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Generated: September 22, 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-four patent family members in twenty countries.

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

Summary for Generic Name: morphine sulfate

Tradenames:12
Patents:22
Applicants:40
NDAs:66
Drug Master File Entries: see list23
Suppliers / Packagers: see list54
Bulk Api Vendors: see list16
Clinical Trials: see list1,706
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira Inc
MORPHINE SULFATE
morphine sulfate
INJECTABLE;INJECTION202515-005Nov 14, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
Vintage Pharms Llc
MORPHINE SULFATE
morphine sulfate
SOLUTION;ORAL202309-001Nov 25, 2015AARXNoNo► Subscribe► Subscribe► Subscribe
Egalet
ARYMO ER
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL208603-001Jan 9, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-006Aug 13, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-005Aug 13, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
MORPHINE SULFATE
morphine sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-004Oct 30, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-005Aug 13, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
ASTRAMORPH PF
morphine sulfate
INJECTABLE;INJECTION071051-001Oct 7, 1986APRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
MORPHINE SULFATE
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL200411-004Apr 12, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Vintage Pharms Llc
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL075295-002Oct 28, 1998ABRXNoNo► Subscribe► 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
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-006Oct 27, 2006► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-003May 18, 2004► Subscribe► Subscribe
Purdue Pharma Lp
MS CONTIN
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL019516-001May 29, 1987► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-003May 18, 2004► Subscribe► Subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-006Oct 27, 2006► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-001May 18, 2004► Subscribe► Subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-007Feb 27, 2007► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-003May 18, 2004► Subscribe► Subscribe
Pacira Pharms Inc
DEPODUR
morphine sulfate
INJECTABLE, LIPOSOMAL;EPIDURAL021671-001May 18, 2004► Subscribe► Subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-008Apr 20, 2007► 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
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
Norway993635► Subscribe
Israel129145► Subscribe
World Intellectual Property Organization (WIPO)2010019279► Subscribe
Norway20100437► Subscribe
Japan2001505224► Subscribe
Australia2013285988► Subscribe
European Patent Office1023051► Subscribe
Japan2015521988► Subscribe
European Patent Office2322143► Subscribe
Japan3473959► 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 500+ biopharmaceutical companies globally:

Medtronic
Chubb
Boehringer Ingelheim
Moodys
Cerilliant
Cantor Fitzgerald
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Baxter
Merck
Accenture

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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