BRENTUXIMAB VEDOTIN | B125388 | SEATTLE GENETICS
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 (Aug. 19, 2011), 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) | Aug. 19, 2023 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | Nov. 10, 2029 | 3y 3mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL)", protected through 2029-11-10) 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 pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL)(label indication #3) | Nov. 10, 2029 | Aug. 19, 2023(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 · Nov. 10, 2029
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 12364767(composition)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
34 formulation/compound (cap skinny entry) · 16 method-of-use (carveable — gate nothing) · 0 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12364767 | Formulation/compound | Jul. 17, 2045Active | Discovered |
| 12303724 | Method-of-use (carveable) | May. 15, 2045Active | Discovered |
| 12257340 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 12246196 | Formulation/compound | Mar. 6, 2045Active | Discovered |
| 12233155 | Formulation/compound | Feb. 20, 2045Active | Discovered |
| 12036286 | Formulation/compound | Jul. 11, 2044Active | Discovered |
| 11951173 | Formulation/compound | Apr. 4, 2044Active | Discovered |
| 11944689 | Formulation/compound | Mar. 28, 2044Active | Discovered |
| 11903948 | Formulation/compound | Feb. 15, 2044Active | Discovered |
| 11857565 | Formulation/compound | Dec. 28, 2043Active | Discovered |
| 11795229 | Method-of-use (carveable) | Oct. 19, 2043Active | Discovered |
| 11666657 | Formulation/compound | Jun. 1, 2043Active | Discovered |
| 11633494 | Formulation/compound | Apr. 20, 2043Active | Discovered |
| 11602525 | Formulation/compound | Mar. 9, 2043Active | Discovered |
| 11583590 | Formulation/compound | Feb. 16, 2043Active | 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 176 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Seagen Inc. v. Daiichi Sankyo Co., Ltd. 1 patentAntibody-drug conjugate (ADC) - DS-8201 with trastuzumab antibody and camptothecin derivative DXd | E.D. Tex. | 2020-10-19 | Terminated 2022-07-19 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.