The start of FY21 coincided with the early days of the COVID-19 pandemic. Given the uncertainty, we recognized the need to engage in constant communication with our customers to understand the implications of the pandemic and to plan accordingly to ensure continuity of supply of essential medicines. Our strong relationships with our customers and our agile supply chain enabled us to anticipate and plan for the initial surge in demand of products such as Oseltamivir and Cephalosporins in addition to products like Azithromycin, when it became an early treatment option for COVID-19. In addition, we increased the safety stock for other critical primary care medicines and chronic medicines such as those for the management of cardiovascular disease and diabetes.
In FY21, US sales contributed INR 53,730 million to the company’s revenue, accounting for 36% of the overall sales. This was largely anchored by strong performance of our in-line products such as Famotidine, Lisinopril and Levothyroxine. In September 2020, we launched Albuterol, which is indicated for the treatment of COPD and asthma and has been used as a key rescue product for COVID-19 treatment in the US. We expect full year revenues from Albuterol to drive growth for Lupin in the coming year. Taking strides towards our first biosimilar launch in the US, we filed our BLA for Peg-filgrastim, which we hope to successfully commercialize in FY23. During the year, we filed 15 ANDAs and 1 BLA and received 19 ANDA approvals. ANDA filings for the year include 5 confirmed exclusive first-to-file products (FTFs) and 4 shared FTF products.
Our BLA filing for biosimilar Peg-filgrastim was achieved post successful completion of due development studies, execution of process validation batches and comprehensive analytical assessment. We also initiated the Global Phase III study for biosimilar Ranibizumab for the US.
In FY21, we settled 11 pending US litigations and 1 pending UK litigation. Further, we received favorable US court decisions in our Kerydin® and Tecfidera® patent challenges and a favorable German court decision in our Truvada® SPC challenge.
Our Specialty women’s health business was impacted by COVID-19 headwinds due to a very large drop in physician visits. Last year, we filed a sNDA for trichomoniasis for Solosec®, our key women’s health product indicated for the treatment of bacterial vaginosis (BV) and received the approval in FY22. Early in the fiscal, Solosec® received preferred status on Express Scripts National Preferred Formulary, one of the largest commercial formularies in the US. This will ensure that Solosec® is available at a lower out-ofpocket cost.
During the year, we also reorganized our specialty organization to streamline sales efforts and have inked partnership with key players in the Women’s Health space.
With mass vaccination across the US, we believe that sales in FY2021-22 will revert to pre-COVID-19 levels. We are confident that an improved US market environment, resolution of USFDA issues at specific facilities, and ramp-up of key product launches, in addition to continued execution on Albuterol commercialization, will accelerate our growth throughout the next fiscal.
Data Source: IQVIA MAT March 2021