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Serving leading biopharmaceutical companies globally:

Healthtrust
US Army
McKesson
Citi
US Department of Justice
Boehringer Ingelheim
Julphar
Cantor Fitzgerald
Baxter
Queensland Health

Generated: February 17, 2018

DrugPatentWatch Database Preview

Morphine sulfate - Generic Drug Details

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What are the generic sources for morphine sulfate and what is the scope of morphine sulfate freedom to operate?

Morphine sulfate
is the generic ingredient in twelve branded drugs marketed by King Pharms Llc, Allergan Sales Llc, Actavis Elizabeth, Impax Labs Inc, Par Pharm Inc, Teva Pharms Usa, Upsher-smith Labs, Pacira Pharms Inc, Fresenius Kabi Usa, West-ward Pharms Int, Eurohlth Intl Sarl, Hospira, Hospira Inc, Icu Medical Inc, Meridian Medcl Techn, Specgx Llc, Watson Labs, Hi-tech Pharmacal, Lannett Holdings Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vintage Pharms Llc, Vistapharm, Egalet, 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, Purdue Pharma Lp, Xanodyne Pharms Inc, and Alpharma Pharms, and is included in sixty-six NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate has forty-six patent family members in twelve countries.

There are twenty-three drug master file entries for morphine sulfate. Fifty-three suppliers are listed for this compound.
Summary for morphine sulfate
Pharmacology for morphine sulfate
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for morphine sulfate

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
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-001 Oct 2, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-005 Aug 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Nesher Pharms MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 077855-002 Sep 27, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Xanodyne Pharms Inc ORAMORPH SR morphine sulfate TABLET, EXTENDED RELEASE;ORAL 019977-004 Nov 23, 1994 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 073374-001 Sep 30, 1991 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Egalet ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-002 Jan 9, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-004 Oct 2, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Vistapharm MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 201947-001 Jan 5, 2012 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Rhodes Pharms MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 206420-001 Jul 12, 2016 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Par Pharm Inc MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 200812-004 Nov 10, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 021671-002 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
King Pharms Llc AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260-006 Dec 18, 2008 ➤ Sign Up ➤ Sign Up
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-003 Jul 3, 1996 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-004 Mar 9, 2001 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-004 Mar 9, 2001 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-005 Mar 9, 2001 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-006 Oct 27, 2006 ➤ Sign Up ➤ Sign Up
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for morphine sulfate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,545,473 Packaging system for oxygen-sensitive drugs ➤ Sign Up
2,017,333,354 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for morphine sulfate

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Baxter
Julphar
QuintilesIMS
Farmers Insurance
McKinsey
Merck
Fish and Richardson
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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