?TOISB/05 {07-07)
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`"I
`UTILITY
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`
`Affomey Docket No.
`
`First Inventor
`
`iitle
`
`·1
`
`l 077350 .0344
`i Chowdhury et al
`--··
`Dexmedetomidine Premix Formulation
`
`Express Mail Lebel No.
`
`~
`
`,
`
`\...
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`APPLICATION ELEMENTS
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`ADDRESS TO:
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`Petition for Inter Partes Review of US 8,242, 158
`Amneal Pharmaceuticals LLC - Exhibit 1008 - Page 1
`
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 2
`
`

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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 3
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 4
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 5
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 6
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 7
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 8
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 9
`
`

`
`077350.0344
`
`CH3
`
`CH3
`
`CH3
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`~
`
`Formula I
`
`N
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`< N
`\
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`H
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`(0024}
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`The terms "premix" or "premixture" as used herein refers to a pharmaceutical
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`formulation that does not require reconstitution or dilution prior to administration to a patient.
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`For example, in contrast to non-premixed formulations of dexmedetomidine, the premixed
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`compositions provided herein are suitable for administration to a patient without dilution by, for
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`example, a clinician, hospital personnel, caretaker, patient or any other individual.
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`[0025)
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`In certain embodiments, the compositions of the present invention can be
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`formulated as "ready to use" compositions which refer to premixed compositions that are
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`suitable for administration to a patient without dilution. For example, in certain embodiments,
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`the compositions of the present invention are "ready to use" upon removing the compositions
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`from a sealed container or vessel.
`[0026}
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`1n certain embodiments, the compositions of the present invention can be
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`formulated as a "single use dosage," which refers to a premixed composition that is disposed
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`within a sealed container or vessel as a one dose per container or vessel formulation.
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`[0027)
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`According to the invention, a "subject" or "patient" is a human, a non-human
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`mammal or a non-human animal. Although the animal subject is preferably a human, the
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`compounds and compositions of the invention have application in veterinary medicine as well,
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`e.g., for the treatment of domesticated species such as canine, feline, and various other pets; farm
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`animal species such as bovine, equine, ovine, caprine, porcine, etc.; wild animals, e.g., in the
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`wild or in a zoological garden; and avian species, such as chickens, turkeys, quail, songbirds, etc.
`
`[0028]
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`The term "purified" as used herein refers to material that has been isolated under
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`conditions that reduce or eliminate the presence of unrelated materials, i.e., contaminants,
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`including native materials from which the material is obtained. As used herein, the te1m
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`"substantially free" is used operationaUy, in the context of analytical testing of the material.
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`Preferably, purified material substantially free of contaminants is at least 95% pure; more
`
`NY02;7324l0. l
`
`- 5 -
`
`Petition for Inter Partes Review of US 8,242, 158
`Amneal Pharmaceuticals LLC - Exhibit 1008 - Page 1 O
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 11
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 12
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1008 – Page 13
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