Details for Patent: 12,138,271

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Which drugs does patent 12,138,271 protect, and when does it expire?

Patent 12,138,271 protects AZMIRO and is included in one NDA.

Summary for Patent: 12,138,271

Title:	Pharmaceutical compositions of testosterone
Abstract:	Stable pharmaceutical compositions are provided, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions and methods of using such pharmaceutical compositions for hormone replacement therapy, e.g., in a male patient having a condition associated with symptoms of deficiency or absence of endogenous testosterone.
Inventor(s):	Umangi K. SONI, Prem Prakash SINGH, Hanimi Reddy BAPATU, Praveen Kumar Subbappa, Ajay Kumar Singh
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US18/299,493
Patent Claim Types: see list of patent claims	Composition;

Drugs Protected by US Patent 12,138,271

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	AZMIRO	testosterone cypionate	SOLUTION;INTRAMUSCULAR	216318-001	Jun 2, 2022		DISCN	Yes	No			Y