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ROBAXIN

NDA

METHOCARBAMOL | N011011 | ENDO OPERATIONS LTD

2 strengths0 unique patents0 unique exclusivities

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Granules India Limited FDA-2023-P-0576 Granules India Limited submitted this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to file an ANDA for Methocarbamol Capsules in 500 mg and 750 mg strengths, which would differ from the reference listed drug Robaxin Methocar	Suitability	2023-02-21	Open	Granules India Limited

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)NCT06264310	Phase 2	Completed	River 2 Renal Corp.	33	2024-03-01 → 2024-11-25

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

Medicare Part D Spending

CMS annual spending data for Methocarbamol* (2023)

Total Spending

$32.6M

Total Claims

2,514,312

Beneficiaries

1,036,252

Avg Cost/Unit

$0.17

Spending Trend

$12.3M(2019)→$17.9M(2020)→$21.6M(2021)→$27.1M(2022)→$32.6M(2023)

YoY Change:+0.6%

5yr CAGR:+1.1%

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

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

3 letters from Drugs@FDA

Date	Submission	Document
Jun 11, 2020	SUPPL -79	View Letter (PDF)
May 1, 2003	SUPPL -70	View Letter (PDF)
May 1, 2003	SUPPL -71	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#004 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#006 — 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982