Latest news with #genericdrugs
Reuters
5 days ago
- Business
- Reuters
AstraZeneca agrees to $51 million settlement in Seroquel antitrust class action
May 30 (Reuters) - Drugmaker AstraZeneca has agreed to pay $50.9 million to settle a class action lawsuit in U.S. court accusing the company of scheming to delay a generic version of its schizophrenia drug Seroquel, causing companies to pay artificially higher prices. The plaintiffs, a group of drug purchasers including Smith Drug Co and KPH Healthcare Services, filed the preliminary settlement, opens new tab on Thursday in the U.S. District Court for the District of Delaware. The deal requires approval from U.S. District Judge Colm Connolly. The 2019 lawsuit alleged AstraZeneca schemed with Handa Pharmaceuticals to delay the marketing of a generic version of Seroquel XR, which is used to treat schizophrenia and bipolar disorder. Handa said it will pay $494,000 to settle the buyers' claims. A trial had been scheduled for May 5. AstraZeneca declined to comment. Handa and a lead attorney for the plaintiffs did not immediately respond to requests for comment. AstraZeneca and Handa denied any wrongdoing in agreeing to settle. They said the resolution avoids the expense and distraction of any further litigation. Worldwide annual sales of Seroquel once topped $5.3 billion. The class period covers business purchases from 2015 to 2017. In their settlement filing, the plaintiffs' attorneys called the amount an 'outstanding' result for the class of drug buyers. The plaintiffs' lawyers said they would seek up to 36% of the settlement fund for legal fees, or about $18.5 million. AstraZeneca in 2010 agreed to pay $520 million to the U.S. government to settle claims that the company illegally marketed and promoted Seroquel for unapproved uses. The company in 2011 paid $68.5 million to resolve U.S. states' claims over the alleged deceptive marketing of the drug. The case is In re: Seroquel XR (Extended Release Quetiapine Fumarate) Antitrust Litigation, U.S. District Court for the District of Delaware, No. 1:20-cv-01076-CFC. For direct purchasers: Jonathan Gerstein of Garwin Gerstein & Fisher For AstraZeneca: Benjamin Greenblum of Williams & Connolly For Handa: James Gallagher of Davis Malm & D'Agostine Read more: Hikma Pharma to pay $50 million to settle narcolepsy drug antitrust case 20 US states balk at Florida settlement with drugmaker Sandoz Mylan to pay $73.5 mln to settle drug wholesalers' EpiPen antitrust claims
Irish Times
23-05-2025
- Business
- Irish Times
Ireland U-turns to oppose EU pharma reforms after intense lobbying
Ireland has pivoted to oppose contentious European Union reforms aimed at broadening access to new drugs and medicines, following a blitz of lobbying from big pharmaceutical companies over recent months. The proposed reforms would cut back a current eight-year window pharma companies have to exclusively sell new drugs they produce, before cheaper generic competitors enter the market. Taoiseach Micheál Martin , Ministers and senior civil servants have all been on the receiving end of a significant push from the pharma sector, to get Ireland to adopt a pro-industry position in the EU debate. Irish health officials had been keen on the reforms improving access to new drugs. Allowing generic drugmakers into the market earlier would potentially result in cheaper prices for the Health Service Executive when buying medicines for public patients. READ MORE Speaking on Thursday, Minister for Enterprise Peter Burke confirmed the Government had shifted its stance. It now 'accepted' companies should retain the current eight years of market dominance over new drugs they developed, he said. This means Ireland has joined Denmark, Germany, Italy, Sweden and several other EU countries who support the pharma industry's position, heading into a vote in Brussels in the coming weeks. A compromise that would encourage companies to conduct more clinical trials in EU states, to earn back one lost year of protection from generic rivals, is the other option on the table in the vote. The original idea was to allow companies win back extra years of 'protection' over their research and data from clinical trials if they rolled out new drugs across the EU more quickly. [ US tariffs on pharmaceuticals risk shortages of lower-cost generic drugs Opens in new window ] Pharmaceutical firms staunchly oppose the