The U.S. Food and Drug Administration (FDA) has accepted Lyrus Life Sciences’s Abbreviated New Drug Application (ANDA) for ‘Methenamine Hippurate Tablets USP, 1 gram‘, an AB-rated, substitutable generic model of Hiprex from Validus Pharmaceuticals LLC which is indicated for prophylactic or suppressive therapy of often recurring urinary tract infections when long-term remedy is taken into account mandatory.
Lyrus Research and Development Center, Bengaluru
Lyrus is a full-stack pharmaceutical firm with HQ in Bangalore, centered on analysis and growth in the advanced generic house for international pharma majors. Lyrus has a devoted, licensed and well-equipped analysis facility with a pool of 80+ scientists having in depth expertise in all features of the pharmaceutical growth course of.
Lyrus has developed practically 80 molecules (130+ SKUs) for UK and EU markets out of which a number of submissions have already been accepted. We proceed to increase the dossiers to different elements of EU member states and different markets by extra bridging works. After having in depth product growth expertise in the UK, EU and Australia, Lyrus filed the FIRST ANDA to enter the US market early in 2023 and obtained the first ANDA approval on 1st Dec 2023 by first cycle of approval.
Based on Geographic evaluation, North America accounts for the largest consumption of Methenamine Hippurate as a consequence of the rising circumstances of urological procedures. Europe accounts for the second-largest market as a consequence of rising consciousness of urinary tract infections and the presence of a large distribution community. APAC is predicted to account third largest for the consumption of Methenamine Hippurate as a consequence of the fixed rise in continual infections amongst ladies and rising circumstances of postmenopausal UTIs.
Mr. C. P. Bothra, Chairman of Lyrus mentioned, “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 mentioned whereas 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 gross sales information, the US market was estimated to be price USD 57 million, and rising UTI consciousness is predicted to drive this worth upward. The FDA-approved Lyrus’s Abbreviated New Drug Application (ANDA) is licensed to Jubilant Cadista Pharmaceuticals Inc. for advertising and marketing and distribution in the USA. The product will probably be produced in India at Lyruss accepted CMO, and we anticipate that it’s going to hit the market inside this monetary yr.
In addition, Lyrus has filed this product in the UK, the EU (Nordic), Australia, and the APAC area, which incorporates India. Lyrus anticipates receiving advertising and marketing authorization in Q2/Q3 of 2024. This product is predicted to generate substantial income from the international market.
Website: www.lyruslife.com, www.linkedin.com/firm/lyruslife.
