Abametapir manufacturers

About abametapir

Abametapir is a topical pediculicide used to treat head lice infestation. It belongs to the metalloproteinase-inhibitor class and is marketed in the US as Xeglyze (abametapir) lotion 0.74%. The US FDA approved abametapir on 24 July 2020 as a new molecular entity for patients aged 6 months and older. Abametapir manufacturers and suppliers include the originator developer, its licensing partners and generic producers preparing CTD dossiers for markets outside the US.

Abametapir key facts

Abametapir manufacturers and development history

Abametapir was discovered and developed by Hatchtech Pty Ltd, an Australian company, building on research at the University of Melbourne. In September 2015, Hatchtech granted Dr. Reddy's Laboratories exclusive rights for the US, Canada, India, Russia and the CIS, Australia, New Zealand and Venezuela. The deal included a $10 million upfront payment and up to $50 million in pre-commercialization milestones (BioSpace).

FDA approval in 2020 triggered a further $20 million milestone payment to Hatchtech (Dr. Reddy's press release). The US NDA is now held by LNHC, and the FDA lists the branded product as discontinued.

Abametapir API manufacturers are few, because the molecule has a single approved product. The active substance is a small synthetic bipyridine molecule (C12H12N2). Generic abametapir lotion producers, including in South Asia, are developing CTD dossiers for markets where the brand was never launched.

Abametapir dosage form and dossier types

Abametapir is approved in one dosage form: a 0.74% topical lotion supplied in a bottle of about 200 g. It is applied once for 10 minutes to dry hair and scalp, then rinsed off.

Abametapir dossiers are typically prepared in CTD format. A CTD dossier can be adapted to EU CTD, ACTD (ASEAN) and most Gulf, African and Latin American requirements. A US generic filing would need an abametapir ANDA with Paragraph IV or patent-expiry certifications against the Orange Book patents. Developers should plan for bioequivalence or clinical endpoint studies, as is common for topical products.

Abametapir regulatory and patent status

The FDA approved Xeglyze under NDA 206966 on 24 July 2020 (FDA summary review). Approval was based on two phase 3 trials with 704 subjects. Lice-free rates through day 14 were 81.1% and 81.8% with abametapir, versus 50.9% and 47.2% with vehicle.

Two US patents cover the product. US 7,812,163 expires on 28 October 2026, and US 10,292,389 expires on 17 December 2034 (Drugs.com). The 5-year new chemical entity exclusivity ended in July 2025. No generic abametapir has been approved in the US.

No EMA marketing authorization for abametapir was found as of October 2026. The EU and most emerging markets therefore remain open for a first abametapir marketing authorization, subject to local patent checks.

Abametapir mechanism of action and therapeutic use

Abametapir inhibits metalloproteinases, enzymes that head lice need for egg development and survival. Blocking them targets both live lice and egg development. Abametapir lotion is indicated for head lice infestation in patients 6 months of age and older, as part of an overall lice-management programme.

The formulation contains benzyl alcohol and is not recommended under 6 months of age. Abametapir inhibits CYP3A4, CYP2B6 and CYP1A2, so the label advises avoiding substrates of these enzymes for 2 weeks after use. Related head lice treatments include ivermectin lotion, spinosad, permethrin and malathion.

Abametapir licensing and sourcing

Abametapir licensing partners and suppliers can offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA or WHO GMP), dossier format and readiness, and target-market coverage. Current abametapir lotion dossiers and supplier contacts are listed on the Pipelinepharma marketplace.

Frequently asked questions about abametapir

Who manufactures abametapir?

Abametapir was developed by Hatchtech Pty Ltd in Australia and licensed to Dr. Reddy's Laboratories in 2015. The US NDA for Xeglyze is now held by LNHC. Generic abametapir lotion manufacturers, including in South Asia, are developing CTD dossiers for markets outside the US.

What is abametapir used for?

Abametapir lotion 0.74% is used to treat head lice infestation in patients aged 6 months and older. It is applied once for 10 minutes to dry hair and scalp, then rinsed off. It works by inhibiting metalloproteinases that lice need for egg development and survival.

Is there a generic version of abametapir?

No generic abametapir is approved in the US as of October 2026. US patent 7,812,163 expires on 28 October 2026, and US patent 10,292,389 runs to 17 December 2034. Generic dossiers are being developed for markets where Xeglyze was never authorized.

Is an abametapir CTD dossier available?

Yes. Abametapir lotion 0.74% dossiers in CTD format are offered for licensing by generic developers. A CTD dossier can be adapted for EU, ACTD and most emerging-market agencies. Buyers should confirm bioequivalence or clinical bridging requirements for each target market.

Is abametapir approved in Europe?

No EMA marketing authorization for abametapir was found as of October 2026. The only verified approval is the US FDA approval of Xeglyze in July 2020. This makes the EU a potential first-entry market for an abametapir marketing authorization.

What dosage forms of abametapir exist?

Abametapir is approved in one form and strength: topical lotion 0.74%, in a bottle of about 200 g for single use. No shampoo, gel or other abametapir forms have been approved.