Summary
(1) As stated in the 02 Apr 2009 Press Release, Teva Pharmaceutical Industries Ltd. (NasdaqGS:TEVA) has launched its generic versions corresponding to the FDA-approved Orange Book Reference Listed Drug (RLD) medical products of ADDERALL XR Capsules (mixed salts of a single-entity amphetamine product; strengths/mg: 5 10 15 20 25 30) of Shire PLC (NasdaqGS:SHPGY). This event, although unfavorable to Shire, was clearly a known possibility. Its anticipated impact will likely be a decrease in Shire's American sales of ADDERALL XR Capsules. (2) Spillover damage for American sales of VYVANSE Capsules (lisdexamfetamine dimesylate; strengths/mg: 20 30 40 50 60 70) might be possible. The nexus between ADDERALL and VYVANASE follows. VYVANASE's Active Product Ingredient (API) is lisdexamfetamine dimesylate; a prodrug of dextroamphetamine. ADDERALL's APIs are a mixture of 4 related amphetamines. Thus, ADDERAL and VYVANASE are related medical products.
Analysis
* As background information, common features of VYVANASE and ADDERALL include treatment of Attention Deficit Hyperactivity Disorder (ADHD); once-a-day oral administration; and Schedule II classification.
* Actavis in a February 2009 Press Release (link to pr available at:
http://www.actavis.us/en/media+center/newsroom/default.htm) states that it has sued the FDA over the FDA's determination that VYVANASE properly qualifies to have the 5-year exclusivity associated with New Chemical Entity (NCE) status. If Actavis ultimately prevails in its fight with the FDA, then VYVANASE itself might have FDA-approved generic equivalents sooner than expected.
* Conclusion: In light of both the related APIs of VYVANASE and ADDERALL and potential real-world uses of generic ADDERALL in lieu of VYVANASE, irrespective of official FDA regulatory status differences of VYVANASE and ADDERALL, - American sales of VYVANASE might decrease. The Actavis attack represents another potential problem relating to VYVANASE.
