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Skinny Label (Section viii Carve-Out)

A generic drug approval strategy under 21 U.S.C. 355(j)(2)(A)(viii) that omits (carves out) patent-protected indications from the generic label, allowing launch before all brand patents expire.

How It Works

Skinny labeling allows a generic to enter the market for uses whose patents have expired, carving out indications whose method-of-use patents remain. A generic manufacturer submits an ANDA with a Section viii statement certifying that it is not seeking approval for the patented use. The Orange Book codes these as "use codes" (e.g., U-1, U-2) specifying the scope of each listed method patent. Skinny labels are a critical tool for generic entry on drugs with unexpired method-of-use patents on secondary indications. The GlaxoSmithKline v. Teva litigation over carvedilol (generic Coreg) nearly destroyed the skinny label pathway: the Federal Circuit held in 2021 that Teva's skinny label for hypertension (with the CHF indication carved out) could still infringe via induced infringement despite the carve-out. Teva petitioned for en banc review and Supreme Court certiorari, both denied. The Federal Circuit narrowed its decision on rehearing but the precedent chilled skinny-label generic launches for several years. FDA issued guidance in 2022 clarifying that accurate skinny labels should not support induced infringement liability, and subsequent decisions (including Amarin v. Hikma on icosapent ethyl in 2024) have generally returned to the pre-GSK interpretation. Skinny-label strategy is critical for drugs like Restasis, Suboxone, and numerous cardiovascular drugs where innovators have layered method-of-use patents over the original composition patent. Ongoing congressional debate would further protect skinny-label generic launches through statutory clarification.

Related Terms

  • Abbreviated New Drug Application (ANDA), The FDA application pathway for generic drugs, which requires proving bioequivalence to the brand-name drug rather than repeating full clinical trials.
  • Pay-for-Delay Settlement, A patent-litigation settlement in which a brand-name drug manufacturer pays a generic challenger to delay launching its generic version, preserving brand monopoly profits.
  • Patent Expiration, The date when a drug's patent protection ends, allowing generic or biosimilar manufacturers to produce competing versions.
  • Orange Book Listing, The FDA's publication of approved drug products with therapeutic equivalence ratings and associated patent and exclusivity information, used to determine generic substitution.

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About This Definition

This definition is part of the DrugPrice Drug Pricing Glossary, 49 terms explaining how prescription drug pricing works in the United States. All definitions are written in plain language for patients, caregivers, journalists, and healthcare professionals.

this entity is one of the U.S. Medicare prescription-drug pricing concepts that recurs across this site. The definition above is the technical answer; the paragraphs below add the practical context for how the concept connects to the CMS Medicare Part D Drug Spending data data behind every per-entity page on the site.

In the CMS Medicare Part D Drug Spending data data, this concept shapes one or more of the fields that drive the per-entity grades and rankings on this site. The methodology page describes which fields feed into which output; this glossary entry documents the underlying term.

Source: CMS Medicare Part D Spending, 2026.