The judgment of the CJEU affirming the General Court's decision in its entirety forebodes misfortune at best and disaster at worst
for generic companies.
One factor that could discourage that option is that Daraprim's distribution is now tightly controlled, making it harder
for generic companies to get the samples they need for the required testing.
Not exact matches
The
company also fought back with a counterclaim seeking to have the «froyo» trademark expunged, arguing the term is
generic in the same way that «shake» is now short
for milkshake.
The Hong Kong - listed
company has two blockbuster drugs on its roster — anlotinib
for lung cancer and tenofovir
for hepatitis B — and a few blockbuster
generics aiming
for approval before 2021.
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.
The PR fiasco forced the
company to buttress its own patient assistance and rebate programs
for the EpiPen and to introduce an authorized
generic version of the device at half the price.
That freed up other
companies to start making
generic pods that would still work in Keurig - brand coffee brewers — and those clones typically sold
for 15 - 25 % less than the brand - name pods sold by Keurig directly.
The main reason
for this move towards
generic - ism is technological — it's relatively easy nowadays
for one
company to duplicate another's services, especially when that
company is sitting on piles of money.
For the full year, the
company reiterated its view that EPS would be flat to down 3 percent in constant currencies, if
generic copies of Advair hit the U.S market by mid-year.
«Shoppers tends to be a Top Five
company, but last year was a low point
for them with the fight
for generic drugs,» says Susan Quinn - Mullins, a senior adviser to the Research Institute.
The reason there's no
generic Viagra yet is because Pfizer, the
company that makes it, holds two patents
for the drug: the first
for Viagra's composition — which expired in 2012 — and the second
for what's called a «method of treatment,» meaning how the drug is used.
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.
Congress seems to think that a trove of documents including anything prepared
for the
company's board having to do with the EpiPen, Mylan's tax rate, profits connected to the EpiPen, manufacturer contracts related to the EpiPen, anything related to EpiPen pricing in the Netherlands, and anything having to do with a
generic EpiPen could help answer that question.
PARIS, April 17 - French healthcare group Sanofi is in exclusive talks to sell its Zentiva European
generics drugs arm to private equity firm Advent International
for 1.9 billion euros, the
companies said on Tuesday.
Revenue growth has slowed as many
companies sink more resources into developing the next blockbuster drug; what's more, the «patent cliff»
for the last round of megabillion - dollar drugs — when
generics firms typically see a sales spurt — happened a few years ago.
Given its areas of specialization, Gilead wouldn't benefit as much from consolidation as, say, a
generic - drug
company would, but it still faces pricing pressure: To appease Medicaid and other insurers, Gilead is already steeply discounting its hep - C drugs, which can cost more than $ 80,000
for a 12 - week course.
Teva Pharmaceuticals has proposed buying rival Mylan
for $ 40 billion in cash and stock, as the Israel - based drugmaker looks to gain dominance among
generic pharmaceutical
companies.
The
generic pharmaceutical
company came into the spotlight in August 2016
for raising the price of the EpiPen to $ 608.61 from $ 93.88 over the past decade.
Pfizer has reached settlements with
companies like Teva, which are producing their own
generic Viagra versions, to allow
for those treatments to enter the market.
In Africa,
for example, some smaller pharmaceutical
companies have profitably sold
generic drugs and commercially developed local products.
Jazz said in a filing that it did so in response to the overall takeover environment
for pharma
companies and in light of a patent litigation settlement that allows Hikma Pharmaceuticals to sell a
generic version of Xyrem with Jazz receiving royalty payments on those sales.
That's an even rarer feat
for a
generic drug maker such as Mylan, which makes most of its revenue not on brand - name drugs, but on cheaper, equivalent versions of other
companies» branded medications.
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.
In the letter, the antitrust bureau chief
for New York Attorney General Eric Schneiderman asked Shkreli to contact the office «immediately» to respond to concerns that the
company's sales practices were intended to deter
generic pharmaceutical firms from creating alternatives to the drug.
«Our proposal would provide Teva stockholders with very attractive strategic and financial benefits and Mylan stockholders with a substantial premium and immediate value
for their shares, as well as the opportunity to participate in the significant upside potential of the combined
company — one that would transform the global
generics space and leverage it to hold a unique leadership position in the pharmaceutical industry.
