Imported generics have so far managed to escape Trump’s glare likely due to their critical role in keeping US healthcare costs in check. However, Indian pharma is not waiting for the axe to fall, and experts say a multi-pronged defence strategy by key players is already in motion.
IPA also refuted the study's reliance on the FDA Adverse Event Reporting System (FAERS) data, stating that FAERS data is observational and does not prove causation between drugs and adverse events.
Indian companies operate on thin EBITDA margins of 5-15% on average for their base business, even a 10% reciprocal tariff as India charges on US exports would make them unviable, if they fail to pass on the increased import duty on to the US consumer
The trials showed that Molnupiravir reduced the risk of hospitalisation by over 65 percent compared to standard of care medication alone
His advice to young leaders: "Focus on relationships and building trust with your customers, your partners and your employees."
The merger of Pfizer’s Upjohn division and Mylan may not only attempt to solve their problems in the US market but also make inroads into emerging markets, particularly China
Dr Reddy’s generic Suboxone launch is set to be a reality. A much-awaited event, a mounting threat from competitors may limit its benefits
The US FDA appointment is closely watched by Indian pharmaceutical industry which supplies 40 percent of the generic medications consumed in the US. The generic or copycat drugs account for more than 8 in 10 prescriptions. India has 572 US FDA compliant plants -- the highest outside US.
Stocks like Dr Reddy's and Sun Pharma gained around 5 percent on Wednesday. Major Indian pharma companies earn around 15-50 percent revenue from the US market.
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The impact of the Trans-Pacific Partnership (TPP) struck last week between 12 nations, which include the United States but not India, is still being studied by Indian drug makers.
Pharma major Lupin is looking at strengthening its branded portfolio by creating alliances and eyeing strategic brand acquisitions in US markets in 2015-16.
Credit Suisse maintains neutral rating on the stock and expects consensus to cut FY16-17 earnings per share (EPS) by 10-8 percent. "Lupin has shifted gears on complex generics and unlike past practices of adding one vertical a year, Lupin has commenced R&D on several verticals but the benefits are back-ended," it says in a report.
The multinational pharmaceutical company with current market capitalisation of nearly Rs 51,000 crore has a portfolio that includes 2000 products in 65 therapeutic categories with one quality standard globally.
Terming the US as a high growth market for the company, the Mumbai-based firm said it aims to grow at around 25 percent in the world's largest drug market.
A JM financial probe said that the probability of any major action against generic pharma companies accused of inflating generic drug prices is low because such as precedent has not taken place in the past, there is uncertainty on the extent of price increases and cartellization may be difficult to prove.
Indian pharmaceutical companies have an opportunity to capitalise on the patent cliff and gain a greater share of the growing generics market.
The USFDA today approved Ranbaxy‘s drug called Plendil generic, which is used for hypertension. Ranbaxy was expected to be the authorised generic for this particular drug, but it is already genericised and there are already 6-7 players in this market for this particular drug.
Sun Pharmaceutical was prepared to pay USD five billion and USD six billion for Meda to boost its generics business in developed markets.
Hyderabad-based Dr Reddy's fourth quarter consolidated net profit increased 67 percent year-on-year to Rs 571 crore, helped by surge in other income and higher finance income.
Ranbaxy's first quarter consolidated net profit plunged 90 percent to Rs 126 crore, while net sales fell 34 percent to Rs 2,439.8 crore in Jan-March. The company's earnings in the year ago quarter were boosted by launch of generic version of cholesterol lowering drug Lipitor.
Pharma major Glenmark says the operating environment is challenging given the slowdown in India and longer time taken by the US drug regulator for product approvals. It is expecting a 20 percent revenue growth in FY14.
Pharma major Glenmark on Tuesday said its US generics arm has settled a litigation with Janssen Pharmaceuticals over patent actions concerning Norgestimate and Ethinyl Estradiol tablets in various strengths.
Glenmark Pharmaceuticals' US generics drugs subsidiary has received final approval from US Food and Drugs Administration for its abbreviated new drug application (ANDA) to market Montelukast Sodium tablets in 10 mg strength, which are used for the treatment for prophylaxis and chronic treatment of asthma.
Kamal Sharma, MD, Lupin explains to CNBC-TV18 that the 44% growth in the topline was driven primarily by the excellent performance of generics, launch of new products in the US, Japan and India, and the recent signing of a pact to launch Novartis‘ Onbrez brand for asthama.