Sentences with phrase «generic drug markets»

This may be because of more intense therapy for chronic illness, improved access to medications due to Medicare Part D, and the growth of the generic drug market.

In line with the introduction of the patent linkage system in the Pharmaceutical Affairs Act, the amended Patent Act's provision will be added to clarify the basis for patentees of new drugs to bring an infringement lawsuit to court during the process of generic drug marketing approval.

Not exact matches

For one thing, «There are a lot of good drugs on the market for heart disease right now that come in generic form,» says Neil Lesser, a principal at Deloitte who specializes in the life sciences, in an interview with Fortune.

Nonetheless, Pessina said it remains a «challenging market for pharmacies,» with increasing margin pressure on generic drugs.

The FDA is trying to get more cheap generic drugs on the market.

He suggested coming up with a faster approval timeline for generics coming to market to take on drugs with high prices.

The companies have begun to market their «biosimilar» (a generic version of expensive biologic drugs) of Remicade — a copycat of J&J's best - selling rheumatoid arthritis and immunology treatment (which garnered more than $ 5 billion in U.S. sales last year) and was approved by the Food and Drug Administration (FDA) in April — at a striking 35 % discount to its list price.

Often it turns out that the price increases by Valeant and Turing that have provoked the most criticism have been on drugs that are off - patent — meaning generic competitors are free to enter the market, typically bringing the price that most people pay for the drugs way down.

The company couldn't say whether its drug price increases have typically occurred before or after a generic version launches, but said that once a generic is available, it would expect to lose so much market share that it «needs to increase the price to keep production of the drug viable.»

Here's how it went: Shortly before 9 a.m. New York time (and before U.S. markets opened), generic drug giant Teva Pharmaceutical (TEVA) confirmed its unwelcome bid to acquire rival Mylan (MYL) for $ 40 billion.

According to the GAO report, 71 percent of all generic injectable cancer drugs sold in 2008 were produced by just three manufacturers, while 91 percent of the market share of injectable nutrients and supplements was held by just three pharmaceutical firms.

Still, he's taken on market inefficiencies, called for expanding access to biosimilars, is approving generics at a record pace and trying to bring down drug prices.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SDrug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the Sdrug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

Since biosimilars are so new to the U.S. market (there have been just five total approved here since 2015), it's been hard to gauge whether or not they can make a formidable dent in high drug prices by offering generic alternatives to branded treatments.

FILE PHOTO: A building belonging to generic drug producer Teva, Israel's largest company with a market value of about $ 57 billion, is seen in Jerusalem March 23, 2010.

Deals between pharmaceutical corporations and their generic drug competitors, which government officials say keep cheaper forms of medicine off the market, can sometimes be illegal and therefore can be challenged in court, the Supreme Court said Monday...

WASHINGTON (AP)-- The Supreme Court on Wednesday considered a drug company's fight to keep a generic version of its biotech drug off the market for an additional six months that would mean billions more in sales and higher costs to the public.

Teva beats first - quarter expectations but still has the same old problems Copaxone's market share and new generic launches helped Teva to forecast - beating profit and revenue but problems persistTeva had to make pricing concessions on its flagship multiple sclerosis drug Copaxone, and now expects a delay in approval of a key migraine drug, fremanezumab.

An Abbreviated New Drug Submission (ANDS) must be approved by Health Canada, the country's federal department in charge of national health care, under Canada's Food and Drug regulations before the generic drug can be marketed in the counDrug Submission (ANDS) must be approved by Health Canada, the country's federal department in charge of national health care, under Canada's Food and Drug regulations before the generic drug can be marketed in the counDrug regulations before the generic drug can be marketed in the coundrug can be marketed in the country.

Generic drugs are poised to steal market share as patent protections on a number of branded drugs expire.

Zytiga's future is murkier than the other two drugs because Zytiga's patent protection is expiring later this year and that may lead to the launch of generic drugs that begin to chip away at its market share.

In May generic drug company Actavis Inc. agreed to buy Warner Chilcott PLC for $ 8.5 billion in stock, creating the third - biggest specialty pharmaceutical company in the U.S. market.

Before any company can make and market even a generic pharmaceutical drug in the United States, it must be granted a special authorization by the FDA.

The worry is revenue from Humira will drop off a cliff as generic drugs enter the market.

Roche's drug, Valium, has been available on the market now for regarding forty five many years, and of course is currently in its generic variety, Diazepam.

