	US 11,865,089 B2
	Infusion dosage form of norepinephrine
Samarth Kumar, Gujarat (IN); Maheshkumar Parasmal Soni, Gujarat (IN); Praveen Kumar Srivastava, Gujarat (IN); Prashant Kane, Gujarat (IN); and Subhas Balaram Bhowmick, Baroda (IN)
Assigned to SUN PHARMACEUTICAL INDUSTRIES LIMITED, Maharashtra (IN)
Filed by Sun Pharmaceutical Industries Limited, Mumbai (IN)
Filed on Oct. 18, 2021, as Appl. No. 17/451,292.
Application 17/451,292 is a continuation of application No. 16/989,027, filed on Aug. 10, 2020, granted, now 11,197,838.
Claims priority of application No. 201921032096 (IN), filed on Aug. 8, 2019.
Prior Publication US 2022/0054434 A1, Feb. 24, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/137 (2006.01); A61K 9/08 (2006.01); A61K 47/02 (2006.01); A61K 47/18 (2017.01); A61K 9/00 (2006.01)

CPC A61K 31/137 (2013.01) [A61K 9/08 (2013.01); A61K 47/02 (2013.01); A61K 47/183 (2013.01); A61K 9/0019 (2013.01)]

34 Claims

1. An aqueous ready to infuse stable parenteral dosage form consisting essentially of:

a. norepinephrine or its pharmaceutically acceptable salt at a concentration ranging from to 75 micrograms/ml of norepinephrine base;

b. at least one sulfite antioxidant; and

c. at least one ion chelator,

wherein, after subjected to terminal sterilization by autoclaving and stored at 40° C. and 25% relative humidity for 6 months, the dosage form contains no more than 0.2% by weight of each of 1,2,3,4-tetrahydroisoquinoline-4,6,7-triol, 1,2,3,4-tetrahydroisoquinoline-4,7,8-triol, and 3,4-dihydroxybenzaldehyde.