Viewing data from:

STEGLATRO

NDA

ERTUGLIFLOZIN | N209803 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

Today

8080580

Dec. 19, 2031

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Merck Sharp & Dohme Corp. et al v. Hetero Labs Limited et al 1:2022cv00378 1 patentANDA 217071ertugliflozin	D. Del.	2022-03-23	Terminated 2023-05-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction NCT07621380	Phase 4	Not Yet Recruiting	Shanghai Zhongshan Hospital	476	2026-07-01 → 2028-03-01

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

Medicare Part D Spending

CMS annual spending data for Steglatro (2023)

Total Spending

$18.2M

Total Claims

36,893

Beneficiaries

11,552

Avg Cost/Unit

$11.44

Spending Trend

$5.5M(2019)→$11.4M(2020)→$15.0M(2021)→$17.3M(2022)→$18.2M(2023)

YoY Change:+6.4%

5yr CAGR:+5.3%

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

API Supply Chain7 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

HIKAL LTDERTUGLIFLOZIN L-PYROGLUTAMIC ACID

DMF 348502020

MSN LABORATORIES PRIVATE LTDERTUGLIFLOZIN

DMF 357872021

BIOPHORE INDIA PHARMACEUTICALS PVT LTDERTUGLIFLOZIN L-PYROGLUTAMIC ACID

DMF 359912021

APITORIA PHARMA PRIVATE LTDERTUGLIFLOZIN L-PYROGLUTAMIC ACID

DMF 361522021

HONOUR LAB LIMITEDERTUGLIFLOZIN L-PYROGLUTAMIC ACID

DMF 362832021

MSN LABORATORIES PRIVATE LTDERTUGLIFLOZIN L-PYROGLUTAMIC ACID

DMF 369392022

MOREPEN LABORATORIES LTDERTUGLIFLOZIN L-PYROGLUTAMATE

DMF 373592022

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jun 5, 2026	SUPPL -12	View Letter (PDF)
Dec 27, 2024	SUPPL -8	View Letter (PDF)
Sep 13, 2023	SUPPL -7	View Letter (PDF)
Oct 14, 2022	SUPPL -6	View Letter (PDF)
Sep 21, 2021	SUPPL -4	View Letter (PDF)
Jan 27, 2020	SUPPL -2	View Letter (PDF)
Oct 30, 2018	SUPPL -1	View Letter (PDF)
Dec 27, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Dec 19, 2017

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8080580	Dec 19, 2031	—	Yes	Yes		—

#002 — 15MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Dec 19, 2017