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Last Updated: April 20, 2024

MORPHINE SULFATE - Generic Drug Details

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What are the generic sources for morphine sulfate and what is the scope of patent protection?

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

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Drug Sales Revenue Trends for MORPHINE SULFATE

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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

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
Nortec Dev Assoc	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	203158-002	Aug 4, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	MORPHINE SULFATE	morphine sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	204223-001	Oct 30, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	205758-003	May 21, 2015	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Nesher Pharms	MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	076720-002	Dec 23, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-002	Mar 20, 2002	⤷ Try a Trial	⤷ Try a Trial
Pacira Pharms Inc	DEPODUR	morphine sulfate	INJECTABLE, LIPOSOMAL;EPIDURAL	021671-003	May 18, 2004	⤷ Try a Trial	⤷ Try a Trial
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-006	Dec 18, 2008	⤷ Try a Trial	⤷ Try a Trial
>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	1210599	防止濫用的控釋藥物組合物 (ABUSE DETERRENT PHARMACEUTICAL COMPOSITIONS FOR CONTROLLED RELEASE)	⤷ Try a Trial
China	204798475		⤷ Try a Trial
Japan	2010536770		⤷ Try a Trial
Canada	2902343	FORMULATIONS INJECTABLES DE MORPHINE (INJECTABLE MORPHINE FORMULATIONS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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