The ‘Generic Competition Paradox’ Revisited

2021 ◽  
pp. 1-13
Author(s):  
Atanu Saha ◽  
Yong Xu
Keyword(s):  
Generic Competition

Short Fictional Forms and the Rise of the Tale

2018 ◽  
Author(s):  
Anthony Jarrells
Keyword(s):  
The Novel ◽  
Generic Competition ◽  
Dynamic Field ◽  
Literary Annuals

This chapter discusses some of the short fictional forms that persisted in as well as alongside the novel. These short fictional forms include chapbook and bluebook abridgements, religious tracts, and what would come to be called—by the end of the period covered here—the tale. Together, these forms highlight the dynamic field of writing that comprised the years that span the novel's rise and canonization. As it appeared in stand-alone collections, magazines, and literary annuals, the tale pushed the novel to consolidate its boundaries even as it developed its own mix of features to challenge the novel on its established ground. In the end, however, the novel won out in its generic competition with half-told and mangled tales.

Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

2022 ◽  
Author(s):  
Bryan S. Walsh ◽  
Aaron S. Kesselheim ◽  
Ameet Sarpatwari ◽  
Benjamin N. Rome
Keyword(s):  
Patent Protection ◽  
Cross Sectional Study ◽  
Myelogenous Leukemia ◽  
Brand Name ◽  
Generic Competition ◽  
Cross Sectional ◽  
The Us ◽  
Lower Drug ◽  
The Impact ◽  
Brand Name Drugs

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

Blockbusters and Bombs

2016 ◽  
Author(s):  
Michael Kinch
Keyword(s):  
Guinea Pig ◽  
Research And Development ◽  
New Technologies ◽  
New Products ◽  
Cancer Drug ◽  
Generic Medicines ◽  
Short Term ◽  
Generic Competition ◽  
The Cost

The first indications of future trouble are identified. For most of history, new medicines arise from nature but this approach came into question as evidenced by the development of the cancer drug Taxol. As understanding of biology and chemistry incraesed, a degree of over-confidence arose as researchers assumed that new technologies would allow them to predict the most effective medicines. These changes were a response to an environment confronting twin pressures in the form of rising generic medicines coupled with ever more costly research and development activities needed to develop new products to replace those devastated by generic competition. These issues were exacerbated by a rising dependence upon “blockbuster” products, which conveyed short-term revenues but inevitably needed to be replaced by even more profitable products once generic competition intervened. Dependence on blockbusters was exemplified by the story of ulcer medicines, which was disrupted by an audacious study by an investigator who used himself as a Guinea pig to make his point. As such risks increased, the industry became more cautious and the race was on to make incremental improvements upon competitors’ products. All the while the cost of developing new medicines continued to escalate.

The Case of Synthroid (A): Marketing a Drug Coming Off Patent

2017 ◽  
pp. 1-19
Author(s):  
Alice M. Tybout ◽  
Julie Hennessy ◽  
Natalie Fahey ◽  
Charlotte Snyder
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Ethical Issues ◽  
The United States ◽  
Insurance Companies ◽  
List Type ◽  
Generic Competition ◽  
Global Challenge ◽  
History Of ◽  
Competitive Products

The case tells the story of Synthroid from its development in 1958 as the first synthetic thyroxine molecule to its competition against generic equivalents in 2004. The case introduces students to the pharmaceutical industry, its practices, and some of the complexities of pricing and drug choice, with drug manufacturers, insurance companies, physicians, pharmacists, and patients all playing a role. It also provides a primer on hypothyroidism, its symptoms, and its treatment.Because Synthroid was developed and introduced before FDA regulations and drug standards of identity were fully established, it was difficult for competitors to get their drugs certified as identical to Synthroid. Through a series of efforts with physicians, especially endocrinologists, Synthroid's owners were able to maintain the perception for forty-six years that Synthroid was uniquely effective. In 2004, however, the FDA declared several competitive products to be bioequivalent to Synthroid, which posed a significant challenge to its owner, Abbott Laboratories. Students are challenged to consider options to maintain the drug's unit volume, revenue, and/or profit in these difficult circumstances.The case is written in two parts. The (A) case provides background on the history of the drug, the pharmaceutical industry and its marketing practices, and hypothyroidism and its treatment, and it concludes in 2004 as Abbott's marketers face the impending challenge of defending the Synthroid business against generic competition. The (B) case describes what Abbott actually did to maintain its share in the United States and outlines its strategy in India, a market without patent protection for pharmaceuticals.After analyzing the case students should be able to: Describe strategies that branded competitors can use to defend their business from lower-priced competition Understand the basics of pharmaceutical marketing and pricing, including the global challenge of defending branded drugs against generic equivalents Discuss ethical issues in the marketing of high-margin branded products that have lower-priced alternatives, especially in the healthcare industry

Therapeutic Equivalence and the Generic Competition Paradox

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Munirul Haque Nabin ◽  
Vijay Mohan ◽  
Aaron Nicholas ◽  
Pasquale M. Sgro
Keyword(s):  
Simple Model ◽  
Generic Drug ◽  
Generic Drugs ◽  
Large Body ◽  
Medical Community ◽  
Therapeutic Equivalence ◽  
Generic Competition ◽  
Branded Drug ◽  
Fda Approval ◽  
Generic Products

Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.

Generic Competition in Canada

1994 ◽  
Vol 6 (5) ◽  
pp. 480-482
Author(s):  
John W. Steele
Keyword(s):  
Generic Competition
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