Sentences with phrase «generic competition in»

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

This New Jersey - based drugmaker posted a relatively flat year - over-year earnings comparison, which can be attributed to increases in generic competition in several key franchises, which was partially offset by ongoing cost - control initiatives.

Not exact matches

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.

And GSK expects more sales erosion for its ageing lung inhaler Advair in the key U.S. market - even before generic rivals are launched - due to increased pricing and competition.

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.

Nothing about the drug has changed in that time, and the fact that it's generic flies in the face of the argument that lack of generic competition is the reason for drastic price hikes.

A merger with Mylan would create a generics powerhouse with more than $ 27 billion in revenue and would give the company the heft it needs to cut costs and battle rising competition.

Given rising competition in the generics space, Teva could also use the additional size to gain back market share from Indian manufacturers such as Sun Pharmaceuticals.

They make adjustments for drugs that have been in development, drugs that will soon be subject to generic competition, and other factors so that they can estimate the funds available to stockholders during any given fiscal year.

The stock price plummeted after news of generic competition from Teva, but it has plenty of time to grow Korlym revenues and unlock value in the pipeline.

That pressure may intensify after Pfizer's second - quarter revenue missed Wall Street estimates on Tuesday due to a decline in sales of the blockbuster pneumonia vaccine Prevnar and generic competition for Pristiq for depression.

But it has been under pressure in the past 12 months due to greater competition from generic drugs and debt from its $ 32 billion acquisition of Baxalta in 2016, a widely criticized deal.

Government, your vision, the billions that have already been invested by the state of New York in this generic area, specifically, is the reason why you won that competition,» Biden said.

The maker of Suboxone, a blockbuster drug that helps people control their opioid addiction, engaged in anti-competitive business practices, coercing patients to use an oral strip because the tablets were set to face generic competition, according to a federal lawsuit filed by New York Attorney General Eric Schneiderman and 35 other Attorneys General.

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 counterpartIn 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 counterpartin 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.

«Competition and generic production really are the keys to reductions in prices.»

These include patent expirations, the rise of competition from generics, a downward pressure on drug prices, increasing scrutiny from regulators and health technology assessment bodies, pressure to move research offshore, and the crisis in R&D productivity.

Published in the Journal of Competition Law and Economics, the study shows that, on average, the percentage increase in prices is 4 - 4.5 times higher when entry - limiting deals are made and a generic is not available in the market, compared to when the generic is available but the branded and generic firms jointly set their profit - maximizing price.

* 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.

And because generics are available only for drugs whose patent has run out, the competition in the marketplace among manufacturers drives the price down.

In June 2009, Roche Pharmaceuticals pulled Accutane from the US market due to both increased competition from generics as well as increasing liability from personal - injury lawsuits.

This has greatly changed through time because of drug companies relying heavily on major drugs that often have problems discovered down the road or because of new branded and generic competition that didn't exist back in the early 1990s and before.

Whether it be trading on Bermuda Isles, running around and searching for turtles (leading to a challenge which, on the surface is very simple, though I found myself consistently making it difficult for myself) or pretty much falling into the generic RPG tropes of questing on behalf of someone else in order to gain money or XP and even a running competition which I still don't really understand the meaning of.

Represented AbbVie against Amgen in patent infringement litigation and inter partes reviews related to Amgen's FDA application for a biosimilar (generic) version of Humira (adalimumab) under the Biologics Price Competition and Innovation Act (BPCIA).

Dr. Hill's work has included serving as trial counsel for plaintiffs and defendants in patent infringement suits involving breast and ovarian cancer gene tests, radiology informatics, hospital information systems, orthopedic surgical devices, MRI diffusion tensor imaging, generic drugs in Hatch - Waxman patent litigation, and biologics in suits brought under the Biologics Price Competition and Innovation Act.

In cases involving the Hatch - Waxman Act and issues involving the expiration of pharmaceutical patents and competition between branded drug companies and generic manufacturers, our antitrust litigation graphics can illuminate a complicated industry and a complex regulatory scheme as below:

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....

In its May 13, 2014 Statement, the Bureau stated that «product life - cycle management strategies in the pharmaceutical sector are not inherently anti-competitive... However, life - cycle management strategies that are designed to impede competition from generic drug companies, such as product switching strategies, may cause significant harm to competition.&raquIn its May 13, 2014 Statement, the Bureau stated that «product life - cycle management strategies in the pharmaceutical sector are not inherently anti-competitive... However, life - cycle management strategies that are designed to impede competition from generic drug companies, such as product switching strategies, may cause significant harm to competition.&raquin the pharmaceutical sector are not inherently anti-competitive... However, life - cycle management strategies that are designed to impede competition from generic drug companies, such as product switching strategies, may cause significant harm to competition.»

The recent introduction of generic Lipitor in Canada is one example of the challenges facing pharma companies as current blockbusters come off patent and face generic competition.

Seyfarth Shaw is pleased to announce The BioLoquitur Bulletin: Drugs Available in 2018 for Generic Competition, published by the Life Sciences team.

Patent holders previously made such claims in order to delay the onset of competition from generic drug manufacturers, by preventing or delaying FDA approval of a generic manufacturer's Abbreviated New Drug Application (ANDA).

Companies to focus on complex products as tough competition in generics, customer consolidation impact profits

While it has become common and even expected that your resume will include a profile / summary statement, far too often they are just generic statements that do nothing to differentiate the individual from their competition in the job market.

With many drugs scheduled to lose their patents between now and 2020, competition in the generics market is set to increase.

Competition at the top is steep — and a resume that is generic or dated in how it describes you, and focuses on your responsibilities rather than your bottom - line impact — is not likely to bubble to the top.