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	10MG/2.4ML (4.17MG/ML)
Dosage form	SOLUTION
Route	SUBCUTANEOUS
Modality	Small molecule
FDA approval	January 2026
Marketing status	RX

Listed patents

Patent	Expires	Type
12343382	July 2039	use U-4410
12453758	July 2039	use U-4311
12616740	July 2039	use U-4499
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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