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Morphine sulfate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for morphine sulfate?

Morphine sulfate is the generic ingredient in twelve branded drugs marketed by Novel Labs Inc, Egalet, Upsher Smith, Dava Pharms Inc, West-ward Pharms Int, Hospira, Vintage Pharms Llc, Impax Labs Inc, Nostrum Labs Inc, Par Pharm Inc, Mallinckrodt, Hospira Inc, Allergan Sales Llc, Purdue Pharma Lp, Lannett Holdings Inc, Teva Pharms Usa, Tris Pharma Inc, Rhodes Pharms, Nesher Pharms, Fresenius Kabi Usa, Mylan Pharms Inc, Sun Pharm Inds Ltd, Actavis Elizabeth, Daiichi Sankyo Inc, Vistapharm, Mallinckrodt Inc, Watson Labs, Corepharma, Eurohlth Intl Sarl, King Pharms Llc, Pacira Pharms Inc, Pharm Assoc, Paddock Llc, Xanodyne Pharms Inc, Mayne Pharma Inc, Meridian Medcl Techn, and Alpharma Pharms, and is included in sixty-four NDAs. There are twenty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: morphine sulfate

Tradenames:12
Patents:23
Applicants:37
NDAs:64
Drug Master File Entries: see list23
Suppliers / Packagers: see list51
Bulk Api Vendors: see list16
Clinical Trials: see list706
Patent Applications: see list9,862
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:morphine sulfate at DailyMed

Pharmacology for Ingredient: morphine sulfate

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-006Aug 13, 2009RXYesNo7,815,934► SubscribeY ► Subscribe
Upsher Smith
MORPHINE SULFATE
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL202104-003Jun 3, 2013RXNoNo► Subscribe► Subscribe
Nostrum Labs Inc
MORPHINE SULFATE
morphine sulfate
SOLUTION;ORAL201011-002Feb 5, 2014RXNoNo► Subscribe► Subscribe
West-ward Pharms Int
INFUMORPH
morphine sulfate
INJECTABLE;INJECTION018565-004Jul 19, 1991RXYesYes► Subscribe► Subscribe
Xanodyne Pharms Inc
ORAMORPH SR
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL019977-004Nov 23, 1994DISCNNoNo► Subscribe► 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;EPIDURAL021671-003May 18, 20045,997,899► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-002May 18, 20046,171,613► Subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-007Feb 27, 20075,378,474► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-003May 18, 20045,723,147► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-001May 18, 20045,807,572► 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
8,267,452Product gripper► 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
China204798475► Subscribe
Japan2001505224► Subscribe
Australia2009282376► Subscribe
Denmark1023051► Subscribe
World Intellectual Property Organization (WIPO)2010019279► 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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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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