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ERTUGLIFLOZIN

ANDA

ERTUGLIFLOZIN | A217071 | HETERO LABS LTD UNIT V

2 strengths0 unique patents0 unique exclusivities

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).

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

1 letter from Drugs@FDA

Date	Submission	Document
May 31, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 17, 2024

No patent or exclusivity listings for this strength.

#002 — 15MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 17, 2024