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Last Updated: January 30, 2023

Morphine sulfate - Generic Drug Details


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What are the generic sources for morphine sulfate and what is the scope of patent protection?

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, Ingenus Pharms Nj, 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-seven 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
Beni-Suef UniversityPhase 2
Cairo UniversityPhase 4
University of ChicagoPhase 4

See all morphine sulfate clinical trials

Pharmacology for morphine sulfate
Drug Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories 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
Actavis Elizabeth MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 203849-003 Apr 6, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Industries MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 205634-005 Aug 25, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nesher Pharms MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076720-001 May 19, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-006 Aug 13, 2009 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-007 Feb 27, 2007 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira Inc MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 202515-001 Nov 14, 2011 RX Yes Yes 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 021671-001 May 18, 2004 See Plans and Pricing See Plans and Pricing
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-002 Jul 3, 1996 See Plans and Pricing See Plans and Pricing
King Pharms Llc AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260-003 Mar 20, 2002 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
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-007 Feb 27, 2007 See Plans and Pricing See Plans and Pricing
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-003 May 18, 2004 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
South Korea 20150059167 제어된 방출을 위한 남용 제지 약학적 조성물 (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE) See Plans and Pricing
Australia 2014230834 Injectable morphine formulations See Plans and Pricing
Japan 2016512210 注射可能なモルヒネ製剤 See Plans and Pricing
Hong Kong 1208015 用於氧敏感藥物的包裝系統 (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) See Plans and Pricing
Japan 2016138126 乱用抵抗性医薬組成物、その使用方法および作製方法 (ABUSE RESISTANT PHARMACEUTICAL COMPOSITIONS, METHOD OF USING AND PRODUCING THEREOF) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009023672 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.