small molecule

AUGTYRO

REPOTRECTINIB

Loss of exclusivityJuly 2036latest FDA-listed patent expiry

CompanyBRISTOL MYERS SQUIBB CO

Drug detail

Brand name	AUGTYRO
Active ingredient	REPOTRECTINIB
Strength	160MG
Dosage form	CAPSULE
Route	ORAL
Modality	Small molecule
FDA approval	June 2024
Marketing status	RX

Listed patents

Patent	Expires	Type
11452725	July 2036	use U-3961
12310968	July 2036	use U-3755
10294242	July 2036	substance
12187739	July 2036	product
RE50634	January 2035	substance, product

Regulatory exclusivity

Code	Expires
ODE-483	June 2031
ODE*	November 2030
NCE	November 2028

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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