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Last Updated: July 23, 2021

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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 freedom to operate?

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, Intl Medication Sys, Specgx Llc, Watson Labs, Meridian Medcl Techn, Akorn, Ani Pharms, Lannett Co Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, 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, Alkem Labs Ltd, and Alpharma Pharms, and is included in seventy-two 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. Eighteen suppliers are listed for this compound. There is one tentative approval 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
Chiang Mai UniversityPhase 4
University of UtahPhase 2
Seoul National University HospitalN/A

See all morphine sulfate clinical trials

Generic filers with tentative approvals for MORPHINE SULFATE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free30MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free15MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-001 Aug 13, 2009 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Mayne Pharma Inc MORPHINE SULFATE morphine sulfate TABLET;ORAL 207270-002 Jun 2, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Tris Pharma Inc MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 203519-001 May 18, 2016 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Purdue Pharma Lp MS CONTIN morphine sulfate TABLET, EXTENDED RELEASE;ORAL 019516-002 Apr 8, 1988 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Xanodyne Pharms Inc ORAMORPH SR morphine sulfate TABLET, EXTENDED RELEASE;ORAL 019977-003 Aug 15, 1991 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Pharms Inc MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 200824-004 Oct 18, 2011 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hikma MORPHINE SULFATE morphine sulfate TABLET;ORAL 022207-001 Mar 17, 2008 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
Purdue Pharma Lp MS CONTIN morphine sulfate TABLET, EXTENDED RELEASE;ORAL 019516-003 Sep 12, 1989 ⤷  Try it Free ⤷  Try it Free
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-003 May 18, 2004 ⤷  Try it Free ⤷  Try it Free
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-004 Mar 9, 2001 ⤷  Try it Free ⤷  Try it Free
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-002 May 18, 2004 ⤷  Try it Free ⤷  Try it Free
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-003 Jul 3, 1996 ⤷  Try it Free ⤷  Try it Free
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-002 May 18, 2004 ⤷  Try it Free ⤷  Try it Free
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
Express Scripts
McKesson
Baxter
Mallinckrodt

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