Question 1

Is there a generic for Sotagliflozin?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Sotagliflozin. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Sotagliflozin?

Accepted Answer

INPEFA (NDA 216203, LEXICON PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sotagliflozin?

Accepted Answer

The Orange Book lists 3 patents against Sotagliflozin products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Sotagliflozin have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Sotagliflozin. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Sotagliflozin are approved?

Accepted Answer

Sotagliflozin is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7781577	May 04, 2028	in 1 yr 11 mo	SubstanceProductU-3628
8476413	May 29, 2028	in 2 yr	SubstanceProductU-3628
8217156	Oct 07, 2030	in 4 yr 4 mo	SubstanceProduct

Sotagliflozin

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (3)

Sotagliflozin — frequently asked questions

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