Is Lexicon Pharmaceuticals, Inc. FDA approved?

Lexicon Pharmaceuticals, Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Lexicon Pharmaceuticals, Inc. make?

4 products are listed under Lexicon Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Lexicon Pharmaceuticals, Inc.

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

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Registered sites: 0
Active NDC listings: 4
Live patents: 6
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
tablet	4

Route	NDCs
oral	4

Labeller name on the listing	NDCs
lexicon pharmaceuticals, inc.	4

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7781577	INPEFAsotagliflozin	substance, product	May 2028
8476413	INPEFAsotagliflozin	substance, product	May 2028
8217156	INPEFAsotagliflozin	substance, product	Oct 2030

Product	Exclusivity	Until
INPEFASOTAGLIFLOZIN	NCE New chemical entity	May 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
INPEFA	sotagliflozin	tablet, oral	70183-220NDA
INPEFA	sotagliflozin	tablet, oral	70183-221NDA
INPEFA	sotagliflozin	tablet, oral	70183-241NDA
Xermelo	telotristat ethyl	tablet, oral	70183-125NDA

Enquiry

Common questions

Is Lexicon Pharmaceuticals, Inc. FDA approved?: Lexicon Pharmaceuticals, Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Lexicon Pharmaceuticals, Inc. make?: 4 products are listed under Lexicon Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet. 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.