The lawsuit takes primary aim against pharmaceutical companies that make promote, market and distribute opioid - based drugs such as OxyContin and Percocet and generics such as oxycodone and hydrocodone.

Decreased market competition causes generic drug prices to rise significantly, according to an article published in Annals of Internal Medicine.

In addition, researchers found low market competition levels had a more pronounced correlation with drug prices in lower - priced generic drugs compared with their higher - priced counterparts.

After controlling for other factors, a generic drug in the highest marketing competition group was expected to see a decrease of 32 percent in price over the study period, while a generic drug in the lowest market competition was expected to see a price increase of 47 percent over the same period.

Increasingly, international donors are withdrawing support from these countries, and drug makers such as Gilead are likely to see them as untapped markets for their products and thus exclude them from generic licensing deals.

There is no indication the generic ibuprofen gelatin capsules hurt anyone, but their case shows how the FDA left a drug on the market for months without confirmation that the drug was equivalent to the name brand.

If they are on the market without generic versions to challenge them then companies can maintain monopoly prices, and in doing so harm consumers by preventing or delaying access to cheaper drugs.»

Dr Bokhari said: «The drug companies argue that they have a right to protect their intellectual property and that these agreements benefit consumers by enabling generic versions to come onto the market sooner than they would normally have, for example if licensed entry has been allowed at a later date but before the patent expires.

Controversial deals that delay generic versions of drugs coming onto the market can lead to consumers paying significantly more for some treatments, according to new research by an academic from the University of East Anglia.

Meanwhile, on the regulatory front, Dr. Scott Gottlieb, the new commissioner of the Food and Drug Administration, has spoken extensively about creating provisions to speed generic drugs to the market.

But the growth of e-commerce has flooded the market with a wide range of both brand name and generic drugs.

The study included 35 patients, adults with epilepsy who currently take lamotrigine, and looked at long - term dosing using two currently on - market epileptic generic drugs.

Their findings offer a glimpse into what could be happening with generic competition in this specialty drug market.

(TOM GRILL / CORBIS) In 2005 the FDA approved Rozerem (generic name ramelteon), a prescription sleep aid different from any existing drug on the market.

The worry is revenue from Humira will drop off a cliff as generic drugs enter the market.

A generic drug maker who wishes to obtain consent from Health Canada to market a drug based on the same active ingredient (called a Notice of Compliance or... [more]

The Patent Act and the PM (NOC) Regulations seek to balance «effective patent enforcement» over new and innovative drugs with the «timely market entry» of lower priced generic versions once the patents have expired.

Bladder Cancer is A Serious Side Effect for Many Taking Diabetes Drug Actos, Drug Injury Lawyers Blog, November 13, 2012 Whether generic or brand, medications that are dangerous, defective in design, improperly marketed, or come with poor instructions and inadequate warnings can cause serious injuries and even death to consumers.

• longer periods of protection of data exclusivity protection for brand name drugs to keep generics off the market;

Currently, Canada is the only country that allows brand name pharmaceutical companies to sue generic pharmaceutical companies multiple times on the same patents, adding to the costs and risks of bringing generic drug competition to the Canadian market.

Sandoz and other generic drug companies filed Abbreviated New Drug Applications seeking approval to market a generic form of the ddrug companies filed Abbreviated New Drug Applications seeking approval to market a generic form of the dDrug Applications seeking approval to market a generic form of the drugdrug.

Pay - for - delay («PFD») agreements are agreements that are intended to delay the market entry of generic manufacturers with generic drugs in exchange for payments made by original pharmaceutical producers (i.e., holders of patents for an original branded drug).

The TPP requires parties to provide a «pre-approval» procedure for patented pharmaceuticals, with two options: 1) provide notice to a patent holder if a competitor applies to market an identical or similar drug during the patent term, along with an opportunity to seek a legal remedy such as a preliminary injunction before the generic drug is marketed; or 2) preclude marketing approval for a drug that is subject to another person's patent, unless the patent holder or original drug manufacturer consents.

In practice, it is usually the first approved indication that is free of exclusivity protection earlier in time and generics, while submitting drug applications for an early market entry, carve out the subsequent indications from the label to avoid potential infringement of patents which may cover the new approved indications.

This is so because any undertaking active in the pharmaceutical sector is familiar with the fact that preparation for the production of generic versions of drugs commences many years before the expiry of an original patent, and that the expiry itself triggers an intense race in order to be the first to enter the market.