Mylan has been among the fastest growing
companies in the Japan
generics market
for the last three years.
The FDA's action cuts off a vital supply line
for the
company, given that the plant reportedly makes about 70 % of the ingredients that Ranbaxy uses to make its U.S. drugs, including the
generic version of Lipitor taken by millions of Americans.
The tough news keeps coming at the
generic drug
company, which announced last week it was considering putting itself up
for sale.
DOJ investigates more than a dozen
generic drug
companies over alleged price fixation
for two - dozen drugs, based on two year long investigation
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.
The
company told investors on its Q1 conference call, however, that it doesn't anticipate any
generic Zytiga launches this year, and as a result it expects Zytiga's revenue tailwinds to continue supporting its full - year revenue outlook
for between $ 79.5 billion to $ 80.3 billion, which would be up 4 % to 5 % from 2017 on an ex-currency basis.
A federal judge in Delaware on Friday struck down key patents held by Acorda related to Ampyra, opening the doors
for generic versions of the drug by
companies including Mylan Inc (MYL.O) and Roxane Laboratories Inc..
The AIDS pandemic in Africa may be a
generic social issue
for a U.S. retailer like Home Depot, a value chain impact
for a pharmaceutical
company like GlaxoSmithKline, and a competitive context issue
for a mining
company like Anglo American that depends on local labor in Africa
for its operations.
Carbon emissions may be a
generic social issue
for a financial services firm like Bank of America, a negative value chain impact
for a transportation - based
company like UPS, or both a value chain impact and a competitive context issue
for a car manufacturer like Toyota.
Botnets are hacking accounts on message boards and setting up Twitter accounts, all the time cultivating a reputation with real users by,
for example, posting
generic comments about a
company.
Five years later, Gilead became the first pharmaceutical
company to sign an agreement with the newly formed Medicines Patent Pool — an organisation formed to coordinate the licensing of patent - protected medicines so that they can be produced in
generic form
for low income countries.
Instead of going through his slides one last time, he had been stuck in Human Resources filling out a
generic application form used
for all the
company's new hires, from warehouse workers to scientists.
GSK says it also plans to take a more «graduated» approach to filing and enforcing patents
for other medicines to encourage
generic drug
companies to make and supply GSK products now available mainly in developed countries.
It was only later on that summer that we learned that Rampant Films was really a front
for Premise Media, a Canadian filmmaking
company and that, in fact, the film was not called Crossroads at all, it was to be called Expelled, and it was an antiscience and a pro-intelligent design movie rather than being, kind of, a
generic creationism and evolution movie, so I mean, was just flabbergasted.
By planting this paper in the medical literature, the
company was preparing
for the approval process by highlighting in the medical literature the deficiencies of the best - selling
generic that the new drug would compete with.
But as its patent expires on November 30 and its first
generic competitor takes the stage, Lipitor is also a painful reminder of the challenge that such «patent cliffs» pose
for the big drug
companies, including Lipitor's developer Pfizer, based in New York.
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.
* Eliminate «pay -
for - delay» strategies in which a pharmaceutical
company with a brand name drug shares profits on that drug with a
generic drug manufacturer
for the remainder of a patent period, effectively eliminating a patent challenge and competition.
These
companies offer medications at several different price points, but even low - cost,
generic options (which run about $ 15 a month) can be prohibitive
for low - income women, says Kyl Myers, PhD, a sociologist and research associate in the University of Utah's department of obstetrics and gynecology.
Attempting to determine dosage amounts of a drug according to the
generic recommendation that «this will work
for everybody» from a
company or business that is interested more in making a sale than in the health of the population is counterproductive to the initial impetus behind taking the medication in the first place.
In spite of what other
companies may want the consumers to believe, there is no static,
generic dosing
for medication like this.
Only Juice Beauty took the time to write a personal email that recommended specific products that are safe
for pregnant women; the other
companies merely sent
generic form responses.
biggest issue with the Wii U is their ignorance of North America, their poor online experience and slow game turnover rate
generic 3rd party support is almost dead on Wii U, so its good to see Nintendo going to other
companies to make some exclusive titles
for them (hyrule warriors, fatal frame) lets hope this trend continues