Details for Patent: 12,427,104

Which drugs does patent 12,427,104 protect, and when does it expire?

Patent 12,427,104 protects KYXATA and is included in one NDA.

Summary for Patent: 12,427,104

Title:	Injectable carboplatin formulations
Abstract:	Described herein are injectable carboplatin formulations, comprising: about 10 mg/mL of carboplatin; and a pharmaceutically acceptable vehicle; wherein the formulation has a pH of from about 5 to about 7; wherein the formulation has a dissolved oxygen level of not less than about 28 ppm; wherein the formulation is filled in a vial at a fill volume of from about 1 mL to about 70 mL in a vial having a capacity of from about 1 mL to about 100 mL; wherein the vial has head space ranging from about 20% to about 82%; and wherein the headspace comprises oxygen gas in an amount effective to maintain a 1,1-cyclobutanedicarboxylic acid level of not more than 1.0%, based on the weight of carboplatin, and a total degradation impurity level at not more than 2.5%, based on the weight of carboplatin, when stored at room temperature for 24 months.
Inventor(s):	Mukteeshwar Gande, Praveen Reddy Billa, Venkata S. Varanasi, Samir Chimanlal Mehta
Assignee:	Ingenus Pharmaceuticals LLC
Application Number:	US19/097,811
Patent Claim Types: see list of patent claims	Use; Formulation;

Drugs Protected by US Patent 12,427,104

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Avyxa Holdings	KYXATA	carboplatin	SOLUTION;INTRAVENOUS	219921-001	Aug 8, 2025		DISCN	Yes	No	12,427,104		Y
Avyxa Holdings	KYXATA	carboplatin	SOLUTION;INTRAVENOUS	219921-002	Aug 8, 2025		RX	Yes	Yes	12,427,104		Y
Avyxa Holdings	KYXATA	carboplatin	SOLUTION;INTRAVENOUS	219921-003	Aug 8, 2025		RX	Yes	Yes	12,427,104		Y