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Details for New Drug Application (NDA): 207145
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NDA 207145 describes XADAGO, which is a drug marketed by Us Worldmeds Llc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the XADAGO profile page.
The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.
The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.
Summary for 207145
| Tradename: | XADAGO |
| Applicant: | Us Worldmeds Llc |
| Ingredient: | safinamide mesylate |
| Patents: | 3 |
Generic Entry Opportunity Date for 207145
Generic Entry Date for 207145*:
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: 207145
| Mechanism of Action | Monoamine Oxidase-B Inhibitors Breast Cancer Resistance Protein Inhibitors |
Suppliers and Packaging for NDA: 207145
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XADAGO | safinamide mesylate | TABLET;ORAL | 207145 | NDA | US WorldMeds, LLC | 27505-110 | 27505-110-14 | 1 BLISTER PACK in 1 CARTON (27505-110-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK |
| XADAGO | safinamide mesylate | TABLET;ORAL | 207145 | NDA | US WorldMeds, LLC | 27505-110 | 27505-110-30 | 1 BOTTLE in 1 CARTON (27505-110-30) > 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Mar 21, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 21, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Dec 10, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jun 8, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES | ||||||||
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