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Last Updated: January 26, 2020

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Details for New Drug Application (NDA): 022399

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NDA 022399 describes HORIZANT, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the HORIZANT profile page.

The generic ingredient in HORIZANT is gabapentin enacarbil. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gabapentin enacarbil profile page.
Summary for 022399
Applicant:Arbor Pharms Llc
Ingredient:gabapentin enacarbil
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022399
Generic Entry Date for 022399*:
Constraining patent/regulatory exclusivity:

*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: 022399
Suppliers and Packaging for NDA: 022399
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399 NDA Arbor Pharmaceuticals 53451-0101 53451-0101-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)
HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399 NDA Arbor Pharmaceuticals 53451-0101 53451-0101-9 5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-9)
Paragraph IV (Patent) Challenges for 022399
Tradename Dosage Ingredient NDA Submissiondate
HORIZANT TABLET, EXTENDED RELEASE;ORAL gabapentin enacarbil 022399 2019-04-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Apr 6, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 6, 2019
Patent:  Start TrialPatent Expiration:Apr 6, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Nov 10, 2026Product Flag?YSubstance Flag?YDelist Request?

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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.