Pomalidomide fda approval date exclusivity?

When did the FDA first approve pomalidomide?
The FDA approved pomalidomide (brand name Pomalyst) on April 23, 2013 for relapsed or refractory multiple myeloma. [1]

How long did the drug’s exclusivity last?
Pomalidomide received five years of data exclusivity, the standard period for a new chemical entity. The exclusivity began on the approval date and ended on April 23, 2018. [2]

What type of exclusivity applies to pomalidomide?
Because pomalidomide is a new small‑molecule drug and not an orphan product, it falls under the standard “new chemical entity” exclusivity rule. This grants a 5‑year period during which the FDA will not approve generic versions based on the sponsor’s data. [2]

Does the exclusivity cover all indications or just the first?
The 5‑year exclusivity applies to the approval for all indications that were approved at the time of the original filing. If the sponsor obtains additional indications later, each new indication can trigger its own separate exclusivity period. [3]

What happens after the exclusivity period ends?
Once the exclusivity expires, other manufacturers can submit generic applications. However, they must still demonstrate that their product is bioequivalent to the brand drug. The first generic approval will typically occur a few years after exclusivity ends, depending on regulatory review and market strategy. [3]

Can other companies make generic pomalidomide now?
The exclusivity expired in 2018. Since then, generic versions have entered the market, and multiple generic manufacturers currently offer pomalidomide. [3]

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Sources

1. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/pomalyst-approval
2. https://www.fda.gov/drugs/laws-regulations-and-policy/market-exclusivity-new-drugs-and-biosimilars
3. https://www.fda.gov/drugs/marketing-approval-drugs/generic-drug-approval-process