Assyro AI

FDA Orange Book · active-ingredient family

Methocarbamol

Methocarbamol is approved as 3 brand and 72 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ATMEKSI · NDA 219843

3

Brand (NDA)

72

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, suspension, tablet

ProductApplicantApplicationTEApproved
ATMEKSIRLDROSEMONT PHARMSNDA 219843—Jul 30, 2025
ROBAXINRLDHIKMANDA 011790APApproved Prior to Jan 1, 1982
ROBAXINRLD×2ENDO OPERATIONSNDA 011011—Approved Prior to Jan 1, 1982

Generic (ANDA) products (72)

ProductApplicantApplicationTEApproved
METHOCARBAMOLMIKARTANDA 212707ABJun 12, 2023
METHOCARBAMOL×2AUROBINDO PHARMA LTDANDA 213967AAFeb 09, 2023
METHOCARBAMOLBAXTER HLTHCARE CORPANDA 215065—Jul 14, 2022
METHOCARBAMOL×3BOSTALANDA 200958ABDec 06, 2021
METHOCARBAMOL×2POINTVIEW HLDINGSANDA 212623AAApr 30, 2021
METHOCARBAMOLGLANDANDA 211504APOct 26, 2018
METHOCARBAMOL×2GRANULESANDA 209312AAMay 07, 2018
METHOCARBAMOLFRESENIUS KABI USAANDA 209331APApr 17, 2018
METHOCARBAMOLNAVINTA LLCANDA 206071—Nov 24, 2017
METHOCARBAMOLSOMERSET THERAPS LLCANDA 207522APJul 31, 2017
METHOCARBAMOL×2REGCON HOLDINGSANDA 208507AAJul 21, 2017
METHOCARBAMOLSAGENT PHARMS INCANDA 205404APJul 18, 2017
METHOCARBAMOLAM REGENTANDA 207496APJun 22, 2017
METHOCARBAMOL×2DBL PHARMSANDA 203550AAFeb 08, 2017
METHOCARBAMOLSLATE RUN PHARMAANDA 208116APJan 19, 2017
METHOCARBAMOLMONTEREY PHARMS LLCANDA 205354APOct 27, 2016
METHOCARBAMOLEUGIA PHARMAANDA 206128APMay 27, 2016
METHOCARBAMOLPHARMOBEDIENTANDA 204404—Dec 05, 2014
METHOCARBAMOL×2HETERO LABS LTD IIIANDA 090200AANov 06, 2009
METHOCARBAMOL×2CHARTWELL MOLECULARANDA 084756—Mar 31, 2003
METHOCARBAMOL×2ABLEANDA 040413—Mar 17, 2003
METHOCARBAMOL×2OXFORD PHARMSANDA 040489AAJan 29, 2003
METHOCARBAMOLMARSAM PHARMS LLCANDA 089849—Dec 27, 1991
METHOCARBAMOLAM THERAPANDA 089417—Feb 11, 1987
METHOCARBAMOLAM THERAPANDA 089418—Feb 11, 1987
METHOCARBAMOLPIONEER PHARMSANDA 088731—Dec 13, 1985
METHOCARBAMOLPIONEER PHARMSANDA 089082—Dec 13, 1985
METHOCARBAMOLROXANEANDA 088646—Feb 29, 1984
METHOCARBAMOLROXANEANDA 088647—Feb 29, 1984
METHOCARBAMOLASCOTANDA 087660—Oct 27, 1982
METHOCARBAMOLASCOTANDA 087661—Oct 27, 1982
METHOCARBAMOLSUPERPHARMANDA 087589—Jan 22, 1982
METHOCARBAMOLSUPERPHARMANDA 087590—Jan 22, 1982
METHOCARBAMOLDR REDDYSANDA 086459—Approved Prior to Jan 1, 1982
DELAXINFERNDALE LABSANDA 085454—Approved Prior to Jan 1, 1982
FORBAXINFOREST LABSANDA 085136—Approved Prior to Jan 1, 1982
METHOCARBAMOLAIPING PHARM INCANDA 084616—Approved Prior to Jan 1, 1982
