IPR decision: Aug 02, 2019
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AIA Review
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Filing Date
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Institution Date
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Petitioner
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US Patent
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Respondent
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Decision
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IPR2019-01021
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04/26/2019
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—
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Adamis Pharma
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9,283,197
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Belcher Pharma
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Terminated-Settled
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US 9,283,197 (Taneja; Jugal K.; Exp: 08/15/2034) – OB listed
1. A liquid pharmaceutical formulation of preservative-free and sulfite-free, 1 mg per mL l-epinephrine sterile solution for uses including injection; said liquid pharmaceutical formulation having a pH between 2.8 and 3.3; said liquid pharmaceutical formulation compounded in an aqueous solution as 1.0 to 1.06 mg/mL l-epinephrine, and further including a tonicity agent; said liquid pharmaceutical formulation having no more than 6.5% total impurities at release, including no more than 6% d-epinephrine and no more than 0.5% adrenalone, and no more than 12.5% total impurities over a shelf-life of at least 12 months, including no more than 12% d-epinephrine and no more than 0.5% adrenalone; said liquid pharmaceutical formulation stored in a container with an inert gas prior to use.
4. A liquid pharmaceutical formulation of preservative-free and sulfite-free, 1 mg per mL l-epinephrine sterile solution for uses including injection; said liquid pharmaceutical formulation having a pH between 2.8 and 3.3; said liquid pharmaceutical formulation compounded as 1.0 to 1.06 mg/mL l-epinephrine, along with 8.6 mg/mL sodium chloride as the tonicity agent, 7.26 mg/mL of 1 Normal hydrochloric acid as the dissolution agent, 987.11 mg/mL water for injection as a solvent, and with additional hydrochloric acid to adjust pH; said liquid pharmaceutical formulation having less than 6.5% total impurities at release, including less than 6% d-epinephrine and less than 0.5% adrenalone, and less than 12.5% total impurities over a shelf-life of at least 12 months, including less than 12% d-epinephrine and less than 0.5% adrenalone.
6. An injectable liquid pharmaceutical formulation of l-epinephrine sterile solution; said liquid pharmaceutical formulation having a pH between 2.8 and 3.3; said injectable liquid pharmaceutical formulation compounded in an aqueous solution as 1.0 to 1.06 mg/mL l-epinephrine, and further including a tonicity agent; said liquid pharmaceutical formulation including no more than about 6% d-epinephrine and no more than about 0.5% adrenalone at release, and no more than about 12% d-epinephrine and no more than about 0.5% adrenalone over a shelf-life of at least 12 months.
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