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Last Updated: March 28, 2024

Morphine sulfate - Generic Drug Details


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What are the generic drug 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, 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
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
Specgx Llc MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 020631-002 Jul 3, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xanodyne Pharms Inc ORAMORPH SR morphine sulfate TABLET, EXTENDED RELEASE;ORAL 019977-002 Aug 15, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 200411-005 Apr 12, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076412-003 Jul 31, 2003 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 071850-001 May 11, 1988 DISCN No 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
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-005 Mar 9, 2001 ⤷  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 021671-003 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
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-002 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
Japan 2016512210 注射可能なモルヒネ製剤 ⤷  Try a Trial
Mexico 336789 FARMACOS RESISTENTES AL ABUSO, METODO DE USO Y METODO DE FABRICACION. (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2014006004 ⤷  Try a Trial
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) ⤷  Try a Trial
European Patent Office 3143988 FORMULATIONS INJECTABLES À BASE DE MORPHINE (INJECTABLE MORPHINE FORMULATIONS) ⤷  Try a Trial
>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.