Genia Long

Recent trends in brand-name and generic drug competition

Abstract Objective: To provide evidence on recent trends in: (1) market exclusivity periods (MEPs, the time between launch of a brand-name drug and its first generic competitor) for new molecular entities (NMEs); (2) the likelihood and timing of patent challenges under Paragraph IV of the Hatch-Waxman Act; and (3) generic drug penetration. Methods: IMS Health National Sales Perspectives data were used to calculate MEPs for the 257 NMEs experiencing initial generic entry between January 1995 and September 2012 and the number of generic competitors for 12 months afterwards, by level of annual sales prior to generic entry and time period. The likelihood and timing of Paragraph IV challenge were calculated using data from Abbreviated New Drug Approval (ANDA) approval letters, the FDA website, and public information searches to identify drugs experiencing Paragraph IV filings, and the first filing date. Results: For drugs experiencing initial generic entry in 2011–2012, the MEP was 12.6 years for drugs with sales greater than

Updated trends in US brand-name and generic drug competition

100 million (in 2008 dollars) in the year prior to generic entry, 12.9 years overall. After generic entry, the brand rapidly lost sales, with average brand unit share of 16% at 1 year; 11% for NMEs with pre-generic entry sales of at least

Data exclusivity for biologics

250 million (in 2008 dollars). Over 80% of NMEs experiencing 2011–2012 initial generic entry had faced at least one Paragraph IV challenge from a generic manufacturer. These challenges were filed relatively early in the brand-name drug life cycle: within 7 years after brand launch, on average. Limitations: Analyses, including Paragraph IV calculations, were restricted to NMEs where generic entry had occurred. Conclusion: Pharmaceutical competition continues to evolve; while the average MEP below 13 years for 2011–2012 remains consistent with prior research, Paragraph IV challenges are increasingly frequent and occur earlier, and generic share erosion has intensified.

The importance of patents to innovation: updated cross-industry comparisons with biopharmaceuticals.

Abstract Objective: To provide updated evidence on US trends in: market exclusivity periods (MEPs, time between brand-name drug launch and first generic competitors) for new molecular entities (NMEs); likelihood, timing and number of Hatch-Waxman Act Paragraph IV patent challenges; and generic drug penetration. Methods: This study used IMS Health National Sales PerspectivesTM US data to calculate MEPs for the 288 NMEs experiencing initial generic entry between January 1995 and December 2014, the number of generic competitors for 12 months afterward (by level of annual sales