Sentences with phrase «for generic drug manufacturers»

For a generic drug manufacturer to get the U.S. Food and Drug Administration's (FDA) stamp of approval, they must prove it is pharmaceutically equal to the name - brand version.

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.

FORTUNE — For Indian generic - drug manufacturer Ranbaxy, the past five years have consisted of an escalating series of regulatory and legal woes.

But Gilead's latest agreement with the Medicines Patent Pool aims to have new drugs ready for generic manufacturers as soon as they are available in high - income countries.

They estimate that generic - drug manufacturers should be able to produce the pills at $ 100 — 250 for a 12 - week course.

As it has for its HIV drugs, Gilead plans to provide patient assistance within the U.S., to license the drug (for a fee) to select generic manufacturers outside the U.S., and to lower prices in low - and middle - income countries.

* 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.

For example, sofosbuvir's manufacturer, Gilead Sciences Inc. of Foster City, California, sells the drug to Egypt at a discount and allows generic manufacturers in India to produce and sell in 91 poorer countries.

And because generics are available only for drugs whose patent has run out, the competition in the marketplace among manufacturers drives the price down.

Now that India, the world's fourth - largest manufacturer of generic drugs, is poised to make it a crime to copy patented drugs, neighboring countries such as Bangladesh with no such restrictions are lining up to capitalize on world demand for cheap meds, Bill Heinze reports.

Following the decision, three other courts adopted this minority position that brand - name manufacturers can be liable for injuries caused by the generic version of their drug.

Early last year, the Alabama Supreme Court ruled that a patient could sue a brand - name manufacturer for not warning about a drug's risks even if the medication involved is a generic version made by another company.

Pay - for - delay («PFD») agreements are agreements that are intended to delay the market entry of generic manufacturers with generic drugs in exchange for payments made by original pharmaceutical producers (i.e., holders of patents for an original branded drug).

The TPP requires parties to provide a «pre-approval» procedure for patented pharmaceuticals, with two options: 1) provide notice to a patent holder if a competitor applies to market an identical or similar drug during the patent term, along with an opportunity to seek a legal remedy such as a preliminary injunction before the generic drug is marketed; or 2) preclude marketing approval for a drug that is subject to another person's patent, unless the patent holder or original drug manufacturer consents.

New California Appellate Decision Makes Brand Name Drug Manufacturers Potentially Liable for Injuries Suffered by Consumers of Generic Drugs

Paul, Weiss client Nichi - Iko Pharmaceutical Co., Ltd., the largest generic drug manufacturer in Japan by sales, announced that it has agreed to acquire Sagent Pharmaceuticals, Inc. in an all - cash tender offer followed by a second - step cash merger, for a total consideration of approximately $ 736 million.

Plaintiff May Sue Manufacturer of Name - Brand Prescription Drug for Injury Allegedly Caused by Different Company's Generic Drug, Indiana Injury Lawyer Blog, February 28, 2013 Federal Statute Preempts State Products Liability Lawsuit Over Asbestos Exposure, According to Supreme Court: Kurns v. Railroad Friction Products Corp., Indiana Injury Lawyer Blog, October 18, 2012

[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.

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.

Now, the justices are trying to decide whether generic drug manufacturers can be sued in state court for design defects - especially when the generic version is an exact copy of its brand - name counterpart that the federal government had already approved.

Among other things, the Act included elaborate provisions governing the mechanisms through which a potential generic manufacturer may obtain marketing approval for a drug that has been patented by another party.

«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.»