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Last Updated: August 14, 2020

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MORPHINE SULFATE Drug 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, Par Pharm Inc, Teva Pharms Usa, Upsher Smith Labs, Hikma, Hospira, Hospira Inc, Icu Medical Inc, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms Inc, Hi Tech, Lannett Co Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, 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, and Meridian Medcl Techn. and is included in fifty-four 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. Forty suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

US ANDA 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
Royal Brompton & Harefield NHS Foundation TrustPhase 3
Eric AlbrechtN/A
M.D. Anderson Cancer CenterPhase 3

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 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 204223-005 Oct 30, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Actavis Elizabeth MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 203849-002 Apr 6, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Hospira MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 073510-001 Sep 30, 1992 AP RX No No   Start Trial   Start Trial   Start Trial
Upsher Smith Labs MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 202104-005 Jun 3, 2013 AB RX No No   Start Trial   Start Trial   Start 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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