Sentences with phrase «of generic drug marketing»

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.

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.

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.

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.

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.»

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.

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).

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.

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.

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

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.

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.

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.

• 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).

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.

In the case of Apotex Inc. v. Eli Lily and Company, 2015 ONCA 305, Eli Lilly and Company and Eli Lilly Canada Inc. («Lilly») had used the process available under the regulatory scheme of the Patented Medicines (Notice of Compliance) Regulations, SOR / 93 -133, in order to keep Apotex's generic counterpart to Strattera (a drug used in the treatment of Attention Deficit Hyperactivity Disorder) off the market.

AstraZeneca's upset stomach: AstraZeneca delayed entry of generic competitors of its anti-ulcer drug and prevented parallel trade by abusing patents and marketing procedures, the European Court of Justice held in reducing AstraZeneca's fine slightly, to $ 52.5 million from $ 60 million.

Types of medications (including the names of generic and brand drugs) that have been linked to Stevens - Johnson Syndrome: • Anticonvulsants • Antibiotics • Nonsteroidal anti-inflammatory drugs (OTC and prescription) • Drugs with sulfa • Barbiturates • COX - 2 inhibitors • Ibuprofen • Acetaminophens • Allopurinol • Carbamazepine • Phenytoin • Bextra, which Pfizer removed from the market in 2005 because of the SJS risk it posed to users • Children's Advil or Motrin • Tylenol • Aldactone • Septra • Advil • Motrin • Avelox • Prilosec • Neurontin • Coreg • Feldene • Athrotec • Ceclor • Dilantin • Vioxx • Relafen • Celebrex • Levaquin • Depakote • Zantac • Tegretol • Provigil • Zithromax • Trileptal • Zyloprin • Clinoril • Phenytek Dangerous Drugs Severe drug reactions cause tens of thousands of patient deaths in this country each drugs) that have been linked to Stevens - Johnson Syndrome: • Anticonvulsants • Antibiotics • Nonsteroidal anti-inflammatory drugs (OTC and prescription) • Drugs with sulfa • Barbiturates • COX - 2 inhibitors • Ibuprofen • Acetaminophens • Allopurinol • Carbamazepine • Phenytoin • Bextra, which Pfizer removed from the market in 2005 because of the SJS risk it posed to users • Children's Advil or Motrin • Tylenol • Aldactone • Septra • Advil • Motrin • Avelox • Prilosec • Neurontin • Coreg • Feldene • Athrotec • Ceclor • Dilantin • Vioxx • Relafen • Celebrex • Levaquin • Depakote • Zantac • Tegretol • Provigil • Zithromax • Trileptal • Zyloprin • Clinoril • Phenytek Dangerous Drugs Severe drug reactions cause tens of thousands of patient deaths in this country each drugs (OTC and prescription) • Drugs with sulfa • Barbiturates • COX - 2 inhibitors • Ibuprofen • Acetaminophens • Allopurinol • Carbamazepine • Phenytoin • Bextra, which Pfizer removed from the market in 2005 because of the SJS risk it posed to users • Children's Advil or Motrin • Tylenol • Aldactone • Septra • Advil • Motrin • Avelox • Prilosec • Neurontin • Coreg • Feldene • Athrotec • Ceclor • Dilantin • Vioxx • Relafen • Celebrex • Levaquin • Depakote • Zantac • Tegretol • Provigil • Zithromax • Trileptal • Zyloprin • Clinoril • Phenytek Dangerous Drugs Severe drug reactions cause tens of thousands of patient deaths in this country each Drugs with sulfa • Barbiturates • COX - 2 inhibitors • Ibuprofen • Acetaminophens • Allopurinol • Carbamazepine • Phenytoin • Bextra, which Pfizer removed from the market in 2005 because of the SJS risk it posed to users • Children's Advil or Motrin • Tylenol • Aldactone • Septra • Advil • Motrin • Avelox • Prilosec • Neurontin • Coreg • Feldene • Athrotec • Ceclor • Dilantin • Vioxx • Relafen • Celebrex • Levaquin • Depakote • Zantac • Tegretol • Provigil • Zithromax • Trileptal • Zyloprin • Clinoril • Phenytek Dangerous Drugs Severe drug reactions cause tens of thousands of patient deaths in this country each Drugs Severe drug reactions cause tens of thousands of patient deaths in this country each year.

Mr. Simon also recently represented a generic brand drug company in an individual case alleging that the brand name manufacturer had filed false citizens petitions to delay the entry of the generic drug unto the market.

Teva filed an Abbreviated New Drug Application seeking market approval for a generic form of Helsinn's product, and Helsinn responded by filing an infringement action asserting all four patents against Teva.

Our pharmaceutical work puts us at the forefront of cutting edge issues, including preemption of medical device and prescription drug claims, the learned intermediary doctrine, comment k, market share liability, and brand name liability for generic use.

Instead, generic evidence purportedly showing that the manufacturer marketed the drug as having less of risk of tardive dyskinesia and other extrapyramidal symptoms than other drugs was not tied to the prescriber's decisions with plaintiff.

Through amendments to both the patent and the food and drug laws, the Act established several practices intended to provide brand - name firms with incentives to innovate while facilitating the marketing of generic pharmaceuticals.

Global Pharmacy Canada («Global»), which used the Internet to market and sell generic prescription drugs to Americans, marketed itself as a Canadian company and had a call centre which took customer orders and processed payments in Mississauga, Ontario, within the jurisdiction of the Ontario College of Pharmacists.

We have represented clients in numerous other congressional investigations and oversight hearings, including a major internet services company in an investigation of its practices abroad, a chemical manufacturer in an investigation of the safety of its products, an insurance company in a hearing on the federal long term care insurance program, a financial services company in an investigation of credit card terms, and drug companies in investigations concerning such matters as payments to doctors, marketing practices, generic approvals, drug importation, and drug safety.

Because this is a national health service, the government is now strongly supporting the generics market — during 2011, the share of generic drugs increased by over 40 % and the market is expected to reach over $ 60 billion by 2017.

«Traditional Big Pharma are becoming more and more combative in the development of new drugs, but their market share is being affected by the creation of generic and biosimilar drugs.

West End, District of Columbia About Blog Follow FiercePharma for pharma industry news on big pharma, FDA decisions, patents, pharmaceutical marketing, generic drugs, and other pharma news.

After graduating with degrees in psychology and social work — both of which Witt says are extremely beneficial in real estate — she worked as a marketing coordinator for generic drug maker Pharmascience, organizing activities for 40 sales reps.

As popular drug patents expire and a flood of generic medicines are expected to flood the market, the large firms are looking for better ways to earn revenue, such as expanding globally by pushing into emerging markets such as Brazil and China, or exploring more research and development of biopharma products (biological medicines, based on living tissues such as vaccines).