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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 six 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-eight suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for NDA: 201635

Tradename:
TROKENDI XR
Applicant:
Supernus Pharms
Ingredient:
topiramate
Patents:6
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, Inc. 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, Inc. 17772-101 17772-101-15 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-101-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Aug 16, 2013TE:RLD:No
Patent:8,298,576Patent Expiration:Apr 4, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF EPILEPSY
Patent:8,298,580Patent Expiration:Nov 16, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF EPILEPSY
Patent:8,663,683Patent Expiration:Nov 16, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF EPILEPSY


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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