getOrangeBookPatents

Free

Get the Orange Book patents and regulatory exclusivities listed for one NDA (expiry dates, substance/product/method-of-use flags, use codes, pediatric extensions marked *PED), its products with therapeutic equivalence codes, and the approved ANDA generics of the same ingredient, dosage form and route (count, first generic approval, applicants). Answers loss-of-exclusivity and generic-entry questions. Get the applicationNumber from searchOrangeBook or openfda-mcp searchDrugApprovals.

Try it

Open in playground

kirha tools run openfda_getOrangeBookPatents \
  --input '{
    "applicationNumber": "NDA209637 or 209637"
  }'

Uses the key saved by kirha auth login.

applicationNumberstring, required, Matches ^\s*(NDA|ANDA|N|A)?\s*\d{6}\s*$
e.g. NDA209637 or 209637 (NDA assumed when no prefix)