LIKMEZ Drug Patent Profile

When do Likmez patents expire, and what generic alternatives are available?

Likmez is a drug marketed by Saptalis Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has five patent family members in five countries.

The generic ingredient in LIKMEZ is metronidazole. There are eighteen drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Likmez

A generic version of LIKMEZ was approved as metronidazole by TEVA PHARMS USA on November 6^th, 1984.

Summary for LIKMEZ

International Patents:	5
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for LIKMEZ
What excipients (inactive ingredients) are in LIKMEZ?	LIKMEZ excipients list
DailyMed Link:	LIKMEZ at DailyMed

See drug prices for LIKMEZ

Pharmacology for LIKMEZ

Drug Class

Nitroimidazole Antimicrobial

US Patents and Regulatory Information for LIKMEZ

LIKMEZ is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Saptalis Pharms	LIKMEZ	metronidazole	SUSPENSION;ORAL	216755-001	Sep 22, 2023		RX	Yes	Yes	11,541,035		Y

International Patents for LIKMEZ

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3768321	FORMULATIONS ORALES DE MÉTRONIDAZOLE ET MÉTHODES DE TRAITEMENT D'UNE INFECTION FAISANT APPEL À CELLES-CI (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME)
Brazil	112020014376	composição farmacêutica oral, e, método para tratar uma infecção em um paciente.
World Intellectual Property Organization (WIPO)	2019140516
Canada	3087789	FORMULATIONS ORALES DE METRONIDAZOLE ET METHODES DE TRAITEMENT D'UNE INFECTION FAISANT APPEL A CELLES-CI (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME)
Mexico	2020007494	FORMULACIONES ORALES DE METRONIDAZOL Y METODOS DE TRATAMIENTO DE UNA INFECCION CON LAS MISMAS. (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME.)

Supplementary Protection Certificates for LIKMEZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209

Market Dynamics and Financial Trajectory for LIKMEZ (ATI-1501)

Introduction to LIKMEZ

LIKMEZ, also known as ATI-1501, is a taste-masked liquid oral suspension formulation of the antibiotic metronidazole. This innovative formulation was developed by Appili Therapeutics Inc. and has recently received FDA approval, marking a significant milestone in addressing adherence issues for patients with difficulty swallowing or high taste sensitivities[1][3][4].

Market Need and Target Population

Metronidazole is a widely used antibiotic, with over 10 million oral prescriptions written each year in the U.S. alone. However, traditional tablet forms of metronidazole often pose challenges for patients with dysphagia or those who are sensitive to its bitter, metallic taste. LIKMEZ addresses these issues by providing a ready-to-use, strawberry peppermint flavored liquid suspension that does not require refrigeration and has a 24-month shelf life[1][4].

FDA Approval and Regulatory Landscape

On September 25, 2023, the FDA approved LIKMEZ (ATI-1501) for the treatment of trichomoniasis and anaerobic bacterial infections in adults, as well as amebiasis in adults and pediatric patients. This approval is under the NDA505(b)(2) pathway, which allows for a faster and more streamlined regulatory process for drugs that are modifications of existing approved drugs[1][4].

Commercialization and Partnerships

Appili Therapeutics has partnered with Saptalis Pharmaceuticals, LLC, for the commercialization of LIKMEZ. Saptalis is responsible for overseeing the regulatory review, manufacturing, and commercialization of the product in the U.S., Europe, and Latin America. This partnership includes multiple milestone payments and royalties to Appili based on the sales of LIKMEZ[1][2][4].

Financial Impact and Milestone Payments

The FDA approval of LIKMEZ has significant financial implications for Appili Therapeutics. The company has already received $600,000 in milestone payments in fiscal 2024 and anticipates additional sales-based milestone payments and royalties from Saptalis. These payments are expected to contribute substantially to Appili's revenue, particularly as Saptalis launches the product in various regions[2][3].

Revenue Projections

While Appili Therapeutics has not reported significant revenue from LIKMEZ yet, the company's financial outlook is expected to improve with the commercialization of the drug. Zacks Investment Research estimates that Appili will continue to see minimal revenue in the short term but anticipates growth as milestone payments and royalties from Saptalis materialize[1].

