INSULIN GLARGINE | B210605 | MYLAN PHARMS INC
Deemed transition product — no fresh 12-year exclusivity
Approved as an NDA and deemed licensed under PHS Act § 351(a) on March 23, 2020 (BPCIA transition — insulins, human growth hormone, etc.). Under § 262(k)(7)(D) a deemed product receives no fresh 12-year reference-product exclusivity, so no BPCIA floor date is computed here. A biosimilar is not blocked by any 12-year exclusivity; any orphan or pediatric exclusivity is preserved and shown below.
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 12186374(formulation)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
22 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 24 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12318584 | Other | May. 29, 2045Active | Discovered |
| 12233247 | Other | Feb. 20, 2045Active | Discovered |
| 12186374 | Formulation/compound | Jan. 2, 2045Active | Discovered |
| 11957879 | Other | Apr. 11, 2044Active | Discovered |
| 11952602 | Other | Apr. 4, 2044Active | Discovered |
| 11518988 | Other | Dec. 1, 2042Active | Discovered |
| 11396534 | Formulation/compound | Jul. 21, 2042Active | Discovered |
| 11197959 | Other | Dec. 9, 2041Active | Discovered |
| 11191722 | Formulation/compound | Dec. 2, 2041Active | Discovered |
| 11060058 | Other | Jul. 8, 2041Active | Discovered |
| 11026999 | Formulation/compound | Jun. 3, 2041Active | Discovered |
| 10874799 | Other | Dec. 24, 2040Active | Discovered |
| 10610595 | Formulation/compound | Apr. 2, 2040Active | Discovered |
| 10532160 | Other | Jan. 9, 2040Active | Discovered |
| 10500346 | Other | Dec. 5, 2039Active | 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 181 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
SANOFI-AVENTIS U.S. LLC et al v. MYLAN N.V. et al 18 patentsinsulin glargine [rDNA origin] | D.N.J. | 2017-10-24 | Terminated 2020-11-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.