You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Morphine sulfate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for morphine sulfate and what is the scope of freedom to operate?

Morphine sulfate is the generic ingredient in fourteen branded drugs marketed by King Pharms Llc, Allergan, Actavis Elizabeth, Impax Labs Inc, Nortec Dev Assoc, Strides Pharma, Teva Pharms Usa, Upsher Smith Labs, Pacira Pharms Inc, Fresenius Kabi Usa, Hikma, Piramal Critical, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Meridian Medcl Techn, Ani Pharms, Chartwell Molecular, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Zyla, Ohemo Life, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Purdue Pharma Lp, Xanodyne Pharms Inc, Alkem Labs Ltd, Ingenus Pharms Nj, and Alpharma Pharms, and is included in seventy-six NDAs. There are sixteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate has fifty-nine patent family members in sixteen countries.

There are twelve drug master file entries for morphine sulfate. Thirty-one suppliers are listed for this compound.

Drug Prices for morphine sulfate

See drug prices for morphine sulfate

Drug Sales Revenue Trends for morphine sulfate

See drug sales revenues for morphine sulfate

Recent Clinical Trials for morphine sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of CalgaryPhase 3
Canadian Institutes of Health Research (CIHR)Phase 3
Instituto Nacional de Cancer, BrazilPhase 2

See all morphine sulfate clinical trials

Pharmacology for morphine sulfate
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for morphine sulfate
Anatomical Therapeutic Chemical (ATC) Classes for morphine sulfate
Paragraph IV (Patent) Challenges for MORPHINE SULFATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MORPHABOND ER Extended-release Tablets morphine sulfate 15 mg, 30 mg, 60 mg and 100 mg 206544 1 2019-01-28
ARYMO ER Extended-release Tablets morphine sulfate 15 mg, 30 mg and 60 mg 208603 1 2017-12-29
AVINZA Extended-release Capsules morphine sulfate 45 mg and 75 mg 021260 1 2009-08-11
AVINZA Extended-release Capsules morphine sulfate 30 mg, 60 mg, 90 mg and 120 mg 021260 1 2007-06-04

US Patents and Regulatory Information for morphine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nesher Pharms MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076720-002 Dec 23, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rhodes Pharms MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 074862-001 Jul 7, 1998 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Specgx Llc MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076412-003 Jul 31, 2003 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma Llc MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 091357-001 Jun 23, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Industries MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 205634-001 Aug 25, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-004 Aug 13, 2009 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for morphine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-002 May 18, 2004 ⤷  Sign Up ⤷  Sign Up
King Pharms Llc AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260-006 Dec 18, 2008 ⤷  Sign Up ⤷  Sign Up
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma Lp MS CONTIN morphine sulfate TABLET, EXTENDED RELEASE;ORAL 019516-001 May 29, 1987 ⤷  Sign Up ⤷  Sign Up
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 ⤷  Sign Up ⤷  Sign Up
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-003 May 18, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for morphine sulfate

Country Patent Number Title Estimated Expiration
Denmark 2968729 ⤷  Sign Up
Japan 2015521988 制御放出用乱用防止性医薬組成物 ⤷  Sign Up
Hong Kong 1208015 用於氧敏感藥物的包裝系統 (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) ⤷  Sign Up
Canada 2923102 MEDICAMENTS RESISTANT AUX ABUS, PROCEDES D'UTILISATION ET DE FABRICATION (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING) ⤷  Sign Up
China 101801350 Abuse resistant drugs, method of use and method of making ⤷  Sign Up
Brazil 112015000150 composições farmacêuticas dissuasoras de abuso de liberação controlada ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.