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Last Updated: September 16, 2021

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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, Par Pharm Inc, 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, Lannett Co Inc, 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, Mylan Pharms Inc, Nesher Pharms, Novel Labs Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Vintage Pharms Llc, Alkem Labs Ltd, and Meridian Medcl Techn. and is included in fifty-eight 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-six 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
Chiang Mai UniversityPhase 4
University of UtahPhase 2
Seoul National University HospitalN/A

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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 NDA Submissiondate
MORPHABOND ER TABLET, EXTENDED RELEASE;ORAL morphine sulfate 206544 2019-01-28
ARYMO ER TABLET, EXTENDED RELEASE;ORAL morphine sulfate 208603 2017-12-29
AVINZA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate 021260 2009-08-11
AVINZA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate 021260 2009-07-30
AVINZA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate 021260 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 204223-003 Oct 30, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Rhodes Pharms MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 206308-002 Jun 22, 2017 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 205758-001 May 21, 2015 AP RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Baxter
Colorcon
Express Scripts
McKinsey

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