Patent Expirations Through 2016 Predicted to Lower Brand Spending by $127 Billion

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Feb 10, 2014.

Dollar savings based on the conversion from brand to generic medications in the years from 2012 to 2016 will be unprecedented.

The U.S. share of global drug spending is expected to decline from 41 percent in 2006 to 31 percent by 2016, primarily due to patent expiries and slower brand growth. In the U.S. and led by Lipitor, $103 billion (44%) of 2011 brand spending will shift to generics with substantially lower prices. Major U.S. brand products, including Plavix, Seroquel, Singulair, Actos and Viagra undergo patent expiration in 2012, with the “patent cliff” continuing through 2016. Patent expirations for over 36 major brands, slower market uptake for new molecular entities, and efforts from health plans and regulators to curtail drug spending shrink brand dollars in the U.S. market through 2016.

Patent expirations up to 2016 will reduce brand spending in worldwide developed markets by $127 billion, but will be counterbalanced by generic spending, resulting in a five-year global savings of close to $106 billion. In Japan, the UK, France and Germany, many of the same or similar brands that were impacted in the U.S. will also lose patent protection. For example, in Japan, the use of generics is expected to increase as the government promotes policies to use lower-cost alternatives, and major products face generic competition. Overall, exclusivity loss in one or more developed markets will impact seven of the top 10 leading prescription drugs, including Lipitor, Plavix, Advair Diskus, Crestor, and Nexium.

Source: IMS Institute for Healthcare Informatics. The Global Use of Medicines: Outlook Through 2016. July 2012.

Appendix Notes:
Largest products (U.S.:>=$500Mn, Others: Top 2-5) with protection expiries in the 2012-2016 period, listed in descending order by country sales in constant US$ at Q4 2011 exchange rates. Estimates of protection expiry from information available as of March 31, 2012.
Source: IMS MIDAS, May 2012

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