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Serving leading biopharmaceutical companies globally:

Healthtrust
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Generated: January 21, 2018

DrugPatentWatch Database Preview

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 nine 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-three 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:9
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Formulation / Manufacturing:see details
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 17772-101-15 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-101-15)
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Aug 16, 2013TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Apr 4, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:➤ SubscribePatent Expiration:Apr 4, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF EPILEPSY
Patent:➤ SubscribePatent Expiration:Nov 16, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Merck
Accenture
Johnson and Johnson
Healthtrust
Queensland Health
Medtronic
Farmers Insurance
Colorcon
McKinsey

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