Abametapir - Generic Drug Details

What are the generic sources for abametapir and what is the scope of freedom to operate?

Abametapir is the generic ingredient in one branded drug marketed by Hatchtech and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abametapir has thirty-six patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for abametapir

International Patents:	36
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	6
Patent Applications:	489
What excipients (inactive ingredients) are in abametapir?	abametapir excipients list
DailyMed Link:	abametapir at DailyMed

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

Constraining patent/regulatory exclusivity:

10,292,389

Dosage:

LOTION;TOPICAL

^*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 abametapir

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

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 2
Hatchtech Pty Ltd	Phase 2
Syneos Health	Phase 3

See all abametapir clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for abametapir

P03AX	Other ectoparasiticides, incl. scabicides
P03A	ECTOPARASITICIDES, INCL. SCABICIDES
P03	ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for abametapir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No	7,812,163		Y
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020		DISCN	Yes	No	10,292,389		Y

Expired US Patents for abametapir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020	8,212,038
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020	9,839,631
Hatchtech	XEGLYZE	abametapir	LOTION;TOPICAL	206966-001	Jul 24, 2020	9,357,783

International Patents for abametapir

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1169045	用於控制體外寄生蟲的方法和組合物 (METHOD AND COMPOSITIONS FOR CONTROLLING ECTOPARASITES)
Denmark	2457582
China	1822854	Methods and compositions for controlling ectoparasites
China	101810613	Prevention and cure method for ectoparasite and compounds thereof
New Zealand	544295	Methods and compositions for controlling ectoparasites using bipyridine derivatives and analogs
Japan	2007505032

Market Dynamics and Financial Trajectory for Abametapir (Xeglyze)

Introduction

Abametapir, marketed under the brand name Xeglyze, is a novel pediculicidal metalloproteinase inhibitor approved by the U.S. Food and Drug Administration (FDA) on July 27, 2020, for the topical treatment of head lice infestations in patients 6 months of age and older[4].

Market Need and Competition

Head lice infestations are a common problem, particularly among children, and the market for treatments has been dominated by products like permethrin and pyrethrins/piperonyl butoxide. However, these treatments often require multiple applications and have seen rising resistance rates, creating a need for more effective and convenient solutions. Abametapir fills this gap with its single-application efficacy and novel mechanism of action, targeting metalloproteinase enzymes critical for the survival and hatching of head lice eggs[1].

Regulatory Approval and Commercialization

The FDA approval of Xeglyze marked a significant milestone, triggering a $20 million pre-commercialization milestone payment to Hatchtech Pty Ltd., the original developer of the drug. Dr. Reddy's Laboratories, which acquired the rights, is working to commercialize the product through partnerships[4].

Clinical and Pharmacological Advantages

Abametapir's unique mechanism as a metalloproteinase inhibitor provides superior ovicidal activity, allowing for a single treatment application. This contrasts with traditional treatments that often require a second application 7-10 days after the first to ensure all lice are eliminated. The drug's efficacy and convenience are expected to drive market adoption[1].

Pharmacokinetics and Safety Profile

Clinical pharmacology studies have shown that abametapir has a favorable safety profile. The drug is extensively metabolized, primarily by CYP1A2, to its carboxylate metabolite, which is slowly cleared from the plasma. Despite high protein binding, the drug's systemic exposure decreases with increasing age, and it is generally well-tolerated. However, it contains benzyl alcohol, which poses risks for neonates and low birth weight infants, necessitating careful administration in pediatric patients[1][5].

Financial Implications of Approval

The approval of Xeglyze is expected to generate significant revenue for Dr. Reddy's Laboratories and its partners. The market for head lice treatments is substantial, and the introduction of a more effective and convenient product is likely to capture a significant share. The $20 million milestone payment to Hatchtech is just the beginning, as commercialization and sales are anticipated to bring in much higher revenues over time[4].

Market Penetration and Adoption

Given its advantages over existing treatments, Xeglyze is poised for strong market penetration. Healthcare providers and parents are likely to prefer a single-application treatment with high efficacy, reducing the need for follow-up treatments and improving patient adherence. This could lead to a rapid increase in prescriptions and over-the-counter sales.

Pricing and Reimbursement

The pricing strategy for Xeglyze will be crucial in determining its market success. While the exact pricing details are not publicly available, the drug's unique benefits and the lack of similar products on the market may justify a premium price. Reimbursement policies by insurance providers will also play a significant role in its adoption, with favorable coverage likely to enhance its market dynamics.

Potential for Resistance and Long-Term Market Impact

One of the key advantages of abametapir is its novel mechanism of action, which may help mitigate the development of resistance seen with other treatments. This could ensure a longer market lifespan and continued demand for the product, unlike older treatments that face diminishing efficacy due to resistance[1].

Partnerships and Distribution

Dr. Reddy's Laboratories is working through partnerships to commercialize Xeglyze. Effective distribution and marketing strategies will be essential in reaching both healthcare providers and consumers. Strong partnerships can facilitate broader market access and accelerate the drug's adoption.

Regulatory and Clinical Studies Support

The FDA's approval was based on comprehensive clinical and nonclinical studies that demonstrated the safety and efficacy of abametapir. These studies, including reproductive and developmental toxicology assessments, have provided a robust foundation for the drug's market presence[3][5].

Consumer Awareness and Education

Educating consumers and healthcare providers about the benefits of Xeglyze will be critical for its market success. Campaigns highlighting its single-application efficacy, safety profile, and the convenience it offers are likely to drive adoption and market growth.

Key Takeaways

• Novel Mechanism: Abametapir targets metalloproteinase enzymes, offering superior ovicidal activity.
• Single Application: Unlike many other treatments, Xeglyze requires only one application.
• Regulatory Approval: FDA-approved on July 27, 2020, for patients 6 months and older.
• Commercialization: Dr. Reddy's Laboratories is commercializing the product through partnerships.
• Financial Potential: Significant revenue expected due to market demand and competitive advantages.
• Pricing and Reimbursement: Pricing strategy and insurance coverage will influence market adoption.
• Long-Term Impact: Novel mechanism may reduce resistance development, ensuring long-term market presence.

FAQs

What is abametapir used for?

Abametapir, marketed as Xeglyze, is used for the topical treatment of head lice infestations in patients 6 months of age and older.

How does abametapir work?

Abametapir works by inhibiting metalloproteinase enzymes critical for the survival and hatching of head lice eggs, providing superior ovicidal activity.

Is abametapir safe for all ages?

Abametapir is approved for use in patients 6 months of age and older. However, it should be avoided in patients under 6 months due to the risk of benzyl alcohol toxicity.

Does abametapir require multiple applications?

No, abametapir is effective with a single application, unlike many other head lice treatments that require follow-up applications.

Who developed and commercialized abametapir?

Abametapir was developed by Hatchtech Pty Ltd. and is being commercialized by Dr. Reddy's Laboratories through partnerships.

Sources

1. DrugBank: Abametapir: Uses, Interactions, Mechanism of Action.
2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: Meeting Documents.
3. FDA: Center for Drug Evaluation and Research - Xeglyze (abametapir) NDA Submission.
4. Business Wire: Dr. Reddy's Laboratories received approval of XEGLYZE (abametapir) lotion.
5. FDA: Xeglyze lotion - FDA Media.

Last updated: 2024-12-18