MACRILEN Drug Patent Profile

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 is one patent protecting this drug.

This drug has eleven patent family members in ten 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.

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 October 12, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MACRILEN

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	34
Drug Prices:	Drug price information for MACRILEN
What excipients (inactive ingredients) are in MACRILEN?	MACRILEN excipients list
DailyMed Link:	MACRILEN at DailyMed

See drug prices for MACRILEN

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

Constraining patent/regulatory exclusivity:

8,192,719

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.

Recent Clinical Trials for MACRILEN

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

Sponsor	Phase
VA Office of Research and Development	Phase 3
AEterna Zentaris	Phase 3
Novo Nordisk A/S	Phase 3

See all MACRILEN clinical trials

Pharmacology for MACRILEN

Drug Class	Growth Hormone Secretagogue Receptor Agonist
Mechanism of Action	Growth Hormone Secretagogue Receptor Agonists

US Patents and Regulatory Information for MACRILEN

MACRILEN is protected by one US patents.

This potential generic entry date is based on patent 8,192,719.

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

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		DISCN	Yes	No	8,192,719

Expired US Patents for MACRILEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598-001	Dec 20, 2017	6,861,409

International Patents for MACRILEN

When does loss-of-exclusivity occur for MACRILEN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Denmark

European Patent Office

Japan

Poland

Portugal

Slovenia

Spain

United Kingdom

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

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

Country	Patent Number	Title	Estimated Expiration
China	1736985
Hong Kong	1056555
South Korea	100825109

Supplementary Protection Certificates for MACRILEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1289951	122019000074	Germany		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		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		PRODUCT NAME: MACIMORELIN, EN FARMACEUTISK SAMMENSAETNING DERAF ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1337 20190115

Market Dynamics and Financial Trajectory for Macrilen (Macimorelin)

Introduction

Macrilen, also known as macimorelin, is a diagnostic drug developed by Aeterna Zentaris Inc. for the diagnosis of adult growth hormone deficiency (AGHD) and potentially for childhood onset growth hormone deficiency (CGHD). Here, we will delve into the market dynamics and financial trajectory of Macrilen, highlighting key developments, challenges, and future prospects.

Market Background

Macrilen is part of a niche market focused on growth hormone deficiency diagnostics. The drug has been marketed under different brand names in various regions, such as Macrilen in North America and GHRYVELIN in the UK and European Economic Area (EEA)[4].

Commercialization and Partnerships

Initial Commercialization

Macrilen was initially commercialized in North America through a license agreement with Novo Nordisk Healthcare AG. However, Novo Nordisk decided to end this agreement in August 2022, leading to a temporary discontinuation of Macrilen sales in the U.S. effective May 23, 2023[1][4].

Current Status and New Partnerships

Aeterna Zentaris is actively seeking new development and commercialization partners for Macrilen in the U.S. and Canada. In the meantime, sales and commercialization efforts continue uninterrupted in the UK and EEA, where Pharmanovia has acquired the exclusive rights to commercialize GHRYVELIN[4].

Financial Impact

Revenue Disruption

The temporary discontinuation of Macrilen sales in the U.S. has significant financial implications for Aeterna Zentaris. The loss of a major commercialization partner disrupts revenue streams, making it crucial for the company to secure new partnerships to mitigate these effects[1][4].

Capital Management

Aeterna Zentaris is managing its cash resources carefully, adopting a balanced and de-risked development approach. The company believes it has sufficient funds to meet its cash needs into 2025, based on current projections[3].

Clinical Trials and Regulatory Developments

DETECT Trial

Aeterna Zentaris is conducting the DETECT clinical trial for the diagnosis of CGHD. The trial has shown significant progress, with patient recruitment advancing and additional countries involved in the trial. The company is optimistic about completing the trial by the end of the year[3][4].

Regulatory Validation

The U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance for Aeterna's U.S. patent application for macimorelin, further validating its commercial potential. This development is seen as a positive indicator for the drug's future in the market[4].

Market Challenges

Global Instability

The global pandemic of COVID-19 and the war in Ukraine have introduced significant uncertainties, potentially affecting Aeterna Zentaris's planned operations. These global events can impact supply chains, regulatory processes, and overall market stability[1][3].

Competition and Market Dynamics

The biopharmaceutical market is highly competitive, with companies like Novo Nordisk dominating various segments. Aeterna Zentaris must navigate this competitive landscape while securing new partnerships and advancing its clinical trials[2][5].

Financial Performance and Projections

Revenue and Operating Profit

Aeterna Zentaris's financial performance is heavily dependent on the success of Macrilen and its other pipeline products. The company's ability to raise capital and secure financing is crucial for continuing its operations. Despite the challenges, Aeterna Zentaris reported a stable financial position, with a focus on optimizing capital and human resources[3].

Cash Flow and Funding

The company's cash flow management is critical, especially given the temporary disruption in Macrilen sales. Aeterna Zentaris is confident in its ability to manage cash responsibly and meet its anticipated cash needs into 2025[3].

Future Prospects

Strategic Partnerships

Securing new development and commercialization partners is pivotal for the re-launch of Macrilen in the U.S. and other unpartnered territories. Aeterna Zentaris is actively engaged in discussions with potential partners to capture the full value of macimorelin[3][4].

Expanding Indications

The ongoing DETECT trial and potential approval for CGHD could expand Macrilen's market reach. Successful outcomes from these trials could significantly enhance the drug's commercial potential and contribute to Aeterna Zentaris's financial growth[3][4].

Key Takeaways

• Temporary Discontinuation: Macrilen sales in the U.S. were temporarily discontinued due to the end of the license agreement with Novo Nordisk.
• New Partnerships: Aeterna Zentaris is actively seeking new commercialization partners for Macrilen in the U.S. and Canada.
• Clinical Trials: The DETECT trial is progressing well, with significant patient recruitment and regulatory validation.
• Financial Management: The company is managing its cash resources carefully and is confident in meeting its cash needs into 2025.
• Market Challenges: Global instability and competitive market dynamics pose significant challenges.
• Future Prospects: Securing new partnerships and expanding indications through successful clinical trials are crucial for future growth.

FAQs

What is Macrilen used for?

Macrilen (macimorelin) is used for the diagnosis of adult growth hormone deficiency (AGHD) and is under investigation for the diagnosis of childhood onset growth hormone deficiency (CGHD)[1][4].

Why were Macrilen sales discontinued in the U.S.?

Macrilen sales were temporarily discontinued in the U.S. due to the end of the license agreement with Novo Nordisk, effective May 23, 2023[1][4].

Who is currently commercializing Macrilen in the UK and EEA?

Pharmanovia has acquired the exclusive rights to commercialize GHRYVELIN (macimorelin) in the UK and EEA[4].

What is the status of the DETECT clinical trial?

The DETECT trial is making significant progress, with patient recruitment advancing and additional countries involved. The trial is expected to be completed by the end of the year[3][4].

How is Aeterna Zentaris managing its financial resources?

Aeterna Zentaris is managing its cash resources carefully, adopting a balanced and de-risked development approach, and believes it has sufficient funds to meet its cash needs into 2025[3].

Sources

1. Aeterna Zentaris Provides Update on Macrilen® - GlobeNewswire
2. Novo Nordisk Annual Report 2021
3. Aeterna Zentaris Outlines Progress on Development Pipeline ... - BioSpace
4. Aeterna Zentaris Provides Update on Macrilen® (Macimorelin ... - BioSpace
5. NOVO B Q1-2019 Earnings Call - Alpha Spread