Sentences with phrase «generic product in»

These settlement agreements attract concern from competition regulators due to their potential to take the form of so - called «pay - for - delay» or «reverse payment» arrangements where a generic manufacturer agrees to delay the launch of a competing generic product in exchange for a transfer of value (monetary or otherwise) from the brand company....

Not exact matches

The only time this is not true is when you're buying generic brands in the grocery store — you're often getting the same product that's in the brand - name packaging.

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 deal would create a generic medicine powerhouse, giving the combined company critical mass in specialty brands, generics, and over-the-counter and nutritional products.

There are two main parts to the investigation: 1) whether or not Mylan engaged in «product hopping,» or making small tweaks to the EpiPen in order to preserve IP protection; and 2) whether or not the pharma giant entered into certain agreements that stalled the entry of cheaper generics into the market.

In Africa, for example, some smaller pharmaceutical companies have profitably sold generic drugs and commercially developed local products.

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 SEC).

Mylan said it expects to launch the generic product «in several weeks» at a list price of $ 300 per generic EpiPen, compared with the branded product's cost of about $ 600.

The company said that it expected its revenues to decline in 2017 as several of its products lose their exclusivity and generic competitors enter the market.

With Merck facing a significant patent cliff in 2017, continued momentum in the new product cycle and a keen focus on cost controls will be key to offsetting generic erosion.

The company also said it anticipates recording non-cash intangible asset impairment charges, including goodwill, in the range of $ 230 million to $ 260 million on certain currently marketed and pipeline generic products as a result of continued intense competitive and pricing pressures.

Bain and Cinven, who earlier this year took control of Germany's Stada, are hoping to use the Merck unit as a buy - and - build platform for Stada, which makes generic drugs and consumer care products and had annual revenues of more than 2 billion euros in 2016, the sources said.

In the U.S., we have one of the largest product portfolios among all generic pharmaceutical companies.

Valeant Pharmaceuticals International, Inc. (NYSE / TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorder, eye health, neurology and branded generics.

Think: good selections of organic and natural products, a constantly changing roster of tempting «affordable luxury» goods and loads of in - house (generic) store brands.

It's the first so - called «pay for delay» case brought by the commission in which a drug's original maker agreed not to sell its own «authorized generic» version until well after a generic drugmaker began selling its product.

Because someone who is looking for something that specific is probably a much more qualified searcher for your product or service (presuming you're in the blogging space) than someone looking for something really generic.

And Easum is probably correct that much of the soft rock or pop music that he advocates for worship has become a kind of generic musical product, with no set of specifically worldly associations that would prevent its use in worship.

Meanwhile we're also seeing those offerings of generic jewelry, leather belts and toys made in China that are showing up on markets and festivals elsewehere as well, but the major part of the offerings are «prodotti tipici Calebresi», genuine local products.

The Canadian organic standards specify the generic substances that may be used in organic production, but they do not specify the product brand names that are acceptable.

It is not acceptable to take generic industrial chocolate and process it into finished product in a plant which is allergen - friendly.

South Australian senator Nick Xenophon says legislation to set up industry trademarks — such as for feta cheese in Greece or champagne in France — would help protect Australian generic products, such as Ugg boots and barramundi.

The bottle has a very unassuming white label with typewriter print, a generic font style found on many locally - made food products in the SVG.

Bacteria such as Staphylococcus aureus, Enterococcus, and generic E. coli are commonly found in the environment and are not considered pathogenic bacteria... Bacteria occur naturally on all raw food products from beef to blueberries so finding certain types on some foods in a grocery store is not surprising and should not be concerning,»

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.

In fact, a 2009 FDA study showed that of 2,070 orally administered generic drug products approved by the agency between 1996 to 2007, generics differ in bioequivalency from brand names, on average, by about 3.5 percent; less than two percent varied by more than 10 percenIn fact, a 2009 FDA study showed that of 2,070 orally administered generic drug products approved by the agency between 1996 to 2007, generics differ in bioequivalency from brand names, on average, by about 3.5 percent; less than two percent varied by more than 10 percenin bioequivalency from brand names, on average, by about 3.5 percent; less than two percent varied by more than 10 percent.