proposals, which they claimed would make companies less likely to develop new medicines in Europe. Several pharma giants based in Ireland, such as Pfizer , Eli Lilly , Novo Nordisk and Johnson & Johnson (J&J), stepped up pressure on the Government to back the industry line, new logs of lobbying disclosures show. Much of the lobbying focused on getting the ear of Mr Martin and Department of the Taoiseach secretary general John Callinan. Oliver O'Connor, head of the Irish Pharmaceutical Healthcare Association (IPHA), argued that there were alternative ways to improve access to new medicines, in recent correspondence to several departments. The industry group chief wrote to Mr Martin directly, calling for the Government to take account of the major role the pharma sector played in Europe's economy, lobbying disclosures show. A lobbyist from J&J raised the matter with Robert Watt , Department of Health secretary general, on the margins of a think tank event in Dublin earlier this year. The pharma firm followed up in writing afterwards, making the case for 'protecting' the existing system. When the new Government was formed both Minister for Health Jennifer Carroll MacNeill and Mr Burke got letters of congratulations from the head of J&J's Irish operations, Michaela Hagenhofer. The US pharma company asked that support for companies' intellectual property rights 'be reflected' in Ireland's position at the European level, according to filings disclosing the lobbying. Danish pharma giant Novo Nordisk , which makes the blockbuster weight-loss drug Ozempic , also made representations. The head of Novo Nordisk's Irish operation, Nina Therese Hovland, lobbied Minister for Finance Paschal Donohoe at a dinner hosted by consulting firm EY . United States president Donald Trump 's threat of coming trade tariffs on pharmaceutical imports has put pressure on the Government to signal it supports the sector, which is a major employer and corporate tax contributor. Mr Martin met a delegation representing the Irish and European pharma industry in Government Buildings in mid-April. Lobbying logs show the meeting discussed trade tariffs and the EU reforms.
Reuters
20-05-2025
- Business
- Reuters
India's Gland Pharma posts quarterly profit fall, hit by sluggish U.S. sales
May 19 (Reuters) - India's Gland Pharma ( opens new tab, which make injectable versions of generic drugs, reported a 3.1% fall in fourth-quarter profit on Tuesday, weighed down by weaker sales in the U.S., a key region for the company. The company reported a consolidated net profit of 1.87 billion rupees ($21.9 million) for the quarter ended March 31, compared with 1.92 billion rupees in the year-ago quarter. Revenue from operations slipped 7.3% to 14.25 billion rupees. Sales from U.S. business, which accounts for 54% of the total, fell 10%. For further results highlights, click (Full Story) KEY CONTEXT Production setbacks at Cenexi's facilities in Paris and Belgium for the past two quarters have been weighing on the company's earnings. Most of India's generic drugmakers derive a significant share of revenue from the United States, where lower drug prices due to stiff competition have been weighing on earnings. Rivals Sun Pharma ( opens new tab and Cipla ( opens new tab and Dr Reddy's ( opens new tab beat fourth-quarter profit estimates. PEER COMPARISON * Mean of analysts' ratings standardised to a scale of Strong Buy, Buy, Hold, Sell, and Strong Sell ** Ratio of the stock's last close to analysts' mean price target; a ratio above 1 means the stock is trading above the PT JANUARY TO MARCH STOCK PERFORMANCE -- All data from LSEG -- $1 = 85.5650 Indian rupees ($1 = Indian rupees)
Yahoo
16-05-2025
- Business
- Yahoo
United States Generic Drugs Market Analysis Report 2025-2033: Patent Expiry of Blockbuster Drugs, Generics and Innovator Drugs Price Differential, Dispensing Incentives, Reimbursement and Co-payments
