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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Teva
Merck
UBS
Dow
Julphar
Colorcon
Accenture
AstraZeneca
Daiichi Sankyo

Generated: December 16, 2017

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Naloxegol oxalate - Generic Drug Details

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What are the generic sources for naloxegol oxalate and what is the scope of naloxegol oxalate freedom to operate?

Naloxegol oxalate
is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naloxegol oxalate has ninety-nine patent family members in thirty-seven countries and thirteen supplementary protection certificates in ten countries.

Three suppliers are listed for this compound.

Summary for naloxegol oxalate

Pharmacology for naloxegol oxalate

Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-002Sep 16, 2014RXYesYes► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-002Sep 16, 2014RXYesYes► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-001Sep 16, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-001Sep 16, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-002Sep 16, 2014RXYesYes► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-001Sep 16, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-001Sep 16, 2014RXYesNo► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-002Sep 16, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-001Sep 16, 2014RXYesNo► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsMOVANTIKnaloxegol oxalateTABLET;ORAL204760-001Sep 16, 2014RXYesNo► Subscribe► SubscribeYY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: naloxegol oxalate

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
2,015,197,470► Subscribe
9,149,539Crystalline naloxol-PEG conjugate► Subscribe
8,349,307Polymer conjugates of opioid antagonists► Subscribe
9,388,104Chemically modified small molecules► Subscribe
8,034,825Chemically modified small molecules► 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: naloxegol oxalate

Country Document Number Estimated Expiration
San MarinoT201600004► Subscribe
CroatiaP20151420► Subscribe
Hong Kong1215171► Subscribe
European Patent Office2939696► Subscribe
South Korea20090130155► Subscribe
Japan2005506351► Subscribe
Serbia54488► Subscribe
Spain2569262► Subscribe
Japan4814488► Subscribe
Eurasian Patent Organization201000994► 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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Supplementary Protection Certificates for Tradename: NALOXEGOL OXALATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0737Netherlands► SubscribePRODUCT NAME: NALOXEGOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NALOGEXOLOXALAAT; REGISTRATION NO/DATE: EU/1/14/962 20141210
2015 00028Denmark► SubscribePRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
702Luxembourg► SubscribePRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210
/2015Austria► SubscribePRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208
C0037France► SubscribePRODUCT NAME: NALOXEGOL OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER L'OXALATE DE NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141210
90027-7Sweden► SubscribePRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
00737Netherlands► SubscribePRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208
4 5008-2015Slovakia► SubscribePRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210
2015 00028Denmark► SubscribePRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141208
2015000037Germany► SubscribePRODUCT NAME: NALOXEGOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/962 20141208
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Serving leading biopharmaceutical companies globally:

Queensland Health
Medtronic
Moodys
QuintilesIMS
Julphar
McKinsey
Farmers Insurance
Johnson and Johnson
Harvard Business School
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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