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

35 trials from ClinicalTrials.gov, 28 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin NCT03066830	Phase 3	Completed	Lexicon Pharmaceuticals	507	2017-02-24 → 2019-04-30
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy NCT02384941	Phase 3	Completed	Lexicon Pharmaceuticals	793	2015-03 → 2017-02
Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects NCT03310944	Phase 1	Completed	Sanofi	12	2017-10-18 → 2017-12-08
Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin NCT03063580	Phase 1	Completed	Sanofi	16	2017-02-27 → 2017-05-12
Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents NCT03285594	Phase 3	Completed	Lexicon Pharmaceuticals	571	2017-09-15 → 2019-09-27
Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin NCT03351478	Phase 3	Completed	Lexicon Pharmaceuticals	770	2017-11-27 → 2019-05-16
Sotagliflozin Bioequivalence Study NCT03211195	Phase 1	Completed	Sanofi	76	2017-06-29 → 2017-08-22
Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin NCT02926950	Phase 3	Completed	Lexicon Pharmaceuticals	518	2016-11 → 2019-03-22
Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension NCT03462069	Phase 2	Completed	Sanofi	41	2018-03-12 → 2019-04-18
Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects NCT03909451	Phase 1	Completed	Sanofi	24	2019-04-28 → 2019-08-19

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$20.50

per ea

Lowest NADAC/Unit

$20.50

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70183022130INPEFA 200 MG TABLET	$20.50	EA	Brand	—	2026-06-17
70183022131INPEFA 200 MG TABLET	$20.50	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$309.52

Highest Price

$309.52

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70183-0220-30INPEFA 200MG TAB	$309.52	FSS	Lexicon Pharmaceuticals, Inc.	01/14/2029
70183-0220-30INPEFA 200MG TAB	$309.52	Big4	Lexicon Pharmaceuticals, Inc.	01/14/2029
70183-0221-30INPEFA 200MG TAB	$309.52	FSS	Lexicon Pharmaceuticals, Inc.	01/14/2029
70183-0221-30INPEFA 200MG TAB	$309.52	Big4	Lexicon Pharmaceuticals, Inc.	01/14/2029
70183-0221-31INPEFA 200MG TAB	$309.52	FSS	Lexicon Pharmaceuticals, Inc.	01/14/2029
70183-0221-31INPEFA 200MG TAB	$309.52	Big4	Lexicon Pharmaceuticals, Inc.	01/14/2029
70183-0241-30INPEFA 400MG TAB	$309.52	FSS	Lexicon Pharmaceuticals, Inc.	01/14/2029
70183-0241-30INPEFA 400MG TAB	$309.52	Big4	Lexicon Pharmaceuticals, Inc.	01/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Inpefa (2024)

Total Spending

$5.9M

Total Claims

7,368

Beneficiaries

2,006

Avg Cost/Unit

$19.33

Spending Trend

$659K(2023)→$5.9M(2024)

YoY Change:-8.0%

5yr CAGR:-8.0%

Source: CMS Medicare Part D Spending by Drug (2024). 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) · 2 use codes

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