Sentences with phrase «from generic drug manufacturers»

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).

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.

Not exact matches

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.

CVS has also engaged in a joint venture with drug distributor Cardinal Health Inc. to combine their purchases of generic drugs to extract a larger discount from manufacturers, which is generating higher margins.

That collection belonged to Marvin Schein, a manufacturer and distributor of generic drugs and medical products from Long Island who had spent years quietly buying paintings, porcelains and French furniture, many of them at auction.

[16] The SJC considered innovator liability to require such a modification given the certainty that a user of a generic drug will rely on the label fashioned by the brand - name manufacturer and as state law shields failure to warn claims from generic manufacturers, leaving plaintiffs without recourse for their injuries.

At issue is whether the Supreme Court should reinforce its 2011 ruling that protected generic drug manufacturers from state products liability claims accusing them of not warning about possibly dangerous side effects.

Represented a generic manufacturer that obtained a $ 3 million payment as compensation for lost profits during a temporary restraining order that prevented the FDA from approving the client's generic version of a popular allergy drug.

[17] The Regulations to the Ontario Drug Benefit Act [6] and the Drug Interchangeability and Dispensing Fee Act [7] were also amended to prevent pharmacies from controlling manufacturers who sell generic drugs under their own name but do not fabricate them.

«Any recognition of an outlier theory of liability permitting a generic drug consumer to bring an action against the brand manufacturer for an injury allegedly arising from the use of the generic drug would be plainly at odds with this public policy.»

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