Latest news with #Xarelto
Business Upturn
6 days ago
- Business
- Business Upturn
Indoco Remedies gets USFDA nod for generic Rivaroxaban tablets; eyes growth in US Market
Mumbai-based Indoco Remedies Ltd. has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to market Rivaroxaban Tablets USP in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg. The product is the generic equivalent of Janssen Pharmaceuticals' blockbuster anticoagulant, Xarelto, and will be manufactured at Indoco's Verna, Goa facility. The approved Rivaroxaban tablets are bioequivalent and therapeutically equivalent to Xarelto and are indicated for the treatment of venous thromboembolism (VTE). This approval marks another milestone in Indoco's push into the US generics market, one of the most lucrative pharmaceutical markets globally. Commenting on the development, Indoco Remedies' Managing Director Aditi Panandikar said, 'Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US.' Indoco Remedies is a fully integrated, research-driven pharmaceutical company with a global footprint, generating over 106 million prescriptions annually in India alone. The company operates 11 manufacturing facilities — seven for finished dosage forms (FDFs) and four for active pharmaceutical ingredients (APIs) — all of which are approved by top global regulatory agencies including the USFDA and UK-MHRA. With a turnover of $180 million and a workforce of more than 6,000 employees, Indoco is known for popular domestic brands such as Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, and Cital. Internationally, the company partners with large generics players to expand its market reach across multiple geographies. The latest USFDA approval strengthens Indoco's product portfolio in the regulated market and could open up significant revenue opportunities as Rivaroxaban continues to be a widely prescribed oral anticoagulant in the US. Disclaimer: This news article is for informational purposes only and does not constitute investment advice. Investors should consult a qualified financial advisor before making investment decisions. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Business Upturn
6 days ago
- Business
- Business Upturn
Why are Indoco Remedies shares up 2% today? Explained
By Aditya Bhagchandani Published on August 13, 2025, 10:05 IST Indoco Remedies Ltd shares climbed over 2% to ₹299.30 in morning trade on Tuesday after the company announced it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban tablets, a generic version of Bayer's blockbuster anticoagulant Xarelto. The approval covers multiple dosage strengths — 2.5 mg, 10 mg, 15 mg, and 20 mg — positioning Indoco to tap into the lucrative US market for blood thinners, which has significant demand due to rising cardiovascular cases. Industry data shows Rivaroxaban sales in the US crossed $2 billion in recent years. Indoco said the launch will be executed through its marketing partner in the US, adding that this development strengthens its complex generics portfolio and enhances its revenue visibility in the American market. The stock's rally reflects investor optimism about the earnings potential from this launch, given that US generics typically offer higher margins than domestic formulations. Disclaimer: This article is for informational purposes only and does not constitute financial advice. Investing in equities involves risks. Please consult a certified financial advisor before making any investment decisions. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Bloomberg
06-08-2025
- Business
- Bloomberg
Bayer Gets Boost From Older Drugs, Corn Seeds in Outlook Lift
Bayer AG benefited from surprisingly strong demand for its aging blockbuster eye and blood-thinning medicines in the second quarter, helping the German company raise its forecast for the year. Sales of the eye treatment Eylea came in at €862 million ($998 million) for the period, exceeding analyst estimates, while blood-thinner Xarelto added another €650 million despite facing new generic competition, according to a statement Wednesday that offered a fuller picture of the company's performance than last week's initial announcement.
