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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Chinese Patent Office
Harvard Business School
Daiichi Sankyo
Covington
Julphar
Cipla
Chubb
Dow

Generated: December 16, 2017

DrugPatentWatch Database Preview

MORPHINE SULFATE Drug Profile

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Which patents cover Morphine Sulfate, and what generic alternatives are available?

Morphine Sulfate is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Par Pharm Inc, Teva Pharms Usa, Upsher-smith Labs, Eurohlth Intl Sarl, Hospira, Hospira Inc, Icu Medical Inc, Mallinckrodt Inc, Meridian Medcl Techn, Watson Labs, Fresenius Kabi Usa, Hi-tech Pharmacal, Lannett Holdings Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vintage Pharms Llc, Vistapharm, West-ward Pharms Int, Dava Pharms Inc, Epic Pharma Llc, Mallinckrodt, Mayne Pharma Inc, Mylan Pharms Inc, Nesher Pharms, Novel Labs Inc, Sun Pharm Inds Ltd, and Sun Pharm Industries. and is included in fifty-three NDAs. There are three patents protecting this drug.

This drug has fifteen patent family members in seven countries.

The generic ingredient in MORPHINE SULFATE is morphine sulfate. There are twenty-three drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Drug patent expirations by year 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi UsaMORPHINE SULFATEmorphine sulfateSOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-005Oct 30, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Actavis ElizabethMORPHINE SULFATEmorphine sulfateTABLET, EXTENDED RELEASE;ORAL203849-005Apr 6, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Hospira IncMORPHINE SULFATEmorphine sulfateINJECTABLE;INJECTION202515-001Nov 14, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Upsher-smith LabsMORPHINE SULFATEmorphine sulfateCAPSULE, EXTENDED RELEASE;ORAL202104-006Jun 3, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Rhodes PharmsMORPHINE SULFATEmorphine sulfateSOLUTION;ORAL206308-002Jun 22, 2017AARXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma IncMORPHINE SULFATEmorphine sulfateTABLET, EXTENDED RELEASE;ORAL205386-002Oct 28, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds LtdMORPHINE SULFATEmorphine sulfateTABLET, EXTENDED RELEASE;ORAL078761-005May 11, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt IncMORPHINE SULFATEmorphine sulfateINJECTABLE;INJECTION020631-001Jul 3, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
MallinckrodtMORPHINE SULFATEmorphine sulfateTABLET, EXTENDED RELEASE;ORAL076438-001Jul 3, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaMORPHINE SULFATEmorphine sulfateSOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-002Oct 30, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Tradename: 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 Tradename: MORPHINE SULFATE

Country Document Number Estimated Expiration
European Patent Office3143988► Subscribe
Japan2016512210► Subscribe
European Patent Office2968132► Subscribe
World Intellectual Property Organization (WIPO)2014140095► Subscribe
China104042565► Subscribe
Japan2016512455► Subscribe
Canada2902346► Subscribe
Australia2014230836► Subscribe
Australia2014230834► Subscribe
China204798475► 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:

UBS
Colorcon
Accenture
Baxter
US Army
Deloitte
Teva
Merck
Novartis
Cerilliant

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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