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MACRILEN Drug Profile

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When do Macrilen patents expire, and when can generic versions of Macrilen launch?

Macrilen is a drug marketed by Strongbridge Ireland and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-two patent family members in thirty-one countries.

The generic ingredient in MACRILEN is macimorelin acetate. One supplier is listed for this compound. Additional details are available on the macimorelin acetate profile page.

Summary for MACRILEN

International Patents:	72
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Drug Prices:	Drug price information for MACRILEN
DailyMed Link:	MACRILEN at DailyMed

Generic Entry Opportunity Date for MACRILEN

Constraining patent/regulatory exclusivity:

FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)

NDA:

205598

Dosage:

FOR SOLUTION;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.

US Patents and Regulatory Information for MACRILEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strongbridge Ireland	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		RX	Yes	Yes
Strongbridge Ireland	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		RX	Yes	Yes
Strongbridge Ireland	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		RX	Yes	Yes			Y	Y
Strongbridge Ireland	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017		RX	Yes	Yes

International Patents for MACRILEN

Country	Document Number	Estimated Expiration
Poland	216676
Brazil	0111591
South Korea	20030007889
Canada	2407659
Taiwan	I305529