Is Rhythm Pharmaceuticals, Inc FDA approved?

Rhythm Pharmaceuticals, Inc holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Rhythm Pharmaceuticals, Inc make?

1 product is listed under Rhythm Pharmaceuticals, Inc in the openFDA NDC Directory, most often as solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Rhythm Pharmaceuticals, Inc

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 3
Exclusivities: 1
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
9458195	IMCIVREEsetmelanotide acetate	substance, product	Oct 2027
8039435	IMCIVREEsetmelanotide acetate	substance, product	Aug 2032
11129869	IMCIVREEsetmelanotide acetate	product	Jul 2034

Product	Exclusivity	Until
IMCIVREESETMELANOTIDE ACETATE	ODE-508 Orphan drug	Dec 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Imcivree	setmelanotide	solution, subcutaneous	72829-010NDA

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Common questions

Is Rhythm Pharmaceuticals, Inc FDA approved?: Rhythm Pharmaceuticals, Inc holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Rhythm Pharmaceuticals, Inc make?: 1 product is listed under Rhythm Pharmaceuticals, Inc in the openFDA NDC Directory, most often as solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.