grepcent public filings, reorganized for comparison

OTEZLA / OTEZLA XR — FDA application NDA210745

Application NDA210745 · type NDA · FDA status: approved · original approval 2025-08-29

Listed sponsor: AMGEN INC · AMGN company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001OTEZLA XRAPREMILASTTABLET, EXTENDED RELEASEORAL75MGPrescriptionnot listedYes
002OTEZLAAPREMILASTTABLETORAL10MGPrescriptionnot listednot listed
003OTEZLAAPREMILASTTABLETORAL20MGPrescriptionnot listednot listed
005OTEZLAAPREMILASTTABLETORAL30MGPrescriptionnot listednot listed

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 7427638001listed patent expiry date: 2028-02-16drug substance, drug product
Patent 10092541001listed patent expiry date: 2034-05-29U-2659
Patent 11752129001listed patent expiry date: 2042-05-27drug product, U-4264
Patent 11752129001listed patent expiry date: 2042-05-27drug product, U-4265
Patent 11752129001listed patent expiry date: 2042-05-27drug product, U-4266
Patent 11969409001listed patent expiry date: 2042-05-27drug product
Patent 12427136001listed patent expiry date: 2042-05-27U-1858
Patent 12427136001listed patent expiry date: 2042-05-27U-4290
Patent 12427136001listed patent expiry date: 2042-05-27U-4291
Exclusivity ODE*001listed exclusivity date: 2026-07-19FDA code as listed
Exclusivity M-299001listed exclusivity date: 2026-07-20FDA code as listed
Exclusivity PED001listed exclusivity date: 2027-01-19FDA code as listed
Exclusivity PED001listed exclusivity date: 2027-01-20FDA code as listed
NDA210745 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210745 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210745 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002025-08-291.002026-07-191.002026-07-201.002027-01-191.002027-01-201.002028-02-161.002034-05-291.002042-05-271.00

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

Compound cross-links

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Related pages

Sponsor company · FDA-approved application index

Peer clusters: Large-cap biopharma

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.