Naloxegol oxalate - Generic Drug Details

✉ Email this page to a colleague

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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	204760-002	Sep 16, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	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
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	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	204760-001	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				⤷ 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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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	204760-002	Sep 16, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for naloxegol oxalate

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Brazil	112013007113	conjugado de naloxol-peg cristalino	⤷ Sign Up
South Korea	101791724		⤷ Sign Up
Portugal	2621496		⤷ Sign Up
South Korea	101168620		⤷ Sign Up
Canada	2758460	PETITES MOLECULES CHIMIQUEMENT MODIFIEES (CHEMICALLY MODIFIED SMALL MOLECULES)	⤷ Sign Up
South Africa	200605763	Pegylated small molecules	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for naloxegol oxalate

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	15C0037	France	⤷ Sign Up	PRODUCT NAME: NALOXEGOL OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER L'OXALATE DE NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363	CR 2015 00028	Denmark	⤷ Sign Up	PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
1694363	27/2015	Austria	⤷ Sign Up	PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	300737	Netherlands	⤷ Sign Up	PRODUCT NAME: NALOXEGOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NALOGEXOLOXALAAT; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363	C300737	Netherlands	⤷ Sign Up	PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	CA 2015 00028	Denmark	⤷ Sign Up	PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141208
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.