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Last Updated: March 19, 2024

Morphine sulfate - Generic Drug Details


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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 suppliers are listed for this compound.

Drug Prices for morphine sulfate

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Drug Sales Revenue Trends for morphine sulfate

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Recent Clinical Trials for morphine sulfate

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

SponsorPhase
Instituto Nacional de Cancer, BrazilPhase 2
Beni-Suef UniversityPhase 2
Cairo UniversityPhase 4

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
Fresenius Kabi Usa ASTRAMORPH PF morphine sulfate INJECTABLE;INJECTION 071050-001 Oct 7, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 020631-001 Jul 3, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 075295-002 Oct 28, 1998 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 073374-001 Sep 30, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 205634-004 Aug 25, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-002 May 18, 2004 ⤷  Try a Trial ⤷  Try a Trial
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-008 Apr 20, 2007 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-002 May 18, 2004 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp MS CONTIN morphine sulfate TABLET, EXTENDED RELEASE;ORAL 019516-005 Nov 8, 1993 ⤷  Try a Trial ⤷  Try a Trial
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for morphine sulfate

Country Patent Number Title Estimated Expiration
European Patent Office 3143988 FORMULATIONS INJECTABLES À BASE DE MORPHINE (INJECTABLE MORPHINE FORMULATIONS) ⤷  Try a Trial
Denmark 2968729 ⤷  Try a Trial
Brazil 112015021586 formulações de morfina ⤷  Try a Trial
Japan 6608319 ⤷  Try a Trial
Japan 6215970 ⤷  Try a Trial
Canada 2696341 MEDICAMENTS RESISTANT AUX ABUS, PROCEDES D'UTILISATION ET DE FABRICATION (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING) ⤷  Try a Trial
China 204798475 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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