INDIA – Lyrus Life Sciences has earned approval from the U.S. Food and Drug Administration (FDA) for its prescription drug for complicated urinary tract infections (UTIs).

In a historic move, Lyrus submitted an ANDA for the review and potential approval of its Methenamine Hippurate Tablets USP, 1 gram.

The FDA has approved Methenamine Hippurate as a prophylactic or suppressive treatment for frequently recurring UTIs when long-term therapy is considered necessary.

“The FDA approval of Lyrus’ ANDA for Methenamine Hippurate Tablets USP, 1 gram, marks a significant landmark for our company being a FIRST ANDA for us in the US Market,” Mr. C. P. Bothra, the Chairman of Lyrus said in a statement.

Mr. C. P. Bothra underscored that the FDA approval attests to Lyrus’ capabilities in bringing complex generics and difficult-to-manufacture products to market.

He further said that Lyrus remains committed to increasing access to quality medicines to meet patient needs worldwide.

What’s more, the FDA-approved Lyrus’ ANDA is licensed to Jubilant Cadista Pharmaceuticals Inc. for marketing and distribution in the United States of America.

The product will be produced in India at Lyrus’ approved contract manufacturing organization (CMO) facility as the company plans to begin marketing it within the current financial year.

This development comes when Lyrus has developed nearly 80 molecules for the United Kingdom and the European Union markets, out of which multiple submissions have already been approved.

Headquartered in Bangalore, Lyrus Life Sciences focuses on research and development in the complex generic space for global pharma majors.

The full-stack pharmaceutical company has a dedicated, certified, and well-equipped research facility. Moreover, Lyrus has tapped a pool of more than 80 scientists who have extensive experience in all aspects of the pharmaceutical development process.

Identifying patient needs, Mr. Hemanth Bothra, Managing Director of Lyrus, said: “The market needs are increasing and are predicted to increase globally paving the way for Lyrus to be a meaningful player in the UTI treatment market.”

Mr. Hemanth Bothra further outlined that Lyrus’ Methenamine Hippurate Tablets USP, 1 gram are available by prescription only.

The Bangalore-based firm is looking to extend the dossiers of nearly 80 molecules to other parts of the EU member states and various markets through additional bridging works. 

Notably, Europe accounts for the second-largest market for Methenamine Hippurate due to increasing awareness of UTIs and the presence of a wide distribution network.

The Asia-Pacific region is expected to account third largest for the consumption of Methenamine Hippurate due to the constant rise in chronic infections among women and increasing cases of postmenopausal UTIs.

The IMS sales data shows that the surge in demand for Methenamine Hippurate continues amid heightened public awareness, with approximately 150 million cases worldwide.

After having extensive product development experience in the UK, EU, and Australia, Lyrus filed the first ANDA to enter the US market early in 2023.

Speaking on the ANDA, Mr. Hemanth said: “Lyrus submitted rigorous side-by-side analyses, which demonstrated that Lyrus’ Methenamine Hippurate Tablets USP, 1 gram, have the same active ingredient, dosage form, route of administration and strength as their branded counterpart.”

The landmark FDA approval presents a unique opportunity for Lyrus to cater to the growing demand for Methenamine Hippurate due to the increasing cases of urological procedures in North America.

On top of this, Lyrus has filed its product, Methenamine Hippurate Tablets USP, 1 gram, in the UK, the EU (Nordic), Australia, and the APAC region, which includes India.

Lyrus anticipates receiving marketing authorization in Q2/Q3 of 2024. This product is expected to generate substantial revenue from the global market.

Moreover, Lyrus’ critical UTI treatment is an AB-rated, substitutable generic version of Hiprex from Validus Pharmaceuticals LLC, a New Jersey-based specialty pharmaceutical company.

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