FDA Approves Generic Release of Abilify
Posted on May 1, 2015 by Rita Wilson
The U.S. Food and Drug Administration (FDA) approved the first AB-rated generics to Bristol-Myers Squibb and Otsuka’s Abilify® (aripiprazole) tablets, an atypical antipsychotic drug commonly used for treating schizophrenia and bipolar disorder. The agency approved generics from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals. At least one manufacturer, Teva, announced the launch of its generic in the currently marketed strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg tablets.
Specifics of Release
- Brand Name: Abilify® (aripiprazole – Bristol-Myer’s Squibb/Otsuka)
- Indication: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, treatment of irritability associated with autistic disorder and treatment of Tourette’s disorder.
- Generic Manufacturer(s): Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals
- Launch Date: April 28, 2015
Potential Obstacles and Alternatives
- Teva’s launch is considered “at risk” due to ongoing litigation over three later listed patents in FDA’s Orange Book covering Abilify. The other manufacturers have not yet announced the launch of their generics.
- Other atypical antipsychotic medications include Clozaril® (clozapine – Novartis, generics), Fanapt™ (iloperidone – Vanda), Geodon® (ziprasidone – Pfizer, generics), Invega™ (paliperidone – Janssen), Latuda® (lurasidone– Sunovion), Risperdal® (risperidone – Janssen, generics), Saphris® (asenapine – Merck / Actavis), Seroquel® (quetiapine – AstraZeneca, generics) and Zyprexa® (olanzapine – Lilly, generics).
The Good, the Bad and the Ugly
- The good….As an expensive brand medication commonly prescribed in workers’ comp for off label use for depression and sleep related issues, the release of generic Abilify® (aripiprazole) tablets is certainly a welcomed event for our MSA submissions.
- The bad….We know from past history that price concessions during the initial generic release period are normally no more than 10-12% off the original brand AWP (average wholesale price).
- The ugly… We also know from past history that as one brand moves to generic, soon to follow are new and even more expensive alternatives. Two new atypical antipsychotic drugs are currently under FDA review. Actavis’ cariprazine could be approved during the second quarter of 2015. Brexpiprazole, Otsuka’s follow-on to Abilify, has an FDA action date of July 11, 2015.
Impact on CMS Review of WCMSAs:
Abilify is an expensive medication used off label by many physicians in workers’ comp. As such, it is consistently identified as a medication trigger in our pre-MSA review and triage process. When possible our team of physicians attempt collegial dialogue with the treating physician to discuss the nature of the injury and causal relationship with psych conditionals, and to specifically discuss the rationale behind off label use of Abilify.
According to ODG (Official Disabilities Guideline), Abilify is a ‘N’ drug (as are all atypical anti-psychotic medications), meaning it is not appropriate for first-line therapy. This is how Medicare views Abilify, and why it’s critical to address Abilify’s use before it shows up as treatment on an MSA. As an ‘N’ drug, Ability should go thru a pre-authorization process where the prescriber justifies its use before being dispensed through the PBM.
For questions about Abilify, its generic release, its use in WCMSAs, both FDA approved and off label uses, please contact us @ firstname.lastname@example.org or 888-331-4941.
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