Government Support and Additional Funding

In addition to the revenue from LIKMEZ, Appili Therapeutics has secured a contract with the U.S. Air Force Academy (USAFA) for funding the development of ATI-1701, another pipeline product. This funding, which totals at least $14 million, will support early-stage development and regulatory activities for ATI-1701, further bolstering Appili's financial position[1][2].

Financial Performance and Operational Results

As of December 31, 2023, Appili Therapeutics reported a net loss and comprehensive loss of $0.2 million, which is $2.4 million lower than the same period in the previous year. This reduction is attributed to an increase in milestone revenue, government assistance, and a decrease in general and administrative expenses. However, the company's cash position has decreased from $2.5 million on March 31, 2023, to $0.6 million as of December 31, 2023[2][3].

Challenges and Opportunities

Despite the positive developments, Appili Therapeutics faces challenges such as increasing research and development expenses and financing costs. However, the company's strategic partnerships and government support are critical in mitigating these risks. The approval and commercialization of LIKMEZ present a significant opportunity for Appili to address unmet patient needs and generate substantial revenue[2][5].

Competitive Landscape

LIKMEZ is the first and only FDA-approved ready-to-use oral liquid metronidazole in the U.S. market, giving it a unique position in addressing adherence issues. This differentiation is expected to drive market adoption and preference among healthcare providers and patients, potentially leading to a strong market presence for LIKMEZ[4].

Patient Adherence and Compliance

The novel formulation of LIKMEZ addresses common compliance and persistency obstacles associated with traditional metronidazole tablets. By providing a taste-masked liquid suspension, LIKMEZ can improve patient adherence, leading to more efficient treatment outcomes and reduced risks of rebound infections[4].

Future Outlook

The future outlook for LIKMEZ is promising, with anticipated growth in revenue from milestone payments and royalties. As Saptalis expands the commercialization efforts to Europe and Latin America, Appili Therapeutics is poised to benefit from a broader market reach. The company's ability to identify and develop innovative products, coupled with strong partnerships and government support, positions it well for long-term success[1][2][4].

Key Takeaways

• FDA Approval: LIKMEZ (ATI-1501) received FDA approval in September 2023 for treating various infections.
• Commercialization: Partnered with Saptalis Pharmaceuticals for commercialization in the U.S., Europe, and Latin America.
• Financial Impact: Anticipated revenue growth from milestone payments and royalties.
• Government Support: Secured funding from the U.S. Air Force Academy for the ATI-1701 program.
• Market Differentiation: First and only FDA-approved ready-to-use oral liquid metronidazole.
• Patient Adherence: Improves compliance and treatment outcomes by addressing taste and swallowing issues.

FAQs

What is LIKMEZ (ATI-1501)?

LIKMEZ (ATI-1501) is a taste-masked liquid oral suspension formulation of the antibiotic metronidazole, developed by Appili Therapeutics Inc.

What are the key benefits of LIKMEZ?

LIKMEZ addresses adherence issues for patients with difficulty swallowing or high taste sensitivities, providing a ready-to-use, flavored liquid suspension that does not require refrigeration.

Who is responsible for the commercialization of LIKMEZ?

Saptalis Pharmaceuticals, LLC, is responsible for the commercialization of LIKMEZ in the U.S., Europe, and Latin America.

What financial benefits can Appili Therapeutics expect from LIKMEZ?

Appili Therapeutics can expect milestone payments and royalties from Saptalis based on the sales of LIKMEZ, contributing significantly to its revenue.

What other pipeline products does Appili Therapeutics have?

Appili Therapeutics is also developing ATI-1701, a novel, live-attenuated vaccine for biodefense, with funding support from the U.S. Air Force Academy.

Cited Sources:

1. Zacks Small-Cap Research: "Appili Therapeutics Inc. (OTCQX: APLIF) Current Price (10/05/23) $0.03 Valuation $0.15 OUTLOOK SUMMARY DATA Risk Level High Type of Stock Small-Value Industry Med-Biomed/Gene" - October 5, 2023.
2. Appili Therapeutics: "Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2024" - February 13, 2024.
3. GlobeNewswire: "Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2024" - February 13, 2024.
4. Biospace: "Kesin Pharma Announces FDA Approval and U.S. Availability of LIKMEZ (Metronidazole) Oral Suspension" - November 14, 2023.
5. GlobeNewswire: "Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2025" - November 14, 2024.