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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
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Chinese Patent Office
Deloitte
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Generated: November 23, 2017

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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 morphine sulfate freedom to operate?

Morphine sulfate
is the generic ingredient in twelve branded drugs marketed by Novel Labs Inc, Egalet, Upsher-smith Labs, Dava Pharms Inc, West-ward Pharms Int, Rhodes Pharms, Hospira, Hi-tech Pharmacal, Vintage Pharms Llc, Impax Labs Inc, Nostrum Labs Inc, Par Pharm Inc, Mallinckrodt, Hospira Inc, Allergan Sales Llc, Icu Medical Inc, Purdue Pharma Lp, Lannett Holdings Inc, Teva Pharms Usa, Tris Pharma Inc, Nesher Pharms, Fresenius Kabi Usa, Mylan Pharms Inc, Mallinckrodt Inc, Sun Pharm Inds, Actavis Elizabeth, Daiichi Sankyo Inc, Vistapharm, Watson Labs, Epic Pharma Llc, Eurohlth Intl Sarl, King Pharms Llc, Sun Pharm Inds Ltd, Pacira Pharms Inc, Pharm Assoc, Paddock Llc, Xanodyne Pharms Inc, Mayne Pharma Inc, Meridian Medcl Techn, 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-five patent family members in twenty-one countries.

There are twenty-three drug master file entries for morphine sulfate. Fifty-three suppliers are listed for this compound.

Pharmacology for morphine sulfate

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories 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
Nesher Pharms
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL076720-002Dec 23, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-002Aug 13, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-004Aug 13, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
MORPHINE SULFATE
morphine sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-001Oct 30, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Teva Pharms Usa
MORPHINE SULFATE
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL202718-008Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
MORPHINE SULFATE
morphine sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-005Oct 30, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Watson Labs
MORPHINE SULFATE
morphine sulfate
INJECTABLE;INJECTION073373-001Sep 30, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe
Epic Pharma Llc
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL091357-003Jun 23, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Xanodyne Pharms Inc
ORAMORPH SR
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL019977-003Aug 15, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe
Egalet
ARYMO ER
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL208603-003Jan 9, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: morphine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-002May 18, 2004► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-003May 18, 2004► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-002May 18, 2004► Subscribe► Subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-007Feb 27, 2007► Subscribe► Subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-003Jul 3, 1996► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-003May 18, 2004► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-002May 18, 2004► Subscribe► Subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-006Oct 27, 2006► Subscribe► Subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-008Apr 20, 2007► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-001May 18, 2004► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,545,473Packaging system for oxygen-sensitive drugs► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: morphine sulfate

Country Document Number Estimated Expiration
Germany69721845► Subscribe
World Intellectual Property Organization (WIPO)9814171► Subscribe
Canada2734075► Subscribe
European Patent Office2968729► Subscribe
Denmark0971699► Subscribe
World Intellectual Property Organization (WIPO)2009023672► Subscribe
Japan2001505549► Subscribe
New Zealand334837► Subscribe
South Korea20150059167► Subscribe
Australia2013285988► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Healthtrust
Queensland Health
Merck
Cerilliant
UBS
Citi
Federal Trade Commission
Harvard Business School
Julphar
Covington

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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