Sentences with phrase «manufacturers of generic drugs»

A recent Supreme Court ruling is limiting court actions by injured patients who have filed claims against manufacturers of generic drugs.

Manufacturers of generic drugs do not suffer with to absorb or recover these costs.

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.

Relevant to the matter considered by the SJC, the Drug Price Competition and Patent Term Restoration Act, informally known as the «Hatch - Waxman Act» requires the «manufacturer of a generic drug [to] provide its users with a warning label that is identical to the label of the brand - name counterpart.»

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.

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.

According to the GAO report, 71 percent of all generic injectable cancer drugs sold in 2008 were produced by just three manufacturers, while 91 percent of the market share of injectable nutrients and supplements was held by just three pharmaceutical firms.

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 versdrug 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 versDrug Administration's (FDA) stamp of approval, they must prove it is pharmaceutically equal to the name - brand version.

Leave all medications and drugs in their original, labelled containers with the name of either the pharmacy that dispensed the medication or the manufacturer of the medication, and have on hand a copy of the original prescription, with both the generic and trade names of the drug.

Rather than take on the patent fight directly, the government gave its blessing to two drugs manufacturers who wanted to make a generic version of AZT.

* 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.

They visited: Sonny's Enterprises, largest car wash manufacturer in the United States; City Furniture, one million square foot corporate headquarters and distribution center; Sprout Loud and Rex 3, largest commercial printer in South Florida - high growth internet company; Marine Association of South Florida (MASF), 7 billion dollar industry in South Florida - Tour of Roscioli and Water Taxi on New River (view existing working Marinas); Mario Portillo - Actavis (soon to be Teva), largest generic drug manufacturer in the world; and Broward Health - Cora E. Braynon Family Center, health care professions.

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.

Examples include the 2015 acquisitions of Cordis (a manufacturer and distributor of interventional cardiology devices and endovascular solutions) and Harvard Drug (a distributor of generic and over-the-counter drugs); the 2013 acquisition of AssuraMed (distributor of home health care products); and the 2010 acquisitions of Kinray (distributor to independent pharmacies) and Yong Yu (a leading distributor in China).

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.

On an issue of first impression, however, the California Court of Appeals in Conte v. Wyeth, Inc. rejected this traditional view and held that a brand - name manufacturer's duty to warn extends to patients whose prescriptions are filled with the generic version of the drug.

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.

In other generic drug injury news, the U.S. Food and Drug Administration has suggested a new rule that would allow manufacturers of generic meds to independently include new side effect information to the labels of their medicatdrug injury news, the U.S. Food and Drug Administration has suggested a new rule that would allow manufacturers of generic meds to independently include new side effect information to the labels of their medicatDrug Administration has suggested a new rule that would allow manufacturers of generic meds to independently include new side effect information to the labels of their medication.

In cases involving the Hatch - Waxman Act and issues involving the expiration of pharmaceutical patents and competition between branded drug companies and generic manufacturers, our antitrust litigation graphics can illuminate a complicated industry and a complex regulatory scheme as below:

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 Jean Coutu Group were facing several challenges at the time including drug distribution reform and the purchase of a Quebec generic drug manufacturer.

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

[9] The potential lifelong side effects of this drug were not disclosed within the brand - name manufacturer's nor the mirrored generic manufacturer's warning label.

[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.

Specifically, in Rafferty v. Merck & Co., Inc., [4] the SJC held that plaintiffs who ingest the generic form of a drug may bring failure to warn claims against the brand - name manufacturer of the drug if the brand - name defendant acted recklessly by «intentionally fail [ing] to update the label on its drug while knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.»

Balancing these competing interests, the court held that, «a brand - name manufacturer that controls the contents of the label on a generic drug owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury.»

Mr. Simon also recently represented a generic brand drug company in an individual case alleging that the brand name manufacturer had filed false citizens petitions to delay the entry of the generic drug unto the market.

Today, a unanimous Supreme Court has reversed the Federal Circuit's decision and held that a generic manufacturer may invoke the counterclaim provision to force correction of a use code that inaccurately claims that a patent covers a particular method of using a drug.

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.

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.

Instead, generic evidence purportedly showing that the manufacturer marketed the drug as having less of risk of tardive dyskinesia and other extrapyramidal symptoms than other drugs was not tied to the prescriber's decisions with plaintiff.

[10] Prior to 2006, the price at which manufacturers could apply to list generic drugs in the Formulary was capped by regulations under the Actsat effectively 63 % of the price of the brand - name drug.

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 (ANdrug manufacturers, by preventing or delaying FDA approval of a generic manufacturer's Abbreviated New Drug Application (ANDrug Application (ANDA).

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.

«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.»

With generic drugs, it is not merely foreseeable but certain that the warning label provided by the brand - name manufacturer will be identical to the warning label provided by the generic manufacturer, and moreover that it will be relied on, not only by users of its own product, but also by users of the generic product.