The market in the United States is primarily driven by the product's ease of availability and affordability, which is supported by the growing number of expired patents. In addition, the aging population in the United States necessitates a greater volume of medications, and the expiration of patents for several blockbuster drugs creates growth opportunities for generic manufacturers. Additionally, the market is catalyzed by the rising cost of healthcare, including prescription medications, which forces payers and healthcare providers to encourage the use of generic drugs in order to control costs. U.S. Generic Drugs Market Dublin, May 16, 2025 (GLOBE NEWSWIRE) -- The "United States Generic Drugs Market Size and Share Analysis - Growth Trends and Forecast Report 2025-2033" report has been added to States Generic Drugs Market is expected to reach US$ 131.80 billion by 2033 from US$ 95.87 billion in 2024, with a CAGR of 3.60% from 2025 to 2033In terms of dosage, potency, safety, efficacy, mode of administration, and intended purpose, a generic medication is a pharmaceutical product that is bioequivalent to a brand-name medication. It is manufactured and sold following the expiration of the original brand-name drug's patent protection. These drugs go through extensive testing by regulatory bodies to guarantee their efficacy, safety, and quality, and they contain the same active components as their name-brand equivalents. A larger population may now afford and receive healthcare due to the many benefits of generic medications, which include reduced costs, improved accessibility, and more affordability. They are essential in boosting competition in the pharmaceutical industry, offering affordable substitutes for name-brand medications, and improving the general effectiveness of American healthcare Drivers for the Generic Drugs Market The region's growing drug shortageThe region's drug market is growing stronger as a result of the growing shortage. Brand-name medication shortages can be caused by a number of things, including as problems with manufacturing, difficulties with regulations, interruptions in the supply chain, and rising demand. Generic alternatives may become more popular as a result of these shortages. It may be difficult for pharmacies and healthcare professionals to keep a steady supply of name-brand drugs during a drug shortage. As a result, they turn to generic medications as a substitute to ensure continuity of patient care. Generic medications offer a feasible alternative during these shortages as they are generally widely available, produced by several producers, and competitively order to lessen the effect of medication shortages on patient treatment programs, medical professionals may also proactively prescribe generic medications as substitutes. Hospitals and healthcare systems may occasionally put policies in place to encourage the use of generic medications during shortages in order to maximize resource allocation and reduce patient care interruptions. Furthermore, using generic medications during drug shortages helps to solve short-term supply issues and eventually supports the expansion of the generic medicine market. This gives patients, payers, and healthcare professionals a chance to see the benefits and dependability of generic drugs, which could boost use and expand the market for them after the shortage is need for managing chronic illnessesThe industry is being positively impacted by the rising need for managing chronic diseases. Chronic illnesses that necessitate long-term medication use include diabetes, cardiovascular diseases, and respiratory disorders. Cost-effective medication options are essential as the population ages and the prevalence of chronic diseases rises. Furthermore, generic medications offer a cheap alternative for addressing chronic conditions. They guarantee comparable therapeutic effects at a fraction of the price because they contain the same active ingredients as their name-brand equivalents. This makes them highly attractive to patients, healthcare providers, and most common type of heart illness is coronary heart disease, according to a May 2023 report released by the Centers for illness Control and Prevention. Globally, one in twenty persons aged 20 and above, or around 5% of the population, suffers from coronary artery disease (CAD).Approximately 850,000 Americans suffer a heart attack each year, according to the same source. Of these, more than 200,000 people have already experienced a heart attack, and 605,000 have experienced their first. Since the need for affordable medications used during treatment is a major factor in the growth of the generic drugs market, this offers the US generic drug market a sizable market because generic medications have been shown to be safe and effective, medical professionals frequently give them priority when managing chronic illnesses. To