Generics in the pipeline for 2017 in the US

Since the Hatch-Waxman Act was passed in 1984, the approval process for generics has been simplified. The law created an abbreviated approval pathway for generics making it easier for generics to enter the market and expanding access to important — often life-saving — drugs.

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

Originator	Manufacturer	Generic name	Indication	Approval status
Zetia	Merck	ezetimibe	Alzheimer’s disease	Generic available
Azilect	Teva	rasagiline	Parkinson’s disease	Generic available
Namzaric	Allergan	memantine	Alzheimer’s disease	Generic available
Pristiq	Wyeth	desvenlafaxine	Antidepressant	Generic available
Advair diskus	GSK	fluticasone/ salmeterol	Asthma & COPD	Generic available [5]
Vytorin	Merck	ezetimibe/ simvastatin	High cholesterol	Generic available [6]
Strattera	Eli Lilly	atomoxetine	ADHD	Generic available [7]
Relpax	Pfizer	eletriptan	Migraine	Generic available
Byetta	Astra Zeneca	exenatide	Diabetes	Expected on US market October 2017
Prezista	Janssen	darunavir	HIV	Tentative approval: Expected on US market November 2017
Virazole	Valeant	ribavirin	Antiviral	Generic available
Sustiva	Bristol-Myers Squibb	efavirenz	Antiviral	Tentative approval: Expected on US market December 2017
Truvada	Gilead	emtricitabine/ tenofovir	HIV	Tentative approval: Expected on US market December 2017
Viagra	Pfizer	sildenafil	Erectile dysfunction	Generic available [8]
Reyataz	Bristol-Myers Squibb	atazanavir	HIV	Tentative approval: Expected on US market December 2017
Viread	Gilead	tenofovir	Hepatitis B virus	Generic available
ADHD: attention deficit/hyperactivity disorder; COPD: chronic obstructive pulmonary disease; HIV: human immune-deficiency virus.

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.

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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