This trial used two generics considered the most disparate products on the market, and in a double - blind study, switched patients from one generic to the others throughout the course of the trial.

To further confirm the findings in this study, a single - dose study of the same generic lamotrigine products is currently underway.

A new study led by Michael Privitera, MD, professor of the Department of Neurology and director of the Epilepsy Center at the University of Cincinnati Neuroscience Institute, tested two generic lamotrigine (prescription antiepileptic) products and found no detectable difference in clinical effects among patients in the trial.

Whole Foods, Trader Joe's, and other health food stores are more careful than others about vetting the products on their shelves, but if you shop in a more generic grocery store, try looking for brands such as Niman Ranch and Organic Valley, which are farm cooperatives that stock natural and organic food.

When the first generic products first hit shelves in 1977, they barely made a dent in sales.

Overall, 87 % of pharmacies reported having a product like Plan B, Next Choice, or a similar generic in stock.

I've experienced nausea with other preworkouts in the past but, not once have I ever had a negative experience with Pre-Kaged because this product doesn't use any synthetic or generic ingredients.

Some companies claim the amazing benefits of betaine from the human studies that were conducted at the University of Connecticut using natural BetaPower ®, yet in their product they use generic, synthetic material.

However, the term «colloidal silver» has truly lost its scientific meaning, and should be considered a generic term for health products containing silver in a fluid medium.

PhD are the only brand in sports nutrition to add peptide bonded Leucine peptides to our Whey protein product, which sets the formula apart from the usual, generic online brands supplying whey as a commodity.

Hooper's film still works as a product of its era, but the premise of an overly generic white suburban family haunted by supernatural spirits in a PG - 13 throwdown isn't something that translates well to the modern age.

The aesthetics of Blade Runner in particular have had a pervasive influence on the genre, with the noirish future cityscape of the movie developed by Scott and his production designers being lazily cribbed by numerous sci - fi directors trying to bring some of that Blade Runner sophistication and elan to their own generic product.

One - liners are copy and pasted from Generic Screenplay Writer 2000 (possibly a real product), leaving audiences» foreheads red and swelled with the amount of times they end up slapping their heads in disbelief.

«The forums that have been established to advance the agenda of standardisation enable commercial actors to shape the demands of users, which in this case are often governments and may further contribute to growing demand for generic products,» the study warns.

In a world of generic, one - size - fits - all products, Freeman's is here to help you make that ride one - of - a-kind.

This is already happening where resellers already have their own ISBN prefixes, and is bound to increase if these downstream re-selling businesses find benefit in having products with unique ISBNs and the publisher has either not allocated an ISBN at all, has only allocated one to a generic.

What is not acceptable practice, and benefits no - one in the supply chain — whether publisher, retailer, librarian or consumer, is to display a generic number which is common to many products and unique to none.

Although it's of no consequence I'm slightly puzzled why there is a second magnet to the right of the long top edge - it doesn't appear to have any use as there is no corresponding metal tab to attach to - maybe I'm missing something or maybe it's a generic design feature applied in different ways to other similar products in the manufacturer's range.

The line drawings of the product that Apple submitted in its patent documents are extremely generic to say the least.

That said, if you have a generic cover that doesn't catch the reader's eye when they go to the product page or see it in the «If you liked this, you'll like that» recommendation list, folks won't click through to buy your e-book.

Consider, if a customer enters a generic english word that happens to also be a narrow trademark into a search engine, even a search engine that is searching for commercial products within the domain covered by the trademark, I guess it's technically possible (at least in the US) to simultaneously perform a trademark search on the term and not echo back the search term to the customer to avoid infringing the trademark on the search results page (I guess that would be serving the customer, according to the judge).

Or should it include products that self - describe as being «lush», the generic english word rather than the trademark, but I guess not any products that include «lush» in their name because they are infringing on the trademark (even if the name is a phrase that happens to contain the english word «lush»)?

However, unlike generic medicines in which the active ingredients are identical to the reference drugs, biosimilars are not identical due to such factors as the inherent complexity of biologics and proprietary details of the reference products.

In addition, the company has expanded relationships with generic manufacturers that include several benefits like higher service levels, greater clarity on generic cost of goods sold, and a more consistent product supply with fewer disruptions.