Many large retailers, such as Target, Walmart, and Kmart, offer hundreds of types of
generic drugs at substantial discounts.
Merritt cited a backlog among approval for
generic drugs at the FDA as one of the reasons that many drugs don't face generic competition just yet.
Prices for roughly 300
generic drugs at least doubled from 2010 to 2015.
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.
Rajiv Malik, president and executive director
at EpiPen maker Mylan (essentially the company's number two exec), has been named in a wide - ranging civil suit alleging
drug price collusion by numerous prominent
generic drug makers.
These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from
generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or
at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website
at www.sec.gov.
Plus, a handful of companies will typically all get approved to make a
generic at once, which ideally creates competition in the marketplace and can sometimes result in even lower prices for those
drugs.
Daiichi Sankyo's press release comes in the wake not only of Ranbaxy's highly unusual criminal guilty plea and $ 500 million in fines and penalties — the largest ever against a
generic -
drug maker — but also a lengthy Fortune article that exposed for the first time the depth and extent of the fraud charges leveled
at the company and the knowledge of senior company executives.
The epic inside story of long - term criminal fraud
at Ranbaxy, the Indian
drug company that makes
generic Lipitor for millions of Americans.
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.
While the
drug maker has responded to the massive backlash over its extravagant price increase on the device by boosting its patient assistance programs and introducing an authorized
generic EpiPen version
at half the cost, CVS» topline price will still be significantly cheaper.
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 S
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 S
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 SEC).
After graduating from the University of Calcutta in 1982, Dilip Shanghvi started working
at his father's wholesale
generic -
drugs business, where he saw an opportunity to manufacture Lithosun, a
drug that treated manic - depressive disorders and was unavailable in much of eastern India.
Provincial governments, strapped for cash and facing ballooning deficits, have been hacking away
at the prices they pay for
generic drugs.
Akorn — German drugmaker Fresenius pulled out its $ 4.75 billion deal to buy the U.S.
generic drugmaker, saying it had found «material breaches» of Food and
Drug Administration data integrity requirements
at Akorn.
Fresenius (FMS) pulled out its $ 4.75 billion deal to buy U.S.
generic drug - maker Akorn (AKRX), saying it had found «material breaches» of FDA data integrity requirements
at Akorn, which disputes those claims.
Israel - based Teva, the world's largest maker of
generic drugs, has been looking
at divestures to help pare its $ 35 billion debt pile.
Once a
drug loses its patents,
generic drug manufacturers start selling copycat versions
at substantially lower prices.
Stada's owners are also mulling bids for the
generic drug business being sold by Sanofi, the sources said, and might favor this combination over Merck as
generic drugs are typically valued
at a cheaper multiple.
The tough news keeps coming
at the
generic drug company, which announced last week it was considering putting itself up for sale.
The solanezumab disappointment comes
at a time when Lilly is facing
generic competition on several high - profile
drugs, including erectile dysfunction medicine Cialis, ADHD
drug Strattera and cardiovascular treatment Effient.
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.
Court documents made public late on Tuesday show that Fresenius (NYSE: FMS) dropped its acquisition of Akorn after uncovering evidence that the
generic drug developer submitted fraudulent data to the U.S. Food and Drug Administration for at least six different drugs dating back to 2
drug developer submitted fraudulent data to the U.S. Food and
Drug Administration for at least six different drugs dating back to 2
Drug Administration for
at least six different
drugs dating back to 2012.
As long as that strategy continues to control the decline in Remicade's sales, then growth from these
drugs should offset any drop —
at least until J&J has to deal with a
generic Zytiga.
The U.S. Food and
Drug Administration's approval of Mylan N.V. (NASDAQ: MYL)'s
generic version of Copaxone for the treatment of relapsing multiple sclerosis should be seen as a «clear negative» for Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)'s Glatopa franchise, analysts
at Baird said.
** German healthcare group Fresenius SE said it had decided to pull out of its planned acquisition of Akorn after it found data integrity breaches
at the U.S.
generic drug maker.
BERLIN German healthcare group Fresenius SE said it had decided to pull out of its planned acquisition of Akorn after it found data integrity breaches
at the U.S.
generic drug maker.
This prevented developing countries from producing
generic versions of patented
drugs, notably treatments for HIV / AIDS and malaria, which they maintained were being sold
at unfair prices.
They estimate that
generic -
drug manufacturers should be able to produce the pills
at $ 100 — 250 for a 12 - week course.
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.
For example, sofosbuvir's manufacturer, Gilead Sciences Inc. of Foster City, California, sells the
drug to Egypt
at a discount and allows
generic manufacturers in India to produce and sell in 91 poorer countries.
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.
The
generic risperidone products will have the same safety warnings as Risperdal, including a boxed warning, cautioning that older patients with dementia - related psychosis treated with atypical anti-psychotic
drugs are
at increased risk of death, as compared with those taking placebo.
Oseltamivir, a
generic form of the oral antiviral
drug Tamiflu, received FDA approval
at the end of last summer, and both it and an inhaled antiviral, zanamivir (aka Relenza) are available by prescription this season.
We don't very often see [that] the
generic drug that's available
at your drugstore anyways might have some use for cancer.»
That collection belonged to Marvin Schein, a manufacturer and distributor of
generic drugs and medical products from Long Island who had spent years quietly buying paintings, porcelains and French furniture, many of them
at auction.
The firm undertook an analysis of data in the FDA's Adverse Event Reporting System related to the stomach disorder
drug, and «identified
at least 106 cases of tardive dyskinesia or other movement disorders reported among users of Reglan or its
generic version, metoclopramide.»
Represented Braintree Laboratories
at the Federal Circuit to reverse a district court's grant of summary judgment of noninfringement for Breckenridge Pharmaceutical, following a patent dispute concerning Breckenridge's planned
generic version of Braintree's SUPREP laxative
drug.
The Jean Coutu Group were facing several challenges
at the time including
drug distribution reform and the purchase of a Quebec
generic drug manufacturer.
While pharmaceutical giant Pfizer is trying to get the Supreme Court of Canada to take a second look
at its recent judgment voiding its patent on Viagra, it's trying to use the same decision to quash a case in the Federal Court involving another
generic drug maker.
At issue is whether the Supreme Court should reinforce its 2011 ruling that protected
generic drug manufacturers from state products liability claims accusing them of not warning about possibly dangerous side effects.
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.
Whether or not it was envisioned
at the time, the use of
generic drugs in the US has seen a tremendous increase since the enactment of the Act.
Pfizer sells about 600
generic medicines, including
at least 40 that it made a deal for this week that it will sell in the United States; and Teva now reportedly gets about 30 % of its revenue from branded
drugs.
[10] Prior to 2006, the price
at which manufacturers could apply to list
generic drugs in the Formulary was capped by regulations under the Actsat effectively 63 % of the price of the brand - name
drug.
«Any recognition of an outlier theory of liability permitting a
generic drug consumer to bring an action against the brand manufacturer for an injury allegedly arising from the use of the
generic drug would be plainly
at odds with this public policy.»
If your employees take prescription
drugs, check the cost of both
generic and brand
drugs at the pharmacy.
Optional prescription
drug benefits up to $ 5,000 per insured per policy period (100 % after a $ 10 copay for
generics, name brand prescriptions require a $ 25 copay and injectibles are covered
at 70 %).
Or what about which prescription
drugs your plan covers, and which are
generic - or not covered
at all?