scholarly journals Brand-name drug companies fail to meet R&D commitments

2006 ◽  
Vol 175 (4) ◽  
pp. 344-344
Author(s):  
W. Kondro
Keyword(s):  
Brand Name ◽  
Drug Companies

Drug Patent Settlements Around the World

2017 ◽  
Vol 62 (4) ◽  
pp. 770-785
Author(s):  
Michael A. Carrier
Keyword(s):  
The United States ◽  
European Law ◽  
Patent Litigation ◽  
Brand Name ◽  
Rule Of Reason ◽  
Drug Companies ◽  
Drug Patent ◽  
The World ◽  
The Law ◽  
The Uk

One of the most pressing antitrust issues today involves settlements by which brand-name drug companies pay generic firms to settle patent litigation and delay entering the market. Whether this activity constitutes an antitrust violation is a subject that has occupied courts and enforcement agencies around the world. This article focuses on the law in the United States, where the law is most developed. It explores the issues courts have addressed after the Supreme Court’s 2013 decision in FTC v. Actavis, including payment, the patent merits, the Rule of Reason, pleading requirements, causation, and state law. The article also analyzes European law and enforcement, in particular seven monitoring reports and two significant rulings against companies. Finally, it briefly discusses developments in the UK, Canada, India, and Korea.

Product Switching in the Pharmaceutical Industry: Ripe for Antitrust Scrutiny?

2010 ◽  
Vol 7 (2) ◽  
pp. 119-130
Author(s):  
Seth Silber ◽  
Kara Kuritz
Keyword(s):  
Market Share ◽  
Generic Drug ◽  
Prescription Drugs ◽  
New Drugs ◽  
Pharmaceutical Companies ◽  
Brand Name ◽  
Generic Entry ◽  
Product Switching ◽  
Drug Companies ◽  
Antitrust Laws

Since the Hatch-Waxman Act was enacted in 1984, generic drug companies have benefited from its provisions to facilitate approval of generic alternatives to brand-name pharmaceuticals. Upon generic entry, consumers of prescription drugs benefit from large discounts as brand manufacturers lose significant market share to these lower-priced alternatives. Over time, brand-name drug manufacturers have undertaken strategies, such as ‘product switching’ or ‘product hopping’, that may delay or prevent generic entry and protect their market share. Generic drug manufacturers, drug purchasers and antitrust authorities have begun looking to the antitrust laws to address these strategies and their impact on generic entry. This article discusses the regulatory framework under which pharmaceutical companies introduce new drugs, two prominent cases in which courts have wrestled with whether product switching violates the antitrust laws, factors that might support an antitrust claim for product switching, and the FTC's interest in challenging product switching.

Recent Developments in Health Law

2012 ◽  
Vol 40 (1) ◽  
pp. 165-170
Author(s):  
Brenna Jenny
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
Tort Law ◽  
Drug Manufacturer ◽  
Recent Change ◽  
Brand Name ◽  
Drug Companies ◽  
Drug Regulations ◽  
Recent Developments ◽  
The Individual

When the Supreme Court in PLIVA v. Mensing determined that certain state tort law failure-to-warn claims against generic drug companies were pre-empted by federal drug regulations, the pronouncement was met with substantial criticism. In light of the Court's decision two years earlier in Wyeth v. Levine, where the Court allowed a similar claim against a brand-name drug manufacturer to proceed, many complained the resulting Levine-Mensing dichotomy created an arbitrary distinction between brand-name and generic drugs, allowing an injured patient's ability to recover to hinge solely on the happenstance of whether the individual had taken the brand-name or generic version. But, although Mensing cut back significantly on the ability of plaintiffs to make state law failure-to-warn claims against generic drug manufacturers, the case did not completely prohibit such claims. Instead, the Court banned only failure-to-warn claims premised on an argument that the generic drug company needed to change its label in order to meet state tort law duties. If plaintiffs can advance other theories independent of a formal label change, such as a failure to adequately warn a physician about a recent change to the drug's label, then they may still be able to proceed against generic drug manufacturers.

