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Last Updated: May 12, 2021

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Details for New Drug Application (NDA): 210875

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NDA 210875 describes KYNMOBI, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug. Additional details are available on the KYNMOBI profile page.

The generic ingredient in KYNMOBI is apomorphine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apomorphine hydrochloride profile page.
Summary for 210875
Applicant:Sunovion Pharms Inc
Ingredient:apomorphine hydrochloride
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 210875
Generic Entry Date for 210875*:
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: 210875
Mechanism of ActionDopamine Agonists
Medical Subject Heading (MeSH) Categories for 210875
Suppliers and Packaging for NDA: 210875
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KYNMOBI apomorphine hydrochloride FILM;SUBLINGUAL 210875 NDA Sunovion Pharmaceuticals Inc. 63402-010 63402-010-30 30 POUCH in 1 CARTON (63402-010-30) > 1 FILM, SOLUBLE in 1 POUCH (63402-010-01)
KYNMOBI apomorphine hydrochloride FILM;SUBLINGUAL 210875 NDA Sunovion Pharmaceuticals Inc. 63402-015 63402-015-30 30 POUCH in 1 CARTON (63402-015-30) > 1 FILM, SOLUBLE in 1 POUCH (63402-015-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;SUBLINGUALStrength10MG
Approval Date:May 21, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:May 21, 2023
Regulatory Exclusivity Use:
Patent:  Get Started for $10Patent Expiration:Jun 11, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:  Get Started for $10Patent Expiration:Apr 19, 2036Product Flag?Substance Flag?Delist Request?

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