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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 Redhill and is included in one NDA. There are six 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 twelve patent family members in forty-one countries.
There are three drug master file entries for naloxegol oxalate. Three suppliers are listed for this compound.
Summary for naloxegol oxalate
International Patents: | 112 |
US Patents: | 6 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 3 |
Suppliers / Packagers: | 3 |
Bulk Api Vendors: | 22 |
Clinical Trials: | 1 |
Patent Applications: | 1 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for naloxegol oxalate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Institut Paoli-Calmettes | Phase 2 |
Pharmacology for naloxegol oxalate
Drug Class | Opioid Antagonist |
Mechanism of Action | Opioid Antagonists |
Paragraph IV (Patent) Challenges for NALOXEGOL OXALATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MOVANTIK | TABLET;ORAL | naloxegol oxalate | 204760 | 2018-09-17 |
US Patents and Regulatory Information for naloxegol oxalate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Redhill | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for naloxegol oxalate
Country | Patent Number | Estimated Expiration |
---|---|---|
Croatia | P20140361 | Start Trial |
Montenegro | 02313 | Start Trial |
Eurasian Patent Organization | 201300423 | Start Trial |
Cyprus | 1119906 | Start Trial |
Serbia | 53279 | Start Trial |
Denmark | 2621496 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for naloxegol oxalate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1694363 | 27/2015 | Austria | Start Trial | PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
1694363 | PA2015019,C1694363 | Lithuania | Start Trial | PRODUCT NAME: NALOKSEGOLAS, KONKRECIAI NALOKSEGOLO OKSALATO DRUSKA; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
1694363 | C300737 | Netherlands | Start Trial | PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
1694363 | 592 | Finland | Start Trial | |
1694363 | 15C0037 | France | Start Trial | 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 | 2015/024 | Ireland | Start Trial | PRODUCT NAME: NALOXEGOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE OXALATE SALT OF THE ALPHA-EPIMER OF NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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