DURVALUMAB | B761069 | ASTRAZENECA UK LTD
Earliest legal licensure (12-year BPCIA floor)
The 12-year reference-product exclusivity is the non-carveable floor — the earliest FDA could license a biosimilar for any indication. Unverified estimate — derived from the earliest available approval record (May. 1, 2017), not an FDA-stated exclusivity date. Shown with lower confidence than a Purple Book value.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | May. 1, 2029 | 2y 9mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Dec. 4, 2031 | 5y 4mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT)", protected through 2031-12-04) advances biosimilar entry from the full-label date to the estimated 12-year floor.
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT)(label indication #4) | Dec. 4, 2031 | Oct. 21, 2029(next orphan wall) |
| treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)(label indication #7) | Oct. 21, 2029 | Sep. 2, 2029(next orphan wall) |
| treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC)(label indication #6) | Sep. 2, 2029 | May. 1, 2029(12-yr RPE floor) |
Each rung drops one orphan-designated indication (sourced from the FDA Orphan Drug Product designation database and matched to the reference label); dropping the latest-walled indication advances biosimilar entry to the next constraint, until every orphan wall is carved and entry reaches the RPE floor.
Carveable orphan wall · Dec. 4, 2031
Orphan-drug exclusivity runs past the licensure floor above, but it walls only its specific orphan-designated indication(s). A biosimilar can omit those indications (a “fewer-than-all-conditions” carve-out) and be licensed for the rest at the floor date, then add the protected indication back by supplement once the orphan period expires. It is not a licensure gate for the other indications.
Marketing-entry ceiling (litigation risk)
Patents do not gate FDA licensure of a biosimilar — FDA licenses biosimilars (full or carved label) without adjudicating any patent. These are a practical marketing-entry ceiling resolved in the § 262(l) patent dance and ordinary litigation. A formulation/compound patent caps practical skinny entry via litigation (Regeneron v. Mylan); a method-of-use patent is carveable and gates nothing.
Latest formulation/compound patent 12435133(composition)· AI-discovered, not Purple-Book-listed · relevance 82/100. This caps practical skinny-label entry; it does not move the licensure floor above.
20 formulation/compound (cap skinny entry) · 23 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12435133 | Formulation/compound | Oct. 2, 2045Active | Discovered |
| 12429485 | Other | Sep. 25, 2045Active | Discovered |
| 12403142 | Method-of-use (carveable) | Aug. 28, 2045Active | Discovered |
| 12377164 | Formulation/compound | Jul. 31, 2045Active | Discovered |
| 12337038 | Formulation/compound | Jun. 19, 2045Active | Discovered |
| 12338283 | Method-of-use (carveable) | Jun. 19, 2045Active | Discovered |
| 12281339 | Method-of-use (carveable) | Apr. 17, 2045Active | Discovered |
| 12209126 | Method-of-use (carveable) | Jan. 23, 2045Active | Discovered |
| 12186278 | Formulation/compound | Jan. 2, 2045Active | Discovered |
| 12178876 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 12144839 | Method-of-use (carveable) | Nov. 14, 2044Active | Discovered |
| 12016900 | Method-of-use (carveable) | Jun. 20, 2044Active | Discovered |
| 12012453 | Method-of-use (carveable) | Jun. 13, 2044Active | Discovered |
| 11977075 | Other | May. 2, 2044Active | Discovered |
| 11951166 | Method-of-use (carveable) | Apr. 4, 2044Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.
Top 50 of 51 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Bristol-Myers Squibb Co. et al v. AstraZeneca Pharmaceuticals LP et al 1 patentdurvalumab (IMFINZI); nivolumab (OPDIVO) | D. Del. | 2023-04-25 | Terminated 2023-07-31 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.