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MORPHINE SULFATE - Generic Drug Details

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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-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety patent family members in twenty countries.

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

Summary for Generic Name: MORPHINE SULFATE

Tradenames:12
Patents:21
Applicants:37
NDAs:64
Drug Master File Entries: see list23
Suppliers / Packagers: see list49
Bulk Api Vendors: see list16
Clinical Trials: see list706
Patent Applications: see list9,796
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;ORAL022321-004Aug 13, 2009RXYesYes8,685,443► subscribe ► subscribe
Par Pharm Inc
MORPHINE SULFATE
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL200812-002Nov 10, 2011RXNoNo► subscribe► subscribe
Nesher Pharms
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL077855-002Sep 27, 2007RXNoNo► 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;EPIDURAL021671-002May 18, 20046,171,613► subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-002May 18, 20046,241,999► subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-003May 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
8,267,452Product gripper► subscribe
9,549,899Abuse deterrent pharmaceutical compositions for controlled release► 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
World Intellectual Property Organization (WIPO)9814171► subscribe
China105534936► subscribe
Hong Kong1210599► 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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