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Last Updated: August 15, 2022

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, Akorn, Ani Pharms, Chartwell Molecular, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Zyla, Daiichi Sankyo Inc, Dava Pharms Inc, Epic Pharma Llc, Mayne Pharma Inc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Purdue Pharma Lp, Xanodyne Pharms Inc, Alkem Labs Ltd, Riconpharma Llc, and Alpharma Pharms, and is included in seventy-four 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-three 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

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SponsorPhase
University of ChicagoPhase 4
NEMA Research, Inc.Phase 3
Lyndra Inc.Phase 1

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Pharmacology for morphine sulfate
Drug Class Opioid 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 MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-005 Oct 30, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Upsher Smith Labs MORPHINE SULFATE morphine sulfate TABLET;ORAL 210610-001 Jul 22, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Upsher Smith Labs MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 202104-005 Jun 3, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021671-003 May 18, 2004 See Plans and Pricing See Plans and Pricing
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 See Plans and Pricing See Plans and Pricing
King Pharms Llc AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260-004 Mar 20, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for morphine sulfate

Country Patent Number Title Estimated Expiration
Canada 2902346 SYSTEME DE CONDITIONNEMENT POUR MEDICAMENTS SENSIBLES A L'OXYGENE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) See Plans and Pricing
Australia 2018236914 PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS See Plans and Pricing
European Patent Office 2877161 COMPOSITIONS PHARMACEUTIQUES DE DISSUASION D'ABUS À LIBÉRATION CONTRÔLÉE (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
Express Scripts
McKesson
Baxter
Mallinckrodt

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.