Generic Pharmaceutical and API Research

Lupin’s Generic Pharmaceutical and API Research programs have been the foundation of our growth and evolution as a Global Generic Pharmaceutical powerhouse. FY 2016 was a great year with industry-leading performance in terms of number of filings. The Company continued to make strategic investments for the future having fully operationalized a new Injectable product development laboratory at its global R&D hub in Pune, India. Lupin’s state-of-the-art R&D facility in Coral Springs, Florida was inaugurated in August, 2015. Lupin is now amongst the few pharmaceutical majors with the capability to develop world-class inhalation products.

The Company’s generic pipeline focus is to develop relevant products for advanced markets, specifically the complex ones losing patent protection. A majority of our pipeline is made up of products with high barriers to entry like complexities associated with developing complex formulations, device combinations and clinical trials. Development timelines are often longer and costs are typically much higher than those for other generic drug development programs. These factors help limit the number of companies capable of pursuing such generic products and considerably increase the commercial potential of these products. This is complemented by a comprehensive pipeline of oral solids. Lupin has a balanced pipeline of products which will help Lupin establish even higher levels of leadership as a generics player and will play an important role in building Lupin’s specialty pharmaceutical portfolio in the near future.

Highlights, FY 2016

  • Filed 36 ANDAs (20 oral, 10 dermatology, 2 ophthalmic, 1 inhalation and 3 other products), including 2 First-to-File (FTF) products with the US FDA. The Company received 39 approvals in FY 2016. Cumulative ANDA filings with the US FDA now stand at 343 with 180 approvals received to date. Lupin now has a total of 45 FTF ANDAs, which include 25 exclusive FTF opportunities.
  • 8 MAAs were filed with European regulatory authorities and 3 approvals were received. Cumulative filings with European authorities now stand at 67 with the Company having received 52 approvals to date.
  • Filed 16 US DMFs, taking the cumulative total to 172 DMF filings. Additionally filed 3 EDMF, 2 CEP and 2 Japan DMFs.
  • The team received further milestone payments of USD 3 million for 2 of its products that are being jointly developed with Medicis Pharmaceuticals Corporation, now Valeant.