Yahoo
27-05-2025
- Business
- Yahoo
1 Top Dividend Stock to Buy for a Lifetime of Passive Income
Johnson & Johnson faces challenges including legal and regulatory troubles, and slow top-line growth. The healthcare leader has a solid and diversified business that can overcome these headwinds. J&J has increased its dividend for 62 consecutive years. 10 stocks we like better than Johnson & Johnson › There are hundreds of dividend stocks on the market, but they don't all offer the same level of security. Some haven't increased their payouts in years. Others may provide irregular dividend hikes, which will likely stop if the economy tanks or company-specific issues hit. Still others have cut their payouts in recent years. These aren't the kind of stocks income seekers are looking for. Instead, dividend investors want corporations that consistently raise their payouts, preferably every year, and are unlikely to stop even when they face headwinds. One company that has what it takes to do that is Johnson & Johnson (NYSE: JNJ). Here's why this longtime dividend payer is worth holding on to for good. Let's start with the bear case for Johnson & Johnson. Over the past few years, it has dealt with several issues. We'll consider three. First, it is still facing a litany of lawsuits related to talc-based products that allegedly gave consumers cancer. The company recently failed to put a lid on most of these lawsuits when a judge stopped its attempt to settle with most plaintiffs. So it looks like this headwind will continue. Second, recent regulatory changes in the U.S. could eventually hurt its revenue. The U.S. Centers for Medicare and Medicaid Services (CMS) now has the authority to negotiate the prices of some of the drugs Medicare spends the most on. The first round of negotiations features three of J&J's medicines: Blood thinner Xarelto, immunosuppressant Stelara, and blood-cancer medicine Imbruvica. All will see significant price cuts for Medicare patients. Third, the company has dealt with relatively slow revenue growth. However, despite all that, Johnson & Johnson looks like an attractive long-term option for dividend-seekers. J&J didn't get to be one of the largest healthcare companies in the world by accident. The company has constantly developed newer and better products in its pharmaceutical and medical-technology businesses. It boasts a deep lineup of medicines across several therapeutic areas, including immunology, oncology, infectious diseases, and neuroscience. It has more than 10 drugs that each generate more than $1 billion in annual sales. Its med-tech unit is also diversified across several areas. Its pipeline features several dozen programs. And the drugmaker constantly earns brand-new approvals or label expansions. In other words, it has an incredibly robust underlying business that's well equipped to handle the challenges it faces. The price cuts for Xarelto, Stelara, and Imbruvica will only take effect next year. And even then, they will have a minimal impact on the company's results because none of these drugs feature in its long-term growth plans. Sales of Stelara and Imbruvica are already declining due to competitive pressure (from generics or otherwise). And while Xarelto's revenue moved in the right direction in the first quarter, the U.S. Food and Drug Administration recently approved the first generic of this medicine. There will be more Medicare price negotiations, and nobody knows yet which drugs they will target. But in the long run, Johnson & Johnson should be able to handle this problem. It can avoid price negotiations by decreasing its exposure to therapies for which Medicare -- a program for the elderly -- spends the most. And that's just one possibility, which the company's deep pipeline and ability to generate consistent cash flow should allow it to do. J&J has been around for more than 100 years; it's had to deal with changes in regulatory regimes before. Although the company's revenue growth has been slow, its recent decision to spin off its consumer health unit to focus on its biopharma and med-tech segments was partly to address that problem. Expect stronger revenue growth as it focuses more on higher-growth opportunities within its two remaining units. Lastly, Johnson & Johnson has a higher credit rating than the U.S. government. Even the barrage of lawsuits has not changed that, which is strong evidence that it has the financial capabilities to handle these challenges. A previous judge shot down J&J's attempt to settle these lawsuits via a bankruptcy maneuver for one of its subsidiaries, partly because the company's robust financial position does not put it at risk of insolvency despite the lawsuits it faces. What about the dividend? Johnson & Johnson is a Dividend King with 62 years of consecutive payout increases under its belt. The healthcare leader should continue hiking its dividend, which now yields a market-beating 3.4% yield, for a long time. Before you buy stock in Johnson & Johnson, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Johnson & Johnson wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $639,271!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $804,688!* Now, it's worth noting Stock Advisor's total average return is 957% — a market-crushing outperformance compared to 167% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 19, 2025 Prosper Junior Bakiny has positions in Johnson & Johnson. The Motley Fool recommends Johnson & Johnson. The Motley Fool has a disclosure policy. 1 Top Dividend Stock to Buy for a Lifetime of Passive Income was originally published by The Motley Fool Sign in to access your portfolio
The Hindu
15-05-2025
- Business
- The Hindu
U.S. FDA nod for Lupin's generic of Janssen Pharma's blood thinner tablets
Drugmaker Lupin has received U.S. Food and Drug Administration (U.S. FDA) approval for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, its generic version of Janssen Pharmaceuticals' blood thinner tablet Xarelto. The product will be manufactured at its Aurangabad facility. The approved product had an estimated annual sales of $8,052 million in the U.S., Lupin said citing IQVIA MAT March 2025 numbers. Rivaroxaban Tablets USP are indicated to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation and for treatment of deep vein thrombosis as well as pulmonary embolism, it said. Rivaroxaban Tablets are bioequivalent to Xarelto, which Jannsen said is a blood thinner to treat and help prevent blood clots related to certain conditions involving the heart and blood vessels.