Proposed Solutions for Rising Drug Prices

2021 ◽  
pp. 38-61
Author(s):  
Neumann Peter J. ◽  
Cohen Joshua T. ◽  
Ollendorf Daniel A
Keyword(s):  
Collective Bargaining ◽  
Generic Drug ◽  
New Drugs ◽  
Patient Access ◽  
Brand Name ◽  
Pharmacy Benefit ◽  
High Drug ◽  
Drug Prices ◽  
Market Protection ◽  
Drug Companies

This chapter explores proposed solutions for high drug prices. They include measures to rein in “middlemen” pharmacy benefit managers who may artificially inflate prices; increase generic drug competition to prevent price spikes for older, off-patent drugs; enhance competition for new drugs after brand-name products reach the intended period of market protection; align US drug prices with the lower prices available in other wealthy countries; and leverage the collective bargaining power of government payers to compel drug companies to accept lower prices for their products. Policies that force drug prices down can save money but risk choking off the development of important new advances, limiting patient access to their health benefits. Moreover, the policy solutions typically offered are incremental solutions that will likely put a modest dent in the nation’s $500 billion annual drug bill. Most important, they fail to link a drug’s price to its value.

Authorized generics vs. branded generics: A perspective

2020 ◽  
pp. 174113432094777
Author(s):  
Bharti Latwal ◽  
Amrish Chandra
Keyword(s):  
Lower Cost ◽  
Brand Name ◽  
Drug Companies ◽  
Generic Medications ◽  
Branded Drugs ◽  
The Masses ◽  
Brand Name Drugs ◽  
Day By Day

Nowadays, there are many generic medications available in the market. Their sale is increasing day by day due to their lower cost and affordability by most of the customers. Generic medications are pharmaceuticals that are therapeutically equivalent to an original off patent drug. Both authorized generics and branded generics are the versions of generic medications. They offer lucrative business and increase competition for ordinary generics. They supply medications having quality of branded drugs at lower prices and this establishes their recognition among the masses who earlier has limited options to buy only brand-name drugs. They are cheaper than brand name drugs but costlier than ordinary generics. Authorized generics are sold only by Innovator Companies but the branded generics can be sold by both innovator companies and generic companies. They both are different from one another and have their own impact on the brand drug companies, generic companies and consumers.

scholarly journals The trend in patent infringement litigation against generic drugs or biosimilars in Japan

2019 ◽  
Vol 15 (1) ◽  
pp. 10-17
Author(s):  
Sachiko Masuda
Keyword(s):  
Drug Use ◽  
Market Entry ◽  
Generic Drugs ◽  
Patent Infringement ◽  
Brand Name ◽  
Market Environment ◽  
Institutional Reforms ◽  
Drug Companies ◽  
Emerging Issues ◽  
Legislative Changes

The timing of market entry for generic drugs or biosimilars based on patent expiration is not always clear for producers of generic drugs and biosimilars or brand-name drug companies, because of an uncertainty due to patent infringement, the market environment, and legislation. In Japan, the policy of promoting the use of generic drugs began in the early 2000s, and the government’s target for generic drug use rate is 80% by 2020. In addition to this drastic change in the market environment, changes in legislation have complicated the timing of market entry for generic drugs and biosimilars. Although there is a relatively low number of patent infringement lawsuits filed against producers of generic drugs and biosimilars each year, emerging litigation issues are likely influenced by recent changes in the market environment and legislation. This article provides an overview of recent legislative changes, analyzes the trends in patent infringement litigation, and discusses litigation issues related to the stable supply of generic drugs and biosimilars in Japan. In light of the emerging issues in this field, producers of generic drugs and biosimilars will require more diligence to avoid patent infringement, and institutional reforms are suggested to reduce an increase in patent infringement litigation.

Competition Policy Issue In Drug Companies: A Management Accountant’s View

2003 ◽  
Vol 1 (1) ◽  
pp. 13-31
Author(s):  
Tengku Akbar Tengku Abdullah
Keyword(s):  
Price Discrimination ◽  
Competition Policy ◽  
Policy Issue ◽  
Diagnostic Tools ◽  
Brand Name ◽  
Special Issue ◽  
Policy Issues ◽  
Drug Companies ◽  
The Us ◽  
Antitrust Legislation

International Journal of the Economics of Business produced a special issue on “Symposium on the US brand name prescription drug antitrust legislation” in 1997. This case involved fascinating scientific and policy issues including price discrimination. Economic scholars contributed to the debate. This paper gives a management accountant’s view on the competition policy issue. It clarifies the competition policy issue diagnostic tools (an analytical construct and concepts of cost). These diagnostic tools haave been able to give insights into the issue.

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