small molecule

LUMAKRAS

SOTORASIB

Loss of exclusivitySeptember 2040latest FDA-listed patent expiry

CompanyAmgen →See this company's full patent-cliff portfolio

Drug detail

Brand name	LUMAKRAS
Active ingredient	SOTORASIB
Strength	120MG
Dosage form	TABLET
Route	ORAL
Modality	Small molecule
FDA approval	May 2021
Marketing status	RX

Listed patents

Patent	Expires	Type
11426404	September 2040	use U-4107
12398133	May 2040	substance, product
11236091	May 2040	substance, product
11827635	May 2040	substance, product
12280056	November 2039	use U-4107
10519146	May 2038	substance, product

Regulatory exclusivity

Code	Expires
ODE-507	January 2032
ODE-352	May 2028
I-962	January 2028
NCE	May 2026

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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