small molecule

OPFOLDA

MIGLUSTAT

Loss of exclusivitySeptember 2038latest FDA-listed patent expiry

CompanyAmicus Therapeutics →See this company's full patent-cliff portfolio

Drug detail

Brand name	OPFOLDA
Active ingredient	MIGLUSTAT
Strength	65MG
Dosage form	CAPSULE
Route	ORAL
Modality	Small molecule
FDA approval	September 2023
Marketing status	RX

Listed patents

Patent	Expires	Type
12246062	September 2038	use U-3726
10857212	August 2037	use U-3726
11278601	December 2036	product
12414985	December 2036	use U-3726
11753632	September 2035	use U-3726
10208299	September 2035	substance, product
10961522	September 2035	use U-3726
11278599	March 2033	use U-3726
12419937	March 2033	use U-3726
10512677	March 2033	use U-3726

Regulatory exclusivity

Code	Expires
NP	September 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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