Details for New Drug Application (NDA): 204760
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NDA 204760 describes MOVANTIK, which is a drug marketed by Averitas and is included in one NDA. It is available from two suppliers. There are two 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. Two 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. Two suppliers are listed for this compound. Additional details are available on the naloxegol oxalate profile page.
Summary for 204760
| Tradename: | MOVANTIK |
| Applicant: | Averitas |
| Ingredient: | naloxegol oxalate |
| Patents: | 2 |
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 | RedHill Biopharma Ltd | 57841-1301 | 57841-1301-1 | 30 TABLET, FILM COATED in 1 BOTTLE (57841-1301-1) |
| MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760 | NDA | RedHill Biopharma Ltd | 57841-1301 | 57841-1301-2 | 90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2) |
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: | ⤷ Start Trial | Patent Expiration: | Sep 16, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 2, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Sep 16, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 16, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 204760
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Averitas | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Averitas | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Averitas | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| Averitas | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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