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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210166


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NDA 210166 describes MOTEGRITY, which is a drug marketed by Shire Dev Llc and is included in one NDA. It is available from one supplier. Additional details are available on the MOTEGRITY profile page.

The generic ingredient in MOTEGRITY is prucalopride succinate. One supplier is listed for this compound. Additional details are available on the prucalopride succinate profile page.
Summary for 210166
Tradename:MOTEGRITY
Applicant:Shire Dev Llc
Ingredient:prucalopride succinate
Patents:0
Generic Entry Opportunity Date for 210166
Generic Entry Date for 210166*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
TABLET;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.

Suppliers and Packaging for NDA: 210166
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOTEGRITY prucalopride succinate TABLET;ORAL 210166 NDA Shire US Manufacturing Inc. 54092-546 54092-546-01 30 TABLET, FILM COATED in 1 BOTTLE (54092-546-01)
MOTEGRITY prucalopride succinate TABLET;ORAL 210166 NDA Shire US Manufacturing Inc. 54092-547 54092-547-01 30 TABLET, FILM COATED in 1 BOTTLE (54092-547-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Dec 14, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 14, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Dec 14, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 14, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving leading biopharmaceutical companies globally:

Colorcon
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AstraZeneca

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