Concerns over weakening demand for Indian pharmaceutical (pharma) drugs in the US - their largest export market - have weighed heavily on investor sentiment this year. While the Nifty 50 has gained 6.02 per cent year - to - date (as on September 15), the Nifty Pharma index has declined 5.18 per cent, National Stock Exchange data shows.
Any potential tariffs on pharmaceutical imports into the US are unlikely to impact the credit profiles of Indian firms except for a short-term pricing blip, according to a report by India Ratings and Research (Ind-Ra). The report stated that the US generics market contributes around 35 per cent to the total revenue of the leading Indian pharma firms.
The Indian pharmaceutical industry is likely to benefit from a major wave of patent expiries in the US, as small-molecule drugs worth $63.7 billion are expected to go off-patent between 2025-29, a 65 per cent rise over the previous five years, according to a report by Antique stock broking limited.
India's largest drug maker Sun Pharmaceutical on Thursday posted a decline of 19 per cent year-on-year (Y-o-Y) for its consolidated net profit for the fourth quarter of the financial year 2025 (Q4FY25) at Rs 2,149.8 crore. Meanwhile, its revenue from operations rose by 8 per cent at Rs 12,958.8 crore.
Gland Pharma beat muted expectations for Q2FY25. There was increased Ebitda (Earnings before interest, taxes, depreciation and amortisation) loss at Cenexi, the CRAM subsidiary. However, overall Ebitda margin was better than expectations at 21.1 per cent. But given two years of earnings decline in FY23 and FY24, the business may have bottomed and upper-teens EPS (earnings per share) growth looks possible over next two financial years.
Glenmark Pharmaceuticals Ltd on Tuesday said it has acquired the approved generic versions of certain over-the-counter drugs from Wockhardt Ltd in the US. The acquisition by the company's fully-owned subsidiary Glenmark Pharmaceuticals Inc, USA includes the approved abbreviated new drug applications (ANDAs) for famotidine tablets, 10 mg and 20 mg used to treat and prevent ulcers in the stomach and intestine, the company said in a statement. The company, however, did not disclose the financial details.
Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
Drug shortages in the US are at an all-time high, and price erosion has stabilised, which could benefit Indian pharmaceutical (pharma) companies with a US focus, according to analysts. Nuvama Research analysts said that US price erosion seems to have normalised to its old levels of 6-8 per cent and volumes are picking up with easing of inventory. Similarly, an ICICIdirect analyst noted: "Price erosion intensity has now moderated to a single digit and is expected to tone down a
The drug is licensed to Ranbaxy Laboratories from Cipher Pharmaceuticals Inc of Mississauga, Ontario. It is currently protected by two issued patents listed in the FDA's approved drug products list, which expire in September 2021, the company said in a statement.
The combined sales of the branded versions of the products in the US is about $3.5 billion.
Sun Pharmaceutical Industries said it has received approval from US health regulator to market generic Clarinex tablets and Tiazac capsules, used in treating nasal allergies and hypertension, respectively, in the American market.
Hyderabad, Mar 28 (PTI) Dr Reddy's Laboratories Limited has launched Levocetirizine tablets (5mg), a bio-equivalent generic version of Xyzal tablets in the USA market, the company said on Monday.
In 2012, drugs worth $35 billion went off-patent in the US, while the market size of drugs which will see patent expiry in 2013 will halve to $17 billion.
United States Food and Drug Administration (USFDA) has given final approval to Glenmark Generics Inc for their abbreviated new drug application (ANDA) for Norgestimate and Ethinyl Estradiol tablets USP in the strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg, the company said in a statement.
Orchid Chemicals & Pharmaceuticals on Monday said it has received US health regulator's approval to sell anti-epileptic levetiracetam tablets in the American market.
Ranbaxy's hope of a windfall from the $7-billion Lipitor market in the US is shining again. The US Food and Drugs Administration (USFDA) has taken a strong stance against US-based Mylan, which had opposed FDA's decision to allow approval to Ranbaxy's generic version of Lipitor.
The company has received a tentative approval for the company's abbreviated new drug application for Eszopiclone tablets from the US Food and Drug Administration, Lupin said in a filing to the Bombay Stock Exchange.
Drug-maker Ranbaxy Laboratories on Thursday said it has received the US health regulator's approval to market Quinapril Hydrochloride and Hydrochlorothiazide tablets, used in treatment of high blood pressure, in different strengths in America.
AstraZeneca on Wednesday announced that it had filed separate patent infringement actions in the United States District Court, Delaware, against seven generic drug manufacturers, which have submitted abbreviated new drug applications (ANDAs) with the US Food and Drug Administration (FDA) seeking marketing authorisation for Crestor.
US-based Abbott Laboratories has sued Sun Pharmaceutical Industries and Ranbaxy Laboratories in courts there for challenging the patents of its cholesterol-lowering drugs, Niaspan and TriCor, respectively, in separate infringement suits.
But the newer entrants prove nimbler than the slowing pioneers.
Cephalon, a US-based drug maker, has filed a lawsuit against Lupin Ltd and its US subsidiary Lupin Pharmaceuticals for challenging the patents on its sleep disorder drug Nuvigil.
Pharmaceutical majors like Ranbaxy, Dr Reddy's Lab, Wockhardt, Glenmark and Sun Pharma are now treading a careful patent litigation path in the US market to expand their generic business instead of the aggressive patent challenges they pursued until a few years ago.
GlaxoSmithKline has filed a lawsuit in a United States court against Dr Reddy's Laboratories alleging infringement of patent rights of a generic version of 'Imitrex' drug, used for the treatment of migraine.
The Rs 1,027-crore (Rs 10.27 billion) company has filed 13 abbreviated new drug applications and 22 drug master files with the US Food and Drug Administration and regulatory agencies in Europe for supply of formulations and active pharmaceutical ingredients. Some of the ANDAs challenge innovator patents and the company's strategy will be to partner with established companies in the US and Europe for marketing formulations, said Pranav Amin, director, Alembic.
Eli Lilly and Company, the US-based multinational pharmaceutical major, has sued Sun Pharmaceuticals in the US, alleging the company infringed its patent on Gemzar, a blockbuster cancer drug.
The Finland-based drug major Orion Corporation has filed a lawsuit in the United States against domestic drug major Wockhardt for challenging the patents on its brand Stalevo, used for the treatment of Parkinson's disease.
Pharma major Orchid Chemicals & Pharmaceuticals on Monday said USFDA has completed inspection of its state-of-the-art formulations facility located at Irungattukottai in Chennai.
The company has already received approval from the US Food & Drug Administration for marketing clarithromycin tablets.
In comparison, Indian companies received only 23 out of 139 final approvals (16.54 per cent) in the corresponding period in 2006.
Dr Reddy's Laboratories Ltd filed a lawsuit seeking declaratory judgement against Pfizer in United States District Court for the District of New Jersey regarding its Abbreviated New Drug Application for Sertraline HCl.
Lupin Ltd on Thursday said it has received USFDA approval for its Abbreviated New Drug Application for multiple strengths of antibiotic Cephalexin capsules.
Global pharma firm AstraZeneca on Tuesday said it had filed a lawsuit in the United States District Court of New Jersey
Cipla has got tentative approval from the USFDA for its abbreviated new drug application for anti-HIV/AIDS drug Slamivudine.
Ranbaxy Laboratories on Thursday said it had received Abbreviated New Drug Application approval from the US Food and Drug Administration to manufacture and market Loratidine
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