increase adherence and cut expenses, they might recommend generic drugs as a first-line therapy choice or urge patients to move from name-brand drugs to their generic counterparts. Furthermore, payers - such as government programs and insurance companies - are aware of the potential cost savings associated with generic medications in the treatment of chronic illnesses. In order to make generic medications more accessible and affordable for patients, they might provide preferential coverage or reduced co-pays. Additionally, formulary management programs may include generics as preferred options, further driving their of patent cliffsThe term "patent cliff" describes the situation where patents on popular name-brand medications expire, allowing generic competitors to enter the market. Generic manufacturers are legally permitted to manufacture and market their medicine copies after a patent expires, frequently at much reduced costs. Additionally, patent cliffs are providing generic medicine producers with profitable chances to enter the market and provide less expensive substitutes for name-brand medications. Since there is more competition when patents expire, the market for generic medications is expanding. The cost of drugs is reduced and pricing transparency is encouraged by this greater competition, which benefits both patients and healthcare in order to find ways to cut costs and encourage the use of generics, pharmaceutical corporations and healthcare providers keep a careful eye on patent expirations. To benefit from the cost savings, they might aggressively move patients to generic alternatives. Furthermore, by establishing a competitive environment and stimulating innovation among generic manufacturers, patent cliffs in the pharmaceutical sector increase access to more reasonably priced pharmaceuticals and promote market expansion for generic in the United States Generic Drugs Market Regulatory hurdlesOne major obstacle in the US generic medication business is regulatory barriers. When it comes to sophisticated medications like biologics or biosimilars, the FDA approval procedure for generics can be drawn out. The Abbreviated New Drug Application (ANDA) process is complicated to navigate, involving a lot of paperwork and strict adherence to rules. Furthermore, brand-name companies' ""pay-for-delay"" agreements and patent litigation can postpone the entry of generics, decreasing competition and raising consumer costs. These regulatory hurdles often slow down market entry for VolatilityDue to variables like abrupt increases in demand, supply shortages, and market consolidation, price volatility is a significant problem in the generic medication industry in the United States. Generic prices might rise significantly due to unforeseen circumstances like production problems or market monopolies, which puts a burden on patients and healthcare systems. Furthermore, manufacturers' intense competition causes prices to drop quickly, which affects sustainability and profit margins. The market is unstable because to this volatility, which makes pricing tactics more difficult for insurers and producers States Generic Drugs Overview by StatesIn the United States, the need for generic medications varies by state, with major markets like California, Texas, and New York experiencing more demand because of their larger populations. Due to cost reductions and competition, states with strong healthcare systems and more affordable drug programs - like Florida and Pennsylvania - also have high rates of generic medicine use. Company Analysis: Overview, Key Persons, Sales Analysis, Recent Developments Teva Pharmaceuticals Aurobindo Pharma Sun Pharmaceuticals Abbott Laboratories Inc Lupin Pharmaceuticals, Inc Viatris Sandoz Dr. Reddy's Laboratories Key Attributes: Report Attribute Details No. of Pages 200 Forecast Period 2024 - 2033 Estimated Market Value (USD) in 2024 $95.87 Billion Forecasted Market Value (USD) by 2033 $131.8 Billion Compound Annual Growth Rate 3.6% Regions Covered United States Key Topics Covered: 1. US Generic Drug Market - Introduction1.1 What are Generic Drugs?1.2 Unbranded and Branded Generics1.3 Authorized Generics1.4 Commoditized and Specialty Generics2. Why is the US Generic Drug Market So Lucrative2.1 Patent Expiry of Blockbuster Drugs2.2 Significant Price Differential between Generics and Innovator Drugs2.3 Savings for the