Details for New Drug Application (NDA): 204760
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NDA 204760 describes MOVANTIK, which is a drug marketed by Valinor and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MOVANTIK profile page.
The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxegol oxalate profile page.
The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxegol oxalate profile page.
Summary for 204760
| Tradename: | MOVANTIK |
| Applicant: | Valinor |
| Ingredient: | naloxegol oxalate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204760
Generic Entry Date for 204760*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 204760
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 204760
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760 | NDA | Quality Care Products, LLC | 55700-988 | 55700-988-30 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-988-30) |
| MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760 | NDA | RedHill Biopharma Ltd | 57841-1300 | 57841-1300-1 | 30 TABLET, FILM COATED in 1 BOTTLE (57841-1300-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 12.5MG BASE | ||||
| Approval Date: | Sep 16, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jun 29, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF OPIOID-INDUCED CONSTIPATION | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Sep 16, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 16, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF OPIOID-INDUCED CONSTIPATION | ||||||||
Expired US Patents for NDA 204760
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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