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.
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.
The world's largest drug manufacturer is facing steep
competition from a slew of smaller
generic players, and the recent loss of patent protection
on its major branded drug, Copaxone, is threatening Teva's profit margins.
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.
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.
When Janssen Pharmaceuticals, the R&D arm of pharma giant J&J, decided they were going to focus
on novel therapeutics of big impact, rather than follow the
competition's focus
on branded
generics or biosimilars, they completely redesigned how they could tackle that goal by opening five so - called innovation centers.
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.
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.
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.
Having established that
generic producers were potential competitors of Lundbeck, it was inevitable
on the facts to regard the agreements at issue as being restrictive of
competition by object.
Companies to focus
on complex products as tough
competition in
generics, customer consolidation impact profits
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.