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Last Updated: March 1, 2024

MORPHINE SULFATE Drug Patent Profile


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When do Morphine Sulfate patents expire, and when can generic versions of Morphine Sulfate launch?

Morphine Sulfate is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Nortec Dev Assoc, Strides Pharma, Teva Pharms Usa, Upsher Smith Labs, Hikma, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms, Chartwell Molecular, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Alkem Labs Ltd, Ingenus Pharms Nj, and Meridian Medcl Techn. and is included in sixty-two NDAs. There are three patents protecting this drug.

This drug has twenty-four patent family members in eleven countries.

The generic ingredient in MORPHINE SULFATE is morphine sulfate. There are twenty-three drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Morphine Sulfate

A generic version of MORPHINE SULFATE was approved as morphine sulfate by HOSPIRA on May 11th, 1988.

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Drug patent expirations by year for MORPHINE SULFATE
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
Instituto Nacional de Cancer, BrazilPhase 2
Beni-Suef UniversityPhase 2
Cairo UniversityPhase 4

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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

MORPHINE SULFATE is protected by four US patents and one FDA Regulatory Exclusivity.

Patents protecting MORPHINE SULFATE

Morphine formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Morphine formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Morphine formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN

Packaging system for oxygen-sensitive drugs
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Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting MORPHINE SULFATE

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Exclusivity Expiration: ⤷  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
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-001 Oct 30, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Nostrum Labs Inc MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 201011-003 Oct 6, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 211452-001 Jan 12, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 202718-005 Dec 29, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 205634-002 Aug 25, 2016 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for MORPHINE SULFATE

See the table below for patents covering MORPHINE SULFATE around the world.

Country Patent Number Title Estimated Expiration
China 104528165 Packaging system for oxygen-sensitive drugs ⤷  Try a Trial
Hong Kong 1208015 用於氧敏感藥物的包裝系統 (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) ⤷  Try a Trial
European Patent Office 3424547 SYSTÈME D'EMBALLAGE POUR MÉDICAMENTS SENSIBLES À L'OXYGÈNE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) ⤷  Try a Trial
Portugal 2968729 ⤷  Try a Trial
Denmark 2968729 ⤷  Try a Trial
Japan 6215970 ⤷  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.