated Dates of Possible First-Time Generics/Rx-to-OTC Entry”), which identifies prescription drugs that have been or are expected to be released as generics in the future. The following is a subset of that list for Orphan Drugs that have been or are expected to be released as generics in 2013 per the Express Scripts/Medco document. Please keep in mind as noted in the list, that “information is current as of June 2012 and estimated dates are subject to change due to patent litigation, additional patents, exclusivities”. (Please note Mr. Ronald Rader’s comments below).

Brand    Name Generic    Name 2013    Month Indication
Zometa Zoledronic Acid Injection March Hypercalcemia of   Malignancy
Rilutek Riluzole June Amyotrophic Lateral Sclerosis (ALS)
Temodar Temozolomide  August Glioblastoma
Cerezyme Imiglucerase Injection August Gaucher Disease

Please notify at if any updates are available.

Please note that the link for the “Indication” Column is the FDA Orphan Drug Product Designation Database Link

Michael Glessner, from Thomson Reuters, writes a fascinating article for CHEManager on the expiration of Orphan Drug Exclusivity (ODE) in the United States, and what opportunities this presents to generic and Active Pharmaceutical Ingredient (API) manufacturers. 70 US orphan drugs will lose their ODE over the next 6 years. This provides an opportunity for manufacturers of generics and APIs contained in generic products :

“ … Because ODEs are not tied to patents, generics manufacturers can develop and often launch a drug protected by an ODE so long as the drug is approved for a different, non-infringing application ….. According to research compiled by Thomson Reuters, manufacturers are already producing or capable of producing commercial quantities of many of the APIs associated with drugs currently protected by ODEs …”.

Key to this article is Table 1 (available online), titled “API Development of Orphan Drugs”, which lists a small sample of the ODEs that expire 2013 – 2016, and the number of API manufacturers “who currently have these drugs under development or commercially available according to information in Thomson Reuters Newport Premium”.

References article titled, “A New Generic Wave Update, Courtesy of Express Scripts”

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

  1. Regarding Cerezyme “going generic” (a poor choice of terms, with this a biologic, not subject to generic approvals, but surely a target for biosimilars and biobetters), Genzyme has claimed U.S. patent protection by U.S. 6,451,600 with a calculated (not confirmed by examination of patent office files) expiration date in Sept. 2019. If 2013 were the actual patent expiration date, there presumably would already be ongoing clinical trials with biosimilars/biobetters, and much hype and also user community anticipation about impending filings, but I am not aware of any new imiglucerase products in U.S. trials, much less any companies hyping their preparing for filing.

    So, 2013 for Cerezyme may not be realistic.

    Ronald A. Rader
    President / Author & Publisher of BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets
    Biotechnology Information Institute

    • Thanks for your comments. We were hoping that you would respond to this Blog Post, as we could not find any other information for Cerezyme. As you pointed out, there would have been alot of hypte if this was the case. Please keep in mind that this was taken from the list provided by Medco/Express Scripts. We debated about this Blog Post, but went ahead with it.

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