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NDA

FOSAPREPITANT DIMEGLUMINE | N216686 | STERISCIENCE PTE LTD

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

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2038

2039

Today

11065265

Jan. 11, 2039

12042504

Jan. 11, 2039

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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain16 active DMFs2 inactive

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

HETERO DRUGS LTDFOSAPREPITANT DIMEGLUMINE

DMF 256142011

MSN LABORATORIES PRIVATE LTDFOSAPREPITANT DIMEGLUMINE [ROUTE CODE - "FD"]

DMF 256822012

ALIVUS LIFE SCIENCES LTDFOSAPREPITANT DIMEGLUMINE

DMF 289922015

WOCKHARDT BIO AGFOSAPREPITANT DIMEGLUMINE

DMF 301372015

SCINOPHARM TAIWAN LTDFOSAPREPITANT DIMEGLUMINE

DMF 309732017

APITORIA PHARMA PRIVATE LTDFOSAPREPITANT DIMEGLUMINE

DMF 314702017

PIRAMAL PHARMA LTDFOSAPREPITANT DIMEGLUMINE

DMF 314842017

NAVINTA LLCFOSAPREPITANT DIMEGLUMINE

DMF 331052018

SHANDONG ANXIN PHARMACEUTICAL CO LTDFOSAPREPITANT DIMEGLUMINE (NON-STERILE API)

DMF 331422018

VIWIT PHARMACEUTICAL CO LTDFOSAPREPITANT DIMEGLUMINE

DMF 335582019

WISDOM PHARMACEUTICAL CO LTDFOSAPREPITANT DIMEGLUMINE

DMF 357662021

GLAND PHARMA LTDFOSAPREPITANT DIMEGLUMINE

DMF 378772023

DR REDDYS LABORATORIES LTDFOSAPREPITANT DIMEGLUMINE

DMF 382102023

MAHI DRUGS PRIVATE LTDFOSAPREPITANT DIMEGLUMINE

DMF 387312023

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFOSAPREPITANT DIMEGLUMINE

DMF 404682024

SHANDONG NEW TIME PHARMACEUTICAL CO LTDFOSAPREPITANT DIMEGLUMINE

DMF 423412025

DR REDDYS LABORATORIES LTDInactiveFOSAPREPITANT DIMEGLUMINE

DMF 248292011

WISDOM PHARMACEUTICAL CO LTDInactiveFOSAPREPITANT DIMEGLUMINE

DMF 336792019

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 31, 2026	SUPPL -4	View Letter (PDF)
May 30, 2025	SUPPL -2	View Letter (PDF)
Aug 24, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 150MG BASE/50ML (EQ 3MG BASE/ML)

RLD

2 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Aug 22, 2023

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11065265	Jan 11, 2039	—	—	Yes	—	—
12042504	Jan 11, 2039	—	—	Yes	—	—