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Last Updated: November 30, 2020

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Claims for Patent: 9,616,049

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Summary for Patent: 9,616,049
Title:Dexmedetomidine premix formulation
Abstract: The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.
Inventor(s): Roychowdhury; Priyanka (Foster City, CA), Cedergren; Robert A. (Libertyville, IL)
Assignee: HOSPIRA, INC. (Lake Forest, IL)
Application Number:15/058,602
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,616,049
Patent Claims: 1. A ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 .mu.g/mL disposed within a sealed glass container, wherein the liquid pharmaceutical composition has a pH of about 2 to about 10.

2. The ready to use liquid pharmaceutical composition of claim 1, wherein the liquid pharmaceutical composition has a pH of about 4 to about 8.

3. The ready to use liquid pharmaceutical composition of claim 1, wherein the liquid pharmaceutical composition has a pH of about 4.5 to about 8.

4. The ready to use liquid pharmaceutical composition of claim 1, wherein the liquid pharmaceutical composition has a pH of between about 4.5 and about 7.

5. The ready to use liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0.05 to about 15 .mu.g/mL.

6. The ready to use liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 0.5 to about 10 .mu.g/mL.

7. The ready to use liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 1 to about 7 .mu.g/mL.

8. The ready to use liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is at a concentration of about 4 .mu.g/mL.

9. The ready to use liquid pharmaceutical composition of claim 1, further comprising sodium chloride at a concentration of between about 0.01 and about 2.0 weight percent.

10. The ready to use liquid pharmaceutical composition of claim 9, wherein the sodium chloride is present at a concentration of about 0.9 weight percent.

11. The ready to use liquid pharmaceutical composition of claim 1, wherein the composition is formulated as a total volume selected from the group consisting of 20 mL, 50 mL and 100 mL.

12. The ready to use liquid pharmaceutical composition of claim 1, wherein the dexmedetomidine is formulated as a hydrochloride salt.

13. The ready to use liquid pharmaceutical composition of claim 1, wherein the liquid pharmaceutical composition is terminally sterilized.

14. The ready to use liquid pharmaceutical composition of claim 13, wherein the liquid pharmaceutical composition is terminally sterilized by autoclave.

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