Viewing data from:

ATMEKSI

NDA

METHOCARBAMOL | N219843 | ROSEMONT PHARMACEUTICALS HOLDINGS INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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Today

12390439

Oct. 9, 2044

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 Chain10 active DMFs20 inactive

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

BOEHRINGER INGELHEIM CHEMICALS INCMETHOCARBAMOL

DMF 59541985

SYNTHOKEM LABS PRIVATE LTDMETHOCARBAMOL USP

DMF 104101993

SEVEN STAR PHARMACEUTICAL CO LTDMETHOCARBAMOL

DMF 155962001

GRANULES INDIA LTDMETHOCARBAMOL USP

DMF 178722004

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDMETHOCARBAMOL API

DMF 196572006

ZHEJIANG HAIZHOU PHARMACEUTICAL CO LTDMETHOCARBAMOL USP

DMF 311122016

ZHEJIANG HAIZHOU PHARMACEUTICAL CO LTDMETHOCARBAMOL

DMF 336592019

ZHEJIANG HAIZHOU PHARMACEUTICAL CO LTDMETHOCARBAMOL (PROCESS ISOPROPANOL)

DMF 374362023

DELTA SYNTHETIC CO LTDMETHOCARBAMOL

DMF 386312023

APITORIA PHARMA PRIVATE LTDMETHOCARBAMOL USP

DMF 426542025

PENCO OF LYNDHURST INCInactiveMETHOCARBAMOL

DMF 2321956

CHRISTIAN BRUNNENGRABER AND COInactiveMETHOCARBAMOL

DMF 8661964

ORION CORP FERMIONInactiveMETHOCARBAMOL NF XV

DMF 40361980

TIANJIN MEDICINES & HEALTH PRODUCTS IMPORT AND EXPORT COInactiveMETHOCARBAMOL

DMF 41101981

ORGAMOL SAInactiveMETHOCARBAMOL

DMF 48281983

EASTMAN CHEMICAL COInactiveMETHOCARBAMOL USP

DMF 49801983

SYNTHAInactiveMETHOCARBAMOL

DMF 51361983

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveMETHOCARBAMOL

DMF 53741984

OMNICHEM NVInactiveMETHOCARBAMOL USP

DMF 56671985

ORION CORP LTDInactiveMETHOCARBAMOL

DMF 63891985

HEXAGON LABORATORIES INCInactiveMETHOCARBAMOL

DMF 64681986

LASA LABORATORIOS SAInactiveMETHOCARBAMOL

DMF 66421986

CIPLA LTDInactiveMETHOCARBAMOL

DMF 67051986

PENCO OF LYNDHURST INCInactiveMETHOCARBAMOL

DMF 67731987

SIANG TA PHARMACEUTICAL CO LTDInactiveMETHOCARBAMOL

DMF 108331994

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveMETHOCARBAMOL USP

DMF 130801998

BIDACHEM SPAInactiveMETHOCARBAMOL

DMF 149062000

BENTLEY API SLInactiveMETHOCARBAMOL

DMF 158752002

SEVEN STAR PHARMACEUTICAL CO LTDInactiveMETHOCARBAMOL DC 90%

DMF 202752007

ZHEJIANG JIANFENG HAIZHOU PHARMACEUTICAL CO LTDInactiveMETHOCARBAMOL

DMF 267682012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 1, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 750MG/5ML

RLD

1 patent0 exclusivities▴

SUSPENSION;ORAL | Approved: Jul 30, 2025

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12390439	Oct 9, 2044	—	—	Yes		—

Change History (1)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Rosemont Pharmaceuticals updated its registered applicant name from Rosemont Pharmaceuticals Inc to Rosemont Pharmaceuticals Holdings Inc for methocarbamol (Atmeksi, NDA 219843).

Old: ROSEMONT PHARMACEUTICALS INC

New: ROSEMONT PHARMACEUTICALS HOLDINGS INC