Viewing data from:

INPEFA

NDA

SOTAGLIFLOZIN | N216203 | LEXICON PHARMACEUTICALS INC

2 strengths3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivity

2027

2028

2029

2030

Today

7781577

May. 4, 2028

8217156

Oct. 7, 2030

8476413

May. 29, 2028

NCE

May. 26, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients NCT05562063	Phase 4	Completed	Juan Badimon	88	2022-10-26 → 2025-06-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Inpefa (2023)

Total Spending

$659K

Total Claims

711

Beneficiaries

405

Avg Cost/Unit

$21.00

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

LEE PHARMA LTDSOTAGLIFLOZIN

DMF 412492025

ALP PHARM BEIJING CO LTDSOTAGLIFLOZIN

DMF 418512025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 30, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG

RLD

3 patents1 exclusivity▴

TABLET;ORAL | Approved: May 26, 2023

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7781577	May 4, 2028	—	Yes	Yes		—
8217156	Oct 7, 2030	—	Yes	Yes	—	—
8476413	May 29, 2028	—	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
NCE	May 26, 2028	Active

#002 — 400MG

RLD

3 patents1 exclusivity▾

TABLET;ORAL | Approved: May 26, 2023