Morphine sulfate - Generic Drug Details

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What are the generic 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
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
Epic Pharma Llc	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	091357-002	Jun 23, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rhodes Pharms	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	074769-001	Jul 2, 1998	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	MORPHINE SULFATE	morphine sulfate	SOLUTION;ORAL	205509-002	Apr 17, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nesher Pharms	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	076733-001	May 19, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	078761-003	May 11, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	MORPHINE SULFATE	morphine sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	204223-003	Oct 30, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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
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
China	204798475		⤷ Sign Up
Denmark	2968729		⤷ Sign Up
Australia	2014230836	Packaging system for oxygen-sensitive drugs	⤷ Sign Up
Brazil	112015021586	formulações de morfina	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2014140097		⤷ Sign Up
European Patent Office	2877161	COMPOSITIONS PHARMACEUTIQUES DE DISSUASION D'ABUS À LIBÉRATION CONTRÔLÉE (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)	⤷ 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

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