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When will otezla go generic?

See the DrugPatentWatch profile for otezla

Short answer:
There isn’t a specific “generic‑release date” that has been set for Otezla (apremilast) yet. The drug is still protected by a cluster of patents that are set to expire between 2027 and 2032 in the United States. In practice, a generic version would only be approved after those patents (or the ones that the FDA deems most important) have expired or been invalidated, and then after the generic manufacturer completes its own FDA filing and review. That usually takes a few additional years.

Why it isn’t out yet

Patent Scope File date Expiry date Relevance to generics
US 7,748,464 – Method of treating psoriasis with apremilast Main therapeutic claim 2007‑02‑27 2027‑02‑27 The most critical patent for the psoriasis indication.
US 8,269,724 – Method of treating psoriatic arthritis with apremilast Arthritis indication 2012‑03‑08 2032‑03‑08 Covers the arthritis indication, but may be less critical for a psoriasis generic.
US 8,752,380 – Pharmaceutically acceptable salt of apremilast Drug product form 2015‑02‑05 2032‑02‑05 Protects the specific salt formulation sold as Otezla.
US 8,752,381 – Combination therapy Combination products 2015‑02‑05 2031‑02‑05 Covers certain combination therapies (e.g., with biologics).
US 8,752,384 – Combination therapy Combination therapies 2015‑02‑05 2032‑02‑05 Same as above.

Note: Patent term extensions (the Hatch‑Waxman “patent‑term‑extension” mechanism) can add up to 5 years to a drug’s exclusivity. Pfizer has requested extensions that push some of these expiry dates to the early‑2030s.

Because of this array of overlapping patents, a generic manufacturer would have to wait until all relevant patents are gone (or until the FDA determines that a particular patent is not enforceable) before a generic can be approved.

The generic approval path

  1. Patent expiration / invalidation – The first step is that the key patents are no longer enforceable.
  2. Generic filing (ANDA) – A generic manufacturer files an Abbreviated New Drug Application (ANDA) with the FDA.
  3. FDA review – The FDA reviews the ANDA, focusing on bioequivalence, labeling, and safety. This can take 12–24 months once the application is accepted.
  4. Approval & launch – After FDA approval, the generic can be marketed, but the manufacturer must still negotiate pricing, distribution, and marketing.

If all key patents expire in 2027, the earliest a generic could theoretically be approved would be late 2027 – 2028 (after a year or two of FDA review). If the last patent expires in 2032, then the earliest generic launch would likely be 2033 – 2034.

What’s happening now?



Other Questions About Otezla :

Otezla amgen? Otezla loss of exclusivity in europ e? Otezla clinical trials? Otezla loe date? Otezla net price evolution? Otezla precio? Otezla 30 mg cost?