Generics in the pipeline for 2017 in the US

Generics/Research | Posted 07/07/2017 post-comment0 Post your comment

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.

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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.

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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