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.»
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.
Another bright spot could be the slowing in the decline of U.S.
generic drug prices, according to report
from Credit Suisse, citing data
from health information
company IQVIA.
(Next, Mylan wants to buy Ireland - based Perrigo (PRGO) to further transform itself
from a
generic prescription
drug maker to a more diversified healthcare
company, though Perrigo has so far rebuffed its overtures.)
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.
The
generic drug company tripled the discount patients can receive on the cost of EpiPen to $ 300, up
from the maximum $ 100 Mylan had previously offered with the use of its special «savings card.»
Allergan would also bolster Pfizer's «innovative» (i.e. brand - name)
drug business, which it internally separated
from its slower - growing «established» (i.e.
generic and non-patented)
drug division in 2014, further signaling that it may be planning to split into two different
companies altogether.
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.
FORTUNE — On Jan. 23, the FDA dropped a heavy hammer on the Indian
generic drug giant Ranbaxy Laboratories, announcing it will restrict imports
from the
company's manufacturing plant in Toansa, India.
The divestment would complete the
company's gradual shift away
from its original focus on
generic drugs and nuclear imaging toward branded specialty pharmaceuticals, which now comprise the bulk of its revenues.
Those
companies had sought approval
from the U.S. Food and
Drug Administration to sell a
generic version of Ampyra.
So, the
company can still benefit
from generic drug offerings.
Doctors, clinic staff and pharmacists, Malani says, can help patients identify options
from drug companies that might reduce costs by reducing copayments or overall price, and recommend
generic equivalents when available.
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.