Sentences with phrase «drugs under patent»

Even these entities have little power over newer drugs under patent or drugs with only one manufacturer.

And that applies for drugs under patent, which are typically more expensive to begin with, and generic drugs.

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.

Slavitt said EpiPen has patent protection, has no Food and Drug Administration - approved equivalents, and was approved by that agency under a «new drug application,» all of which make it a brand - name dDrug Administration - approved equivalents, and was approved by that agency under a «new drug application,» all of which make it a brand - name ddrug application,» all of which make it a brand - name drugdrug.

Controversial changes to drug patent and copyright rules required under Canada's recent trade deals will have manageable side effects, according to a new report from the C.D. Howe Institute.

One of the few negatives on an otherwise fairly positive day of trading was the 5 % decline of Reckitt Benckiser, producers of a drug used to help get drug users off of Heroin called Suboxone, which acts as a replacement for the Class A. Reckitt's patent for Suboxone is due to expire in the relatively near future, so they have been trying to push doctors and other pharmaceutical vendors towards their film version of the drug, which is still under patent and will be for quite some time.

Ok, so we have billions of pounds of synthetic chemicals consumed every year as patented drugs, with an army of degreed, licensed and doctored foot soldiers prescribing them recklessly under the once great banner of «medicine,» in an ongoing war against the body's virtually infinite potential to generate symptoms, most of which are — ironically — a means to heal from acute or chronic exposure to synthetic chemicals.

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.

According to the Seattle Times article, drug companies aren't very interested in rapamycin because it's no longer under patent.

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.

Canada's existing Patented Medicines (Notice of Compliance) Regulations currently establish a system similar to the Hatch - Waxman system in the United States, under which a drug manufacturer may list patents relevant to a drug on a patent list.

In the case of Apotex Inc. v. Eli Lily and Company, 2015 ONCA 305, Eli Lilly and Company and Eli Lilly Canada Inc. («Lilly») had used the process available under the regulatory scheme of the Patented Medicines (Notice of Compliance) Regulations, SOR / 93 -133, in order to keep Apotex's generic counterpart to Strattera (a drug used in the treatment of Attention Deficit Hyperactivity Disorder) off the market.

Last fall, Eli Lilly launched a $ 500 - million complaint under the North American Free Trade Agreement claiming Canada violated obligations to foreign investors by allowing its courts to invalidate patents for two of its drugs.

Prescription drugs that are no longer patent - protected and are sold by drug manufacturers under a different name than the original brand name drug.

The pharmaceutical industry is under pressure from every corner, with expiring patents on blockbuster drugs, research and development productivity on the wane and constant negative pricing pressure forcing the need to rationalise.