small molecule

LYBALVI

OLANZAPINE; SAMIDORPHAN L-MALATE

Loss of exclusivityNovember 2041latest FDA-listed patent expiry

CompanyALKERMES INC

Drug detail

Brand name	LYBALVI
Active ingredient	OLANZAPINE; SAMIDORPHAN L-MALATE
Strength	15MG;EQ 10MG BASE
Dosage form	TABLET
Route	ORAL
Modality	Small molecule
FDA approval	May 2021
Marketing status	RX

Listed patents

Patent	Expires	Type
11951111	November 2041	use U-3887
12390474	November 2041	product
11707466	November 2041	product
10300054	May 2033	product
8778960	February 2032	use U-3137
9119848	August 2031	substance
11241425	August 2031	use U-3137
10716785	August 2031	use U-3136
9126977	August 2031	product
12194035	August 2031	use U-3141
11185541	August 2031	use U-3140
11793805	August 2031	use U-3734
11351166	August 2031	use U-3141
9517235	August 2031	use U-3138

Regulatory exclusivity

Code	Expires
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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