NALOXEGOL OXALATE - Generic Drug Details

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What are the generic drug sources for naloxegol oxalate and what is the scope of patent protection?

Naloxegol oxalate is the generic ingredient in one branded drug marketed by Valinor and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxegol oxalate has one hundred and sixteen patent family members in forty-four countries.

There are three drug master file entries for naloxegol oxalate. Three suppliers are listed for this compound.

Summary for NALOXEGOL OXALATE

International Patents:	116
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	1
Patent Applications:	29
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NALOXEGOL OXALATE
What excipients (inactive ingredients) are in NALOXEGOL OXALATE?	NALOXEGOL OXALATE excipients list
DailyMed Link:	NALOXEGOL OXALATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NALOXEGOL OXALATE

Generic Entry Date for NALOXEGOL OXALATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NALOXEGOL OXALATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Institut Paoli-Calmettes	Phase 2

See all NALOXEGOL OXALATE clinical trials

Pharmacology for NALOXEGOL OXALATE

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NALOXEGOL OXALATE

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for NALOXEGOL OXALATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOVANTIK	Tablets	naloxegol oxalate	12.5 mg and 25 mg	204760	2	2018-09-17

US Patents and Regulatory Information for NALOXEGOL OXALATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for NALOXEGOL OXALATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014	⤷ Sign Up	⤷ Sign Up
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014	⤷ Sign Up	⤷ Sign Up
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014	⤷ Sign Up	⤷ Sign Up
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014	⤷ Sign Up	⤷ Sign Up
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for NALOXEGOL OXALATE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2236161		⤷ Sign Up
Denmark	1694363		⤷ Sign Up
Costa Rica	20130146	CONJUGADO DE NALOXOL-PEG CRISTALINO	⤷ Sign Up
San Marino	T201600004	CONIUGATO CRISTALLINO DI NALOXOLO-PEG	⤷ Sign Up
Eurasian Patent Organization	018427	ХИМИЧЕСКИ МОДИФИЦИРОВАННЫЙ НАЛОКСОН (CHEMICALLY MODIFIED NALOXONE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NALOXEGOL OXALATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	234 5008-2015	Slovakia	⤷ Sign Up	PRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363	SPC/GB15/026	United Kingdom	⤷ Sign Up	PRODUCT NAME: NALOXEGOL OXALATE; REGISTERED: UK EU/1/14/962/001-011 20141210
1694363	PA2015019,C1694363	Lithuania	⤷ Sign Up	PRODUCT NAME: NALOKSEGOLAS, KONKRECIAI NALOKSEGOLO OKSALATO DRUSKA; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	C20150020 00290	Estonia	⤷ Sign Up	PRODUCT NAME: NALOKSEGOOL;REG NO/DATE: EU/1/14/962 10.12.2014
1694363	122015000037	Germany	⤷ Sign Up	PRODUCT NAME: NALOXEGOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/962 20141208
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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