Is there a generic for Macimorelin acetate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Macimorelin acetate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Macimorelin acetate?

MACRILEN (NDA 205598, AETERNA ZENTARIS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Macimorelin acetate?

The Orange Book lists 2 patents against Macimorelin acetate products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Macimorelin acetate have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Macimorelin acetate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Macimorelin acetate are approved?

Macimorelin acetate is approved in the following dosage form: for solution.

FDA Orange Book · active-ingredient family

Macimorelin acetate

Macimorelin acetate: 1 brand, 0 generics; first approved Dec 20, 2017; on patent until Oct 12, 2027.

On patent2 exclusivity periodsHas discontinued products

Generic status & protection

Protected until Oct 12, 2027 (earliest listed patent expiry).

Earliest patent expiry Oct 12, 2027Latest exclusivity ends Jan 23, 2030

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 12, 2027

in 11 mo

Brand (NDA) products

Originator applications

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MACRILENRLD
AETERNA ZENTARISNDA 2055982017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 60MG BASE/POUCH FOR SOLUTION ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 60MG BASE/POUCH	FOR SOLUTION	ORAL	Discontinued	-

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

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M-14New use / labeling-change exclusivity (3 years)
Jul 23, 2029
in 2 yr 9 mo
PEDPediatric exclusivity (adds 6 months)
Jan 23, 2030
in 3 yr 3 mo

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8192719	Oct 12, 2027	in 11 mo	U-2220
8192719*PED	Apr 12, 2028	in 1 yr 6 mo

Approval history

FDA approval span

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First approval

Dec 20, 2017

9 yr ago

Most recent approval

Dec 20, 2017

9 yr ago

All 1 application were approved in 2017.

Brand (NDA) 1100%

Generic (ANDA) 00%

Macimorelin acetate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

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