Lyrus Receives US FDA Approval for Critical UTI Treatment in the US

The U.S. Food and Drug Administration (FDA) has approved Lyrus Life Sciences’s Abbreviated New Drug Application (ANDA) for ‘Methenamine Hippurate Tablets USP, 1 gram’, an AB-rated, substitutable generic version of Hiprex® from Validus Pharmaceuticals LLC which is indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary.

Lyrus Research and Development Center, Bengaluru

Lyrus is a full-stack pharmaceutical company with HQ in Bangalore, focused on research and development in the complex generic space for global pharma majors. Lyrus has a dedicated, certified and well-equipped research facility with a pool of 80+ scientists having extensive experience in all aspects of the pharmaceutical development process.

Lyrus has developed nearly 80 molecules (130+ SKUs) for UK and EU markets out of which multiple submissions have already been approved. We continue to extend the dossiers to other parts of EU member states and other markets through additional bridging works. 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 and received the first ANDA approval on 1st Dec 2023 through first cycle of approval.

Based on Geographic analysis, North America accounts for the largest consumption of Methenamine Hippurate due to the increasing cases of urological procedures. Europe accounts for the second-largest market due to increasing awareness of urinary tract infections and the presence of a wide distribution network. APAC 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.

Mr. C. P. Bothra, Chairman of Lyrus said, “The FDA approval of Lyrus’s Abbreviated New Drug Application (ANDA) for ‘Methenamine Hippurate Tablets USP, 1 gram’, an AB-rated, substitutable generic version of Hiprex® from Validus Pharmaceuticals LLC marks a significant landmark for our company being a FIRST ANDA for us in the US Market, proving our capabilities in bringing complex generics and difficult-to-manufacture products to market, and further our commitment to providing access to quality medicines, meeting the patient needs.

Mr. Hemanth Bothra, Managing Director of Lyrus said while congratulating the Team Lyrus that, “The Community-associated UTI (CA-UTI) incidence is 0.7% and the primary risk factors are age, history of UTI and diabetes. Globally, around 150 million individuals develop UTIs. The highest incidence of symptomatic infections is prevalent in young women aged 18 to 24 years, with one-third to one-half of women reported having at least one UTI by age 32. In the U.S., 70–80% of complicated UTIs are attributable to catheters, resulting in 1 million cases per year. Thus, the market needs are increasing and are predicted to increase globally paving way for Lyrus to be a meaningful player in the market. As part of its ANDA, Lyrus submitted rigorous side-by-side analyses, including characterization data, which demonstrated that Lyrus’s Methenamine Hippurate Tablets USP, 1 gram have the same active ingredient, dosage form, route of administration and strength as their branded counterpart. Lyrus’s Methenamine Hippurate Tablets USP, 1 gram are available by prescription only.”

According to IMS sales data, the US market was estimated to be worth USD 57 million, and rising UTI awareness is expected to drive this value upward. The FDA-approved Lyrus’s Abbreviated New Drug Application (ANDA) is licensed to Jubilant Cadista Pharmaceuticals Inc. for marketing and distribution in the USA. The product will be produced in India at Lyrus’s approved CMO, and we anticipate that it will hit the market within this financial year.

In addition, Lyrus has filed this product 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.