Government and Third-Party Payers2.4 Incentives for Dispensing and Prescribing Generic Drugs2.5 Reimbursement and Lower Co-payments3. Research & Methodology4. Executive Summary5. Market Dynamics5.1 Growth Drivers5.2 Challenges6. United States Generic Drugs Market7. Market Share Analysis7.1 By Type7.2 By Therapeutic Area7.3 By Drug Delivery7.4 By Distribution Channel7.5 By Age Group7.6 By Payment Type7.7 By State8. Type8.1 Branded Generics8.2 Unbranded Generics9. Therapeutic Area9.1 Heart Disease9.2 Mental Health9.3 Diabetes9.4 Epilepsy9.5 Cancers9.6 Allergies & Asthama9.7 Chronic Obstructive Pulmonary Diesase9.8 Alzheimer's Disease9.9 HIV/AIDS9.10 Crohn's colitis10. Drug Delivery10.1 Oral10.2 Injectables10.3 Dermal/Topical10.4 Inhalers11. Distribution Channel11.1 Specialty Pharmacy11.2 Retail Pharmacy11.3 Hospital Pharmacy11.4 Online Pharmacy12. Age Group12.1 Children (0-19 years)12.2 Young Adults (20-39 years)12.3 Adults (40-64 years)12.4 Seniors (Above 65 years)13. Payment Type13.1 Cash13.2 Commercial13.3 Medicaid13.4 Medicare D14. State14.1 California14.2 Texas14.3 New York14.4 Florida14.5 Pennsylvania14.6 Ohio14.7 Illinios14.8 North Carolina14.9 Georgia14.10 Michigan14.11 Others15. Porter's Five Forces Analysis15.1 Bargaining Power of Buyers15.2 Bargaining Power of Suppliers15.3 Degree of Rivalry15.4 Threat of New Entrants15.5 Threat of Substitutes16. SWOT Analysis16.1 Strengths16.2 Weaknesses16.3 Opportunities16.4 Threats17. Regulations in the US Generic Drug Industry17.1 Overview of Pharmaceutical Regulations17.2 Drug Applications17.3 Patents and Market Exclusivity17.4 Regulatory Requirements for Generic Drugs17.5 The Hatch-Waxman Act17.6 Certifications17.7 Other Important Considerations18. Key Players Analysis For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment U.S. Generic Drugs Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Times of Oman
16-05-2025
- Business
- Times of Oman
Generic pharma companies unlikely to be impacted by Trump's order to cut Rx drug prices: Report
New Delhi: Generic drug companies in India are not expected to be affected by US President Donald Trump's new order to bring the prices for prescription (Rx) drugs in line with other developed nations, according to a report by HDFC Securities. The report stated that the order aims to reduce the cost of prescription medicines in the US by matching them with the prices paid by other developed countries. It said, "In our view, the generic companies are unlikely to have any impact". This executive order introduces the "Most-Favoured-Nation (MFN)" price model. Under this model, the US will not pay more for drugs than the lowest price paid by other developed nations. Earlier, this pricing model only applied to Medicare in 2020. Now, it has been expanded to cover both Medicare and Medicaid. The move follows Trump's earlier statement that the government aims to cut the prices of prescription drugs by 30-80 per cent. This announcement came after the US Department of Health and Human Services (HHS) published a study in February 2024, which showed that drug prices in the US were significantly higher than those in other countries. According to the report, the average drug price in the US was 277 per cent of the international average. For branded drugs, the difference was even higher, US prices were 422 per cent more than other countries, and the top 60 brands were 504 per cent costlier. In contrast, generic drug prices in the US were only 67 per cent of the prices in other developed countries. Despite this, many details of the policy remain unclear, the report noted that it is not yet known which drugs, companies, or countries will be covered under the MFN model. Officials are expected to inform pharmaceutical companies about the target MFN prices within the next 30 days. The executive order also plans to bypass pharmacy benefit managers (PBMs) by allowing American patients to purchase medicines directly from manufacturers at MFN prices. Other provisions include heavy discounts for low-income patients on lifesaving drugs, importation programs, and steps to boost the availability of generic and biosimilar medicines. However, the report also mentioned that the executive order is likely to face legal hurdles. A similar MFN rule introduced in 2020-21 was blocked by courts. Still, the report believes that generic drug companies are unlikely to be impacted by this policy.
