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Last Updated: December 7, 2022

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, Akorn, Ani Pharms, Chartwell Molecular, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Dava Pharms Inc, Epic Pharma Llc, Mayne Pharma Inc, 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 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. Thirty-four 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

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

SponsorPhase
Cairo UniversityPhase 4
University of ChicagoPhase 4
NEMA Research, Inc.Phase 3

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
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Morphine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Morphine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN

Packaging system for oxygen-sensitive drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting MORPHINE SULFATE

NEW PATIENT POPULATION
Exclusivity Expiration: 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
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-003 Oct 30, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rhodes Pharms MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 206308-002 Jun 22, 2017 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 205758-001 May 21, 2015 AP RX No 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

International Patents for MORPHINE SULFATE

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

Country Patent Number Title Estimated Expiration
European Patent Office 2968132 FORMULATION DE MORPHINE INJECTABLE (INJECTABLE MORPHINE FORMULATIONS) See Plans and Pricing
China 109125254 吗啡调配物、包含所述吗啡调配物的试剂盒和其用途 (Morphine Formulations, Kits Comprising The Morphine Formulations And Use Thereof) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2014140095 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.