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Last Updated: May 24, 2022

MACRILEN Drug Patent Profile


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

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

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

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

DrugPatentWatch® Generic Entry Outlook for Macrilen

Macrilen was eligible for patent challenges on December 20, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 20, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MACRILEN
International Patents:73
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 10
Clinical Trials: 2
Patent Applications: 46
Drug Prices: Drug price information for MACRILEN
What excipients (inactive ingredients) are in MACRILEN?MACRILEN excipients list
DailyMed Link:MACRILEN at DailyMed
Drug patent expirations by year for MACRILEN
Drug Prices for MACRILEN

See drug prices for MACRILEN

DrugPatentWatch® Estimated Generic Entry Opportunity Date for MACRILEN
Generic Entry Date for MACRILEN*:
Constraining patent/regulatory exclusivity:
FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)
NDA:
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.

Recent Clinical Trials for MACRILEN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
VA Office of Research and DevelopmentPhase 3
Novo Nordisk A/SPhase 3
AEterna ZentarisPhase 3

See all MACRILEN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MACRILEN

US Patents and Regulatory Information for MACRILEN

MACRILEN is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MACRILEN is See Plans and Pricing.

This potential generic entry date is based on FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MACRILEN

Growth hormone secretagogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN

Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN

FDA Regulatory Exclusivity protecting MACRILEN

FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

International Patents for MACRILEN

See the table below for patents covering MACRILEN around the world.

Country Patent Number Title Estimated Expiration
Hungary 229233 Growth hormone secretagogues See Plans and Pricing
Cyprus 1107793 See Plans and Pricing
Czech Republic 303173 Deriváty indolu zvyšující sekreci rustového hormonu (Indole derivatives increasing growth hormone secretion) See Plans and Pricing
Japan 3522265 See Plans and Pricing
Bulgaria 110708 See Plans and Pricing
Russian Federation 2270198 СРЕДСТВА, УСИЛИВАЮЩИЕ СЕКРЕЦИЮ ГОРМОНА РОСТА (AGENTS ENHANCING GROWTH HORMONE SECRETION) See Plans and Pricing
Hong Kong 1054224 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MACRILEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1289951 122019000074 Germany See Plans and Pricing PRODUCT NAME: MACIMORELIN, OPTIONAL IN FORM EINER ARZNEIMITTELZUSAMMENSETZUNG, OPTIONAL IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE MACIMORELIN ACETAT.; REGISTRATION NO/DATE: EU/1/18/1337 20190111
1289951 132019000000099 Italy See Plans and Pricing PRODUCT NAME: MACIMORELINA, OPZIONALMENTE NELLA FORMA DI UNA COMPOSIZIONE FARMACEUTICA, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, COMPRESA MACIMORELINA ACETATO(MACIMORELIN AETERNA ZENTARIS - MACIMORELINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1337, 20190115
1289951 CA 2019 00037 Denmark See Plans and Pricing PRODUCT NAME: MACIMORELIN, EN FARMACEUTISK SAMMENSAETNING DERAF ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1337 20190115
1289951 C201930046 Spain See Plans and Pricing PRODUCT NAME: MACIMORELINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1337; DATE OF AUTHORISATION: 20190111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1337; DATE OF FIRST AUTHORISATION IN EEA: 20190111
1289951 300999 Netherlands See Plans and Pricing PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
McKinsey
Express Scripts
AstraZeneca
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.