AFLIBERCEPT | B125387 | REGENERON PHARMACEUTICALS
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Nov. 18, 2011 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | Feb. 8, 2030 | 3y 3mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication(s) (protected through 2030-02-08) advances biosimilar entry from the full-label date to now (no remaining licensure floor).
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| treatment of retinopathy of prematurity (ROP) | Feb. 8, 2030 | Open now(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 · Feb. 8, 2030
Orphan-drug exclusivity runs past the licensure floor, 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 now, 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 12331099(formulation)· AI-discovered, not Purple-Book-listed · relevance 98/100. This caps practical skinny-label entry; it does not move the licensure floor above.
116 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 2 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12331099 | Formulation/compound | Jun. 12, 2045Active | Discovered |
| 12178874 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 12049489 | Other | Jul. 25, 2044Active | Discovered |
| 12012444 | Other | Jun. 13, 2044Active | Discovered |
| 12005097 | Formulation/compound | Jun. 6, 2044Active | Discovered |
| 11944663 | Method-of-use (carveable) | Mar. 28, 2044Active | Discovered |
| 11730794 | Method-of-use (carveable) | Aug. 17, 2043Active | Discovered |
| 11667702 | Formulation/compound | Jun. 1, 2043Active | Discovered |
| 11596667 | Method-of-use (carveable) | Mar. 2, 2043Active | Discovered |
| 11576948 | Formulation/compound | Feb. 9, 2043Active | Discovered |
| 11524053 | Formulation/compound | Dec. 8, 2042Active | Discovered |
| 11433118 | Formulation/compound | Sep. 1, 2042Active | Discovered |
| 11426446 | Formulation/compound | Aug. 25, 2042Active | Discovered |
| 12163122 | Formulation/compound | May. 10, 2042Active | Purple Book |
| 12282004 | Formulation/compound | Dec. 9, 2041Active | Purple Book |
Showing 15 of 123 patents (latest expirations).
Approved Biosimilars
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 251 AI-discovered patents by relevance.
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2023-00532 | 10130681 | IPR | Celltrion, Inc. et al. | Final Written Decision | 2023-02-10 | 2024-08-23 |
| IPR2023-00442 | 10130681 | IPR | Samsung Bioepis Co., Ltd. | Final Written Decision | 2023-01-06 | 2024-06-14 |
| IPR2022-01225 | 10130681 | IPR | Mylan Pharmaceuticals Inc. et al. | Final Written Decision | 2022-07-01 | 2024-08-23 |
| IPR2023-00620 | 10406226 | IPR | Celltrion, Inc. | Institution Denied | 2023-02-28 | 2023-09-01 |
| IPR2023-01312 | 10464992 | IPR | Samsung Bioepis Co., Ltd. | Terminated-Adverse Judgment | 2023-08-18 | 2024-02-21 |
| IPR2023-00462 | 10464992 | IPR | Celltrion, Inc. et al. | Terminated-Adverse Judgment | 2023-01-17 | 2024-02-21 |
| IPR2021-00402 | 10464992 | IPR | Chengdu Kanghong Biotechnology Co., Ltd. et al. | Terminated | 2021-01-07 | — |
| IPR2025-01269 | 10828345 | IPR | Fresenius Kabi SwissBiosim, GmbH et al. | Institution Denied | 2025-07-14 | 2026-01-09 |
| PGR2021-00035 | 10828345 | PGR | Chengdu Kanghong Biotechnology Co., Ltd. et al. | Terminated | 2021-01-07 | — |
| IPR2023-00099 | 10857205 | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2022-10-28 | 2023-03-01 |
| PGR2021-00117 | 10857231 | PGR | Celltrion, Inc. et al. | Institution Denied | 2021-09-07 | 2022-03-15 |
| IPR2024-00201 | 10888601 | IPR | Biocon Biologics Inc. et al. | Terminated-Adverse Judgment | 2023-11-20 | 2024-07-30 |
| IPR2023-00739 | 10888601 | IPR | Samsung Bioepis Co., Ltd. | Terminated-Adverse Judgment | 2023-03-26 | 2024-07-30 |
| IPR2023-00533 | 10888601 | IPR | Celltrion, Inc. et al. | Final Written Decision | 2023-02-10 | 2024-08-23 |
| IPR2023-00566 | 10888601 | IPR | Samsung Bioepis Co., Ltd. | Final Written Decision | 2023-02-10 | 2024-08-23 |
| IPR2022-01226 | 10888601 | IPR | Mylan Pharmaceuticals Inc. et al. | Final Written Decision | 2022-07-01 | 2024-08-23 |
| IPR2025-01268 | 11084865 | IPR | Fresenius Kabi SwissBioSim GmbH et al. | Discretionary Denial | 2025-07-14 | 2025-11-20 |
| IPR2025-00456 | 11084865 | IPR | Celltrion, Inc. | Discretionary Denial | 2025-01-15 | 2025-06-25 |
| IPR2025-00233 | 11084865 | IPR | Formycon AG | Institution Denied | 2024-12-02 | 2025-06-02 |
| IPR2025-00176 | 11084865 | IPR | Samsung Bioepis Co., Ltd. | Institution Denied | 2024-11-20 | 2025-06-02 |
| IPR2024-00298 | 11253572 | IPR | Biocon Biologics Inc. et al. | Terminated-Adverse Judgment | 2023-12-18 | 2024-07-23 |
| IPR2024-00260 | 11253572 | IPR | Celltrion, Inc. et al. | Terminated-Adverse Judgment | 2023-12-14 | 2024-07-23 |
| IPR2023-00884 | 11253572 | IPR | Samsung Bioepis Co., Ltd. | Terminated-Adverse Judgment | 2023-04-27 | 2024-07-23 |
| IPR2022-01524 | 11253572 | IPR | Apotex Inc. et al. | Institution Denied | 2022-09-09 | 2023-03-10 |
| PGR2026-00039 | 12168036 | PGR | Biocon Biologics Limited et al. | Discretionary Denial | 2026-04-02 | 2026-09-24 |
| PGR2025-00085 | 12168036 | PGR | Alvotech USA Inc. et al. | Trial Instituted | 2025-09-17 | 2026-03-03 |
| IPR2022-00258 | 9254338 | IPR | Celltrion, Inc. et al. | Final Written Decision | 2021-12-09 | 2024-07-19 |
| IPR2022-00298 | 9254338 | IPR | Apotex Inc. et al. | Final Written Decision | 2021-12-09 | 2024-07-19 |
| IPR2021-00881 | 9254338 | IPR | Mylan Pharmaceuticals Inc. et al. | Final Written Decision | 2021-05-05 | 2024-07-19 |
| IPR2022-00301 | 9669069 | IPR | APOTEX INC. et al. | Final Written Decision | 2021-12-09 | 2024-07-19 |
| IPR2022-00257 | 9669069 | IPR | Celltrion, Inc. et al. | Final Written Decision | 2021-12-09 | 2024-07-19 |
| IPR2021-00880 | 9669069 | IPR | Mylan Pharmaceuticals Inc. et al. | Final Written Decision | 2021-05-05 | 2024-07-19 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| C.D. Cal. | 2025-06-17 | Terminated 2025-07-29 | — | |
| C.D. Cal. | 2024-01-10 | Terminated 2024-04-15 | — | |
| N.D.N.Y. | 2020-06-19 | Terminated 2024-11-13 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Buchanan Ingersoll & Rooney PC FDA-2026-P-2257 · 3 docket documents Buchanan Ingersoll & Rooney PC filed this citizen petition on behalf of an unnamed interested client under Federal Food, Drug, and Cosmetic Act sections 501(a)(2)(A), 502(a), 502(f), 503B, and 704, requesting that the FDA issue guidance clarifying that compounded ophthalmic bevacizumab products do n | Other | 2026-03-04 | Withdrawn | Buchanan Ingersoll & Rooney PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.