MORPHINE SULFATE - Generic Drug Details

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What are the generic drug sources for morphine sulfate and what is the scope of freedom to operate?

Morphine sulfate is the generic ingredient in fourteen branded drugs marketed by King Pharms Llc, Allergan, Actavis Elizabeth, Impax Labs Inc, Nortec Dev Assoc, Strides Pharma, Teva Pharms Usa, Upsher Smith Labs, Pacira Pharms Inc, Fresenius Kabi Usa, Hikma, Piramal Critical, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Meridian Medcl Techn, Ani Pharms, Chartwell Molecular, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Zyla, Ohemo Life, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Purdue Pharma Lp, Xanodyne Pharms Inc, Alkem Labs Ltd, Ingenus Pharms Nj, and Alpharma Pharms, and is included in seventy-six NDAs. There are sixteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate has fifty-nine patent family members in sixteen countries.

There are twelve drug master file entries for morphine sulfate. Thirty-one suppliers are listed for this compound.

Summary for MORPHINE SULFATE

International Patents:	59
US Patents:	16
Tradenames:	14
Applicants:	43
NDAs:	76
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	199
Patent Applications:	6,913
Drug Prices:	Drug price trends 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

See drug prices for MORPHINE SULFATE

Drug Sales Revenue Trends for MORPHINE SULFATE

See drug sales revenues for MORPHINE SULFATE

Recent Clinical Trials for MORPHINE SULFATE

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

Sponsor	Phase
University of Calgary	Phase 3
Canadian Institutes of Health Research (CIHR)	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

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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
Hikma	MORPHINE SULFATE	morphine sulfate	SOLUTION;ORAL	022195-002	Mar 17, 2008	AA	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-003	Jan 9, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Nesher Pharms	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	076720-001	May 19, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	MORPHINE SULFATE	morphine sulfate	TABLET;ORAL	212451-002	Dec 3, 2020	AB	RX	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

Expired US Patents for MORPHINE SULFATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-003	May 18, 2004	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-002	May 18, 2004	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-003	May 18, 2004	⤷ Sign Up	⤷ Sign Up
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-005	Mar 9, 2001	⤷ Sign Up	⤷ Sign Up
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-002	Jul 3, 1996	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-003	May 18, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MORPHINE SULFATE

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1208015	用於氧敏感藥物的包裝系統 (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)	⤷ Sign Up
Canada	2696341	MEDICAMENTS RESISTANT AUX ABUS, PROCEDES D'UTILISATION ET DE FABRICATION (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING)	⤷ Sign Up
European Patent Office	2877161	COMPOSITIONS PHARMACEUTIQUES DE DISSUASION D'ABUS À LIBÉRATION CONTRÔLÉE (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)	⤷ Sign Up
Spain	2695158		⤷ Sign Up
China	104042565	Morphine Formulations, Kits Comprising The Morphine Formulations And Use Thereof	⤷ Sign Up
Japan	2015521988	制御放出用乱用防止性医薬組成物	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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