Insulin glargine (LANTUS) – USA

Insulin glargine (LANTUS) – USA

IPR decision (Dec .12, 2018):

AIA Review

Filing Date
Institution Date
Petitioner
Patent No.
Final Written Decision
IPR2017-01526
06/05/2017
12/13/2017
Mylan Pharmaceuticals Inc.,
7,476,652
Claims 1–25 are unpatentable
IPR2017-01528
06/05/2017
12/13/2017
Mylan Pharmaceuticals Inc.,
7,713,930
Claims 1–20 are unpatentable
US 7,476,652 (Sanofi-Aventis Deutschland GmbH; Exp: 01/23/2024 with PED) – OB listed

1. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin; at least one chemical entity chosen from polysorbate 20 and polysorbate 80; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.
7. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin, at least one chemical entity chosen from polysorbate and poloxamers; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.
24. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin: at least one chemical entity chosen from polysorbate and poloxamers; at least one preservative chosen from cresol; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 3.5 to 4.5.
US 7,713,930 (Sanofi-Aventis Deutschland GmbH; Exp: 12/13/2023 with PED) – OB listed

1. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin; at least one chemical entity chosen from esters and ethers of polyhydric alcohols; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

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