Details for New Drug Application (NDA): 201635
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NDA 201635 describes TROKENDI XR, which is a drug marketed by Supernus Pharms and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TROKENDI XR profile page.
The generic ingredient in TROKENDI XR is topiramate. There are twenty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the topiramate profile page.
The generic ingredient in TROKENDI XR is topiramate. There are twenty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 201635
| Tradename: | TROKENDI XR |
| Applicant: | Supernus Pharms |
| Ingredient: | topiramate |
| Patents: | 10 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201635
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 201635
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TROKENDI XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 201635 | NDA | Supernus Pharmaceuticals | 17772-101 | 17772-101-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-101-01) |
| TROKENDI XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 201635 | NDA | Supernus Pharmaceuticals | 17772-101 | 17772-101-07 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-101-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 16, 2013 | TE: | AB1 | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 16, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 16, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF EPILEPSY | ||||||||
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