MOUNJARO - (2.5 mg/0.5 mL, 5mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 15 mg/0.5 mL ; Subcutaneous Solution)

Generic Name	TIRZEPATIDE	Innovator	Eli Lilly
Dosage	2.5 mg/0.5 mL, 5mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 15 mg/0.5 mL ; Subcutaneous Solution	Branded US Sales	More Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	MOUNJARO® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events

MOUNJARO - (12.5 mg/0.5 mL ; Subcutaneous Solution)

Generic Name	TIRZEPATIDE	Innovator	Eli Lilly
Dosage	12.5 mg/0.5 mL ; Subcutaneous Solution	Branded US Sales	More Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	MOUNJARO® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
** *****'*	*** \ *********	*** **, ****	*******	****	*** ****** *** ****
*** ****	** \ **	*** **, ****	*******	****	*** ****** *** ****

Chronology Of Events