METHOCARBAMOLAIPING PHARM INCANDA 084615—Approved Prior to Jan 1, 1982
METHOCARBAMOLANI PHARMSANDA 084277—Approved Prior to Jan 1, 1982
METHOCARBAMOLANI PHARMSANDA 084276—Approved Prior to Jan 1, 1982
METHOCARBAMOLCLONMEL HLTHCAREANDA 085961—Approved Prior to Jan 1, 1982
METHOCARBAMOLCLONMEL HLTHCAREANDA 085963—Approved Prior to Jan 1, 1982
METHOCARBAMOLHEATHERANDA 084675—Approved Prior to Jan 1, 1982
METHOCARBAMOLHEATHERANDA 084924—Approved Prior to Jan 1, 1982
METHOCARBAMOLHIKMA INTL PHARMSANDA 085159—Approved Prior to Jan 1, 1982
METHOCARBAMOLHIKMA INTL PHARMSANDA 085123—Approved Prior to Jan 1, 1982
METHOCARBAMOLIMPAX LABSANDA 084927—Approved Prior to Jan 1, 1982
METHOCARBAMOLIMPAX LABSANDA 084928—Approved Prior to Jan 1, 1982
METHOCARBAMOLINWOOD LABSANDA 085137—Approved Prior to Jan 1, 1982
METHOCARBAMOLIVAX SUB TEVA PHARMSANDA 084648—Approved Prior to Jan 1, 1982
METHOCARBAMOLIVAX SUB TEVA PHARMSANDA 084649—Approved Prior to Jan 1, 1982
METHOCARBAMOLKV PHARMANDA 085660—Approved Prior to Jan 1, 1982
METHOCARBAMOLKV PHARMANDA 085658—Approved Prior to Jan 1, 1982
METHOCARBAMOLMYLANANDA 084259—Approved Prior to Jan 1, 1982
METHOCARBAMOLMYLANANDA 084323—Approved Prior to Jan 1, 1982
METHOCARBAMOLNYLOSANDA 085033—Approved Prior to Jan 1, 1982
METHOCARBAMOL×2PRINSTON INCANDA 086988AAApproved Prior to Jan 1, 1982
METHOCARBAMOLPURACAP PHARMANDA 084231—Approved Prior to Jan 1, 1982
METHOCARBAMOLPURACAP PHARMANDA 084471—Approved Prior to Jan 1, 1982
METHOCARBAMOL×2PUREPAC PHARMANDA 085718—Approved Prior to Jan 1, 1982
METHOCARBAMOLSANDOZANDA 087283—Approved Prior to Jan 1, 1982
METHOCARBAMOLSANDOZANDA 087282—Approved Prior to Jan 1, 1982
METHOCARBAMOLSOLVAYANDA 084448—Approved Prior to Jan 1, 1982
METHOCARBAMOLSOLVAYANDA 084449—Approved Prior to Jan 1, 1982
METHOCARBAMOLSUN PHARM INDUSTRIESANDA 084488—Approved Prior to Jan 1, 1982
METHOCARBAMOLSUN PHARM INDUSTRIESANDA 084486—Approved Prior to Jan 1, 1982
METHOCARBAMOLTABLICAPSANDA 084846—Approved Prior to Jan 1, 1982
METHOCARBAMOLUPSHER SMITHANDA 087453—Approved Prior to Jan 1, 1982
METHOCARBAMOLUPSHER SMITHANDA 087454—Approved Prior to Jan 1, 1982
METHOCARBAMOL×2WATSON LABSANDA 083605—Approved Prior to Jan 1, 1982
METHOCARBAMOLWATSON LABSANDA 085180—Approved Prior to Jan 1, 1982
METHOCARBAMOLWATSON LABSANDA 085192—Approved Prior to Jan 1, 1982

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12390439Oct 09, 2044in 18 yr 7 mo
ProductU-4253

Methocarbamol — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo