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Last Updated: October 22, 2020

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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, Par Pharm Inc, Teva Pharms Usa, Upsher Smith Labs, Pacira Pharms Inc, Fresenius Kabi Usa, Hikma, Piramal Critical, Hospira, Hospira Inc, Icu Medical Inc, Specgx Llc, Watson Labs, Meridian Medcl Techn, Ani Pharms Inc, Hi Tech, Lannett Co Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Zyla, Daiichi Sankyo Inc, Dava Pharms Inc, Epic Pharma Llc, Mayne Pharma Inc, Mylan Pharms Inc, Nesher Pharms, Novel Labs Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Vintage Pharms Llc, Purdue Pharma Lp, Xanodyne Pharms Inc, and Alpharma Pharms, and is included in sixty-eight 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 twenty-three drug master file entries for morphine sulfate. Thirty-nine suppliers are listed for this compound.

Drug Prices for morphine sulfate

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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

SponsorPhase
Royal Brompton & Harefield NHS Foundation TrustPhase 3
Eric AlbrechtN/A
National Cancer Institute (NCI)Phase 3

See all morphine sulfate clinical trials

Pharmacology for morphine sulfate
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for morphine sulfate
Paragraph IV (Patent) Challenges for MORPHINE SULFATE
Tradename Dosage Ingredient NDA Submissiondate
MORPHABOND ER TABLET, EXTENDED RELEASE;ORAL morphine sulfate 206544 2019-01-28
ARYMO ER TABLET, EXTENDED RELEASE;ORAL morphine sulfate 208603 2017-12-29
AVINZA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate 021260 2009-08-11
AVINZA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate 021260 2009-07-30
AVINZA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate 021260 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
Epic Pharma Llc MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 091357-005 Jun 23, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 200812-005 Nov 10, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009 DISCN Yes No   Start Trial   Start Trial   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-003 Jul 3, 1996   Start Trial   Start Trial
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-002 May 18, 2004   Start Trial   Start Trial
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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