The main reason for the introduction of the Hatch-Waxman Act was to encourage the use of generics. Before Hatch-Waxman, only around a third of brand-name drugs had a generic available, and those that were available were not widely used. Compare this with the 89% of prescriptions that are now dispensed as generics in the US. In addition, between 2005 and 2014, generics have saved the US healthcare system almost US$1.7 trillion [1].

Generics can enter the US market following expiry of relevant patents and exclusivities. The median length of post-approval market exclusivity for widely used brand-name products is 12.5 years. Drug prices are reduced when generics enter the market. With just two generics makers for a particular drug, prices decline to 55% of the brand-name product price, with five manufacturers this decreases to 33% and with 15 manufacturers it decreases to 13% [2].

Recent price hikes have been seen for generics. For example, in August 2015 Turing Pharmaceuticals (Turing) increased the price of its newly acquired 62-year-old infectious disease drug Daraprim (pyrimethamine) by 5,000% from US$13.50 a tablet to US$750 [3].  Despite such cases, generics still represent very good value for money. In 2015, an analysis by the healthcare data company Truveris found that generics prices rose by only 2.93% on average compared to the prices for brand-name drugs, which increased by 14.77% [2].

Although the median length of exclusivity in the US is 12.5 years, brand-name manufacturers have found ways to extend this period through various means – often referred to as ‘evergreening’ [4]. It is therefore not always easy to predict when a new generic will hit the market. Sanchez and colleagues have listed the first-time generics approvals for the end of 2016 and predicted the expected first-time generics they expect to hit the market in 2017, see Table 1 [2].

Table 1: Selected 2016/2017 first-time generics

The authors concluded that ‘while brand-name medications require exclusivity, this can in some instances increase the burden of cost on patients. Generics can help to decrease this burden, but it is a delicate balance’.

Conflict of interest
The authors of the research paper [2] did not provide any conflict of interest statement.

Related article
Policies to address price rises in old generics 

References
1. GaBI Online - Generics and Biosimilars Initiative. Generics savings continue to climb in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Reports/Generics-savings-continue-to-climb-in-the-US
2. Sanchez CK, Trang DD, Cowey CK. Generic Drugs in the Pipeline: 2017 Update. US Pharm. 2017;42(6)(Generic Drugs suppl):31-37.
3. GaBI Online - Generics and Biosimilars Initiative. Senator calls for FTC to investigate drugmakers for antitrust violations [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Policies-Legislation/Senator-calls-for-FTC-to-investigate-drugmakers-for-antitrust-violations
4. GaBI Online - Generics and Biosimilars Initiative. The cost of evergreening strategies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabi-journal.net/news/the-cost-of-evergreening-strategies
5. GaBI Online - Generics and Biosimilars Initiative. First Advair generic launched in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Generics/News/First-Advair-generic-launched-in-the-US
6. GaBI Online - Generics and Biosimilars Initiative. Vytorin generic launched in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Generics/News/Vytorin-generic-launched-in-the-US
7. GaBI Online - Generics and Biosimilars Initiative. FDA approval for generics of ADHD drug Strattera [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Generics/News/FDA-approval-for-generics-of-ADHD-drug-Strattera
8. GaBI Online - Generics and Biosimilars Initiative. FDA approves Teva’s Viagra generic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Generics/News/FDA-approves-Teva-s-Viagra-generic

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