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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 212728


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NDA 212728 describes NURTEC ODT, which is a drug marketed by Pfizer 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 NURTEC ODT profile page.

The generic ingredient in NURTEC ODT is rimegepant sulfate. One supplier is listed for this compound. Additional details are available on the rimegepant sulfate profile page.
Summary for 212728
Tradename:NURTEC ODT
Applicant:Pfizer
Ingredient:rimegepant sulfate
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212728
Generic Entry Date for 212728*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, ORALLY DISINTEGRATING;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: 212728
Suppliers and Packaging for NDA: 212728
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NURTEC ODT rimegepant sulfate TABLET, ORALLY DISINTEGRATING;ORAL 212728 NDA Pfizer Laboratories Div Pfizer Inc 72618-3000 72618-3000-2 1 BLISTER PACK in 1 CARTON (72618-3000-2) / 8 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
NURTEC ODT rimegepant sulfate TABLET, ORALLY DISINTEGRATING;ORAL 212728 NDA Pfizer Laboratories Div Pfizer Inc 72618-3001 72618-3001-2 4 DOSE PACK in 1 CARTON (72618-3001-2) / 1 BLISTER PACK in 1 DOSE PACK (72618-3001-1) / 2 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 75MG BASE
Approval Date:Feb 27, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:May 27, 2024
Regulatory Exclusivity Use:FOR THE PREVENTIVE TREATMENT OF EPISODIC MIGRAINE IN ADULTS
Regulatory Exclusivity Expiration:Feb 27, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  SubscribePatent Expiration:Mar 25, 2039Product Flag?YSubstance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS

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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 verification 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.