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Serving leading biopharmaceutical companies globally:

Chubb
Harvard Business School
Daiichi Sankyo
Dow
Merck
Queensland Health
Mallinckrodt
UBS
Chinese Patent Office
Deloitte

Generated: January 18, 2018

DrugPatentWatch Database Preview

MORPHINE SULFATE - Generic Drug Details

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

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, Mallinckrodt Inc, Meridian Medcl Techn, 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, Mallinckrodt, 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 twenty-two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate has ninety-six patent family members in twenty-one countries.

There are twenty-three drug master file entries for morphine sulfate. Fifty-four 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
Hi-tech Pharmacal MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 208809-001 Jul 6, 2017 AA RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa ASTRAMORPH PF morphine sulfate INJECTABLE;INJECTION 071053-001 Oct 7, 1986 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-001 Oct 30, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Egalet ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-002 Jan 9, 2017 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-004 Aug 13, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 200824-002 Oct 18, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-002 Oct 30, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Par Pharm Inc MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 200812-004 Nov 10, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sun Pharm Industries MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 205634-004 Aug 25, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 021671-003 May 18, 2004 ➤ Subscribe ➤ Subscribe
Purdue Pharma Lp MS CONTIN morphine sulfate TABLET, EXTENDED RELEASE;ORAL 019516-001 May 29, 1987 ➤ Subscribe ➤ Subscribe
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-003 May 18, 2004 ➤ Subscribe ➤ Subscribe
King Pharms Llc AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260-003 Mar 20, 2002 ➤ Subscribe ➤ Subscribe
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-004 Mar 9, 2001 ➤ Subscribe ➤ Subscribe
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-003 Jul 3, 1996 ➤ Subscribe ➤ Subscribe
King Pharms Llc AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260-001 Mar 20, 2002 ➤ Subscribe ➤ Subscribe
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-007 Feb 27, 2007 ➤ Subscribe ➤ Subscribe
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-003 May 18, 2004 ➤ Subscribe ➤ Subscribe
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-003 Jul 3, 1996 ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe
2,017,333,354 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for MORPHINE SULFATE

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Serving leading biopharmaceutical companies globally:

Covington
Medtronic
Federal Trade Commission
Chinese Patent Office
McKinsey
Teva
US Department of Justice
Harvard Business School
Chubb

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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