FDA Orange Book Exclusivity Codes and Expiry Guide
Inspect US FDA Orange Book statutory exclusivity records and listed patents, starting from the pinned September 2026 incretin dataset. NDA209637 (Ozempic) carries a single new-indication exclusivity (I-961) in this capture; the tirzepatide NDAs carry the 5-year New Chemical Entity (NCE) code. Statutory exclusivities and listed USPTO patents arise from separate legal frameworks and are evaluated as distinct records.
Uses the shipped September 2026 FDA Orange Book capture (EOBZIP_2026_09.zip, retrieved 14 October 2026), opened on NDA209637. In this capture NDA209637 lists exclusivity I-961 (to 28 January 2028) and no NCE, ODE or PED; the NCE code appears on the tirzepatide applications NDA215866 and NDA217806. Exclusivity codes and expiry dates are read per application and product number.
Distinguish NCE, ODE, 3-year clinical, and pediatric exclusivity codes
The FDA Orange Book contains two separate protection tables linked by application number (NDA) and product number: `Patent.txt` and `Exclusivity.txt`. While patent listings reflect patent numbers and expiration dates submitted by the NDA holder on Form FDA 3542, exclusivity records reflect statutory protections administered by the FDA under the Hatch-Waxman Amendments, the Orphan Drug Act, and the Best Pharmaceuticals for Children Act.
Four principal exclusivity categories appear across small-molecule NDAs: (1) five-year New Chemical Entity (NCE) exclusivity granted when no active moiety of the drug has been previously approved by the FDA, generally barring submission of an ANDA or 505(b)(2) application for five years (or four years if accompanied by a Paragraph IV certification against a listed patent); (2) seven-year Orphan Drug Exclusivity (ODE) blocking approval for the same drug and designated rare-disease indication; (3) three-year new clinical investigation exclusivity (such as NPP for a new patient population or new dosage form) requiring essential new clinical studies other than bioavailability trials; and (4) six-month Pediatric Exclusivity (PED) attaching to existing patents and exclusivities.
Inspect product-level granularity and snapshot dates before reading a timeline
Within a single NDA (such as NDA209637 in the pre-loaded September 2026 incretin capture, which has seven product numbers), multiple product numbers correspond to distinct strengths or presentations. An exclusivity code or patent use code may apply only to specific product numbers or approved labeling indications rather than the entire active ingredient across all strengths.
Always verify both the capture timestamp of the Orange Book data file (`EOBZIP_2026_09.zip`) and the record type before comparing dates. Do not collapse statutory exclusivity expiration dates and patent expiration dates into a single unlabeled "loss of exclusivity" number, as each mechanism carries distinct legal rules and exceptions.
Equations and variables
Calendar distance from comparison date to a listed exclusivity or patent date
Δt = tlisted − tcomparison
- Δt
- Calendar interval between the explicit comparison reference date and the source date (days or years)
- tlisted
- Expiration date recorded in the FDA Orange Book exclusivity or patent table
- tcomparison
- Explicit reference date selected for timeline comparison
Pediatric exclusivity 6-month statutory attachment relationship
tPED-linked = tbase-patent-or-exclusivity + 6 calendar months (where listed by FDA)
- tPED-linked
- Extended regulatory bar date reflected in an accompanying *PED Orange Book row
- tbase-patent-or-exclusivity
- Underlying listed patent expiration or statutory exclusivity expiration date
Scope and limitations
- US FDA Orange Book scope only: statutory exclusivities (NCE, ODE, NPP, PED) govern FDA submission or approval timing of 505(b)(2) and 505(j) applications and do not apply outside the United States.
- Once an exclusivity period has expired and been removed from the current cumulative Orange Book file, its absence from a current snapshot does not mean the application never held NCE or pediatric exclusivity at launch.
- Not legal, regulatory, medical, or investment advice; listed dates describe FDA source files as they stand and do not forecast generic launch dates or freedom to operate.
Sources and provenance
- FDA Orange Book data filesFDA source terms; no new licence classification
Listed protection is not a claim construction or freedom-to-operate opinion.
- FDA Orange Book preface: statutory exclusivity definitions and codesFDA source terms; methodology and code reference
- 21 CFR 314.108 new drug product exclusivity regulationsUS government public domain; statutory exclusivity framework
Technical questions
How does FDA statutory exclusivity differ from a listed Orange Book patent?
Patents are property rights granted by the US Patent and Trademark Office (USPTO) for a 20-year term from filing and can be challenged for invalidity or non-infringement in court. Statutory exclusivities (such as 5-year NCE, 7-year Orphan Drug, or 3-year clinical investigation exclusivity) are regulatory protections granted by the FDA upon drug approval under the FD&C Act that restrict when the FDA may accept or approve certain abbreviated applications, regardless of whether any patent exists.
How is 6-month pediatric exclusivity (PED) represented in the Orange Book tables?
Under Section 505A of the FD&C Act, qualifying pediatric studies attach an additional 6-month period of marketing protection to existing listed patents and exclusivities for the moiety. In the Orange Book patent table, the FDA commonly lists the original patent row alongside a second linked row carrying the patent number suffixed with "*PED" and an expiration date shifted forward by six months.
Why does NDA209637 show only one exclusivity row in this capture?
The monthly FDA Orange Book distribution lists only unexpired exclusivities. Semaglutide was approved in 2017, so its original 5-year NCE exclusivity has long expired and been dropped from Exclusivity.txt; the row that remains, I-961, is a newer new-indication exclusivity. Longer-lived patents stay in Patent.txt.
Connected workflows
- US incretin listed-patent inspection
Inspect the full US incretin listed-patent and exclusivity workspace.
- KRAS G12D trial-record exploration
Contrast post-approval exclusivity records with early clinical trial landscapes.
- Lipinski rule-of-five property inspection
Compare small-molecule structural properties in the molecule workbench.