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. Thirty-one 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 September 30^th, 1992.

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Summary for MORPHINE SULFATE

International Patents:	24
US Patents:	3
Applicants:	34
NDAs:	62
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	199
Patent Applications:	4,205
Drug Prices:	Drug price information for MORPHINE SULFATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MORPHINE SULFATE
What excipients (inactive ingredients) are in MORPHINE SULFATE?	MORPHINE SULFATE excipients list
DailyMed Link:	MORPHINE SULFATE at DailyMed

Drug patent expirations by year for MORPHINE SULFATE

Recent Clinical Trials for MORPHINE SULFATE

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

Sponsor	Phase
Canadian Institutes of Health Research (CIHR)	Phase 3
University of Calgary	Phase 3
Instituto Nacional de Cancer, Brazil	Phase 2

See all MORPHINE SULFATE clinical trials

Pharmacology for MORPHINE SULFATE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for MORPHINE SULFATE

Analgesics, Opioid
Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for MORPHINE SULFATE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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
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Patent Expiration: ⤷ Sign Up

Morphine formulations
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Patented Use: MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Morphine formulations
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Patented Use: TREATMENT OF PAIN

Packaging system for oxygen-sensitive drugs
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FDA Regulatory Exclusivity protecting MORPHINE SULFATE

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Nostrum Labs Inc	MORPHINE SULFATE	morphine sulfate	SOLUTION;ORAL	201011-003	Oct 6, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	211452-001	Jan 12, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	202718-005	Dec 29, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	205634-002	Aug 25, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2018236914	PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS	⤷ Sign Up
Japan	6215970		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2014140097		⤷ Sign Up
China	104042565	Morphine Formulations, Kits Comprising The Morphine Formulations And Use Thereof	⤷ Sign Up
European Patent Office	2968729	SYSTÈME D'EMBALLAGE POUR MÉDICAMENTS SENSIBLES À L'OXYGÈNE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration