Morphine sulfate - Generic Drug Details

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 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:	30
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	198
Patent Applications:	6,233
Formulation / Manufacturing:	see details
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

See drug sales revenues for morphine sulfate

Recent Clinical Trials for morphine sulfate

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

Sponsor	Phase
Instituto Nacional de Cancer, Brazil	Phase 2
Beni-Suef University	Phase 2
Cairo University	Phase 4

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Industries	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	205634-003	Aug 25, 2016		DISCN	No	No
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009		DISCN	Yes	No			Y
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009		DISCN	Yes	No
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-005	Mar 9, 2001		DISCN	Yes	No
Specgx Llc	MORPHINE SULFATE	morphine sulfate	TABLET;ORAL	215194-001	Aug 21, 2023	AB	RX	No	No
Nortec Dev Assoc	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	203158-002	Aug 4, 2021		DISCN	No	No
Xanodyne Pharms Inc	ORAMORPH SR	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	019977-002	Aug 15, 1991		DISCN	No	No

Expired US Patents for morphine sulfate

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
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-003	May 18, 2004
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-002	May 18, 2004
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-003	May 18, 2004
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-001	May 18, 2004
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-001	May 18, 2004
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-001	Jul 3, 1996

International Patents for morphine sulfate

Country	Patent Number	Title	Estimated Expiration
Canada	2734075	COMPOSITIONS PHARMACEUTIQUES CONFIGUREES POUR DISSUADER LE FRACTIONNEMENT DES FORMES POSOLOGIQUES (PHARMACEUTICAL COMPOSITIONS CONFIGURED TO DETER DOSAGE FORM SPLITTING)
European Patent Office	2331080	COMPOSITIONS PHARMACEUTIQUES CONFIGURÉES POUR DISSUADER LE FRACTIONNEMENT DES FORMES POSOLOGIQUES (PHARMACEUTICAL COMPOSITIONS CONFIGURED TO DETER DOSAGE FORM SPLITTING)
Brazil	PI0815387	composição farmacêutica, método para fazer uma composição farmacêutica e método de tratar uma condição
European Patent Office	2187873	MÉDICAMENTS RÉSISTANT AUX ABUS, PROCÉDÉS D'UTILISATION ET DE FABRICATION (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING)
Spain	2692437
European Patent Office	2968132	FORMULATION DE MORPHINE INJECTABLE (INJECTABLE MORPHINE FORMULATIONS)
Japan	5965583