Details for New Drug Application (NDA): 210867

NDA 210867 describes MOXIDECTIN, which is a drug marketed by Mdgh and is included in one NDA. It is available from one supplier. Additional details are available on the MOXIDECTIN profile page.

The generic ingredient in MOXIDECTIN is moxidectin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the moxidectin profile page.

Summary for 210867

Tradename:	MOXIDECTIN
Applicant:	Mdgh
Ingredient:	moxidectin
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210867

Constraining patent/regulatory exclusivity:

TREATMENT OF ONCHOCERCIASIS DUE TO ONCHOCERCA VOLVULUS IN PEDIATRIC PATIENTS AGED 4 TO LESS THAN 12 YEARS AND WEIGHING AT LEAST 13 KG

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: 210867

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOXIDECTIN	moxidectin	TABLET;ORAL	210867	NDA	Medicines Development for Global Health	71705-050	71705-050-01	500 TABLET in 1 BOTTLE, PLASTIC (71705-050-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jun 13, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Feb 7, 2028
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Feb 7, 2032
Regulatory Exclusivity Use:	TREATMENT OF ONCHOCERCIASIS DUE TO ONCHOCERCA VOLVULUS IN PEDIATRIC PATIENTS AGED 4 TO LESS THAN 12 YEARS AND WEIGHING AT LEAST 13 KG

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