Viswanath PillaMoneycontrol Bureau Lupin
, India’s third-largest drug maker which posted an impressive Q3 show largely on account of significant contribution from generic version of its diabetic drug Glumetza has warned of an impending competition from rivals for the drug.
Lupin has garnered 77 percent market share for generic Glumetza due to delayed launches of rivals Sun Pharma
and Israel-based Teva copycats of the Glumetza, despite having approvals.
But all that set to change with the launch of Valeant’s authorised generic and the expected launches of Teva and Sun Pharma in the second and third quarters of this calendar year respectively. Lupin fears the competition will lead to price erosion in the coming quarters.
Along with Glumetza, Lupin is also heavily dependent on two other drugs including generic diabetic medication Fortamet and postpartum hemorrhage drug Methergine for its US business.
Analyst estimate the three drug togethers could be contributing around close to half of US sales for the company - posing concentration risk for the company.
In Fortamet - the company already has formidable genericl rival in form of Mylan and more generic players are set to enter with Methergine copycat.
Lupin still beleives it has enough of fire power left to mitigate any loss in revenue from Glumetza and Fortamet.
In a recent earnings call, the company said it expects to maintain EBITDA in the range of 26-28 percent on back of new launches, despite an 8-10 percent value erosion of its base business in US.
The company plans over 25 potential launches in the next 12 months - including some big ones such as as birth-control pill Minastrin 24, HIV drug Epzicom, and Alzheimer's medication Namenda XR.
For Minastrin Lupin has first-to-file status making it eligible for 180-day exclusivity. Minsatrin has sales of USD 300 million in year ended June 2016.
The company also said it is targeting controlled substances products worth USD 20 billion market value going forward much of it coming from the Gavis Pharmaceuticals, which it acquired in July 2015 for USD 880 million (around Rs.5,600 crore), seeking to expand presence in the US generics market.
Lupin said it is ramping up Methergine tablets used in the prevention and management of postpartum hemorrhage (PPH) as part of its branded business. Methergine is the only FDA-approved oral uterotonic and is a preferred oral agent in the management of PPH. Lupin sees Methergine
The company is also spending close to 13 percent of sales on R&D, as it works on building portfolio of complex and niche products, such as respiratory inhalers, biosimilars that are harder to make and command higher prices.
Lupin said it has filed for albuterol metered dose inhaler (MDI) to treat asthma, started clinical work on fourth generation antiretroviral Abacavir (ABC) and is currently testing its biosimilar etanercept on patients in phase-3 trial. Etanercept is used in treatment of autoimmune disorders such as psoriasis and rheumatoid arthritis.