small molecule

ZEPBOUND

TIRZEPATIDE

Loss of exclusivityJuly 2039latest FDA-listed patent expiry

CompanyELI LILLY AND CO

Drug detail

Brand name	ZEPBOUND
Active ingredient	TIRZEPATIDE
Strength	2.5MG/0.5ML (2.5MG/0.5ML)
Dosage form	SOLUTION
Route	SUBCUTANEOUS
Modality	Small molecule
FDA approval	March 2024
Marketing status	RX

Listed patents

Patent	Expires	Type
12453758	July 2039	use U-4308
12616740	July 2039	use U-4499
12343382	July 2039	use U-4409
11357820	June 2039	product
12453756	June 2039	product
11918623	June 2039	use U-3855
12629404	June 2039	product
9474780	January 2036	substance, product

Regulatory exclusivity

Code	Expires
I-958	December 2027
M-82	October 2027
NCE	May 2027

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

Drug detail

Listed patents

Regulatory exclusivity

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