Sentences with phrase «other generic drug companies»

Sandoz and other generic drug companies filed Abbreviated New Drug Applications seeking approval to market a generic form of the drug.

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.

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.

That's an even rarer feat for a generic drug maker such as Mylan, which makes most of its revenue not on brand - name drugs, but on cheaper, equivalent versions of other companies» branded medications.

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.

The patent on the human form of it expired a while back; this meant that other drug companies could produce it under its generic name, fluoxetine.

We have represented clients in numerous other congressional investigations and oversight hearings, including a major internet services company in an investigation of its practices abroad, a chemical manufacturer in an investigation of the safety of its products, an insurance company in a hearing on the federal long term care insurance program, a financial services company in an investigation of credit card terms, and drug companies in investigations concerning such matters as payments to doctors, marketing practices, generic approvals, drug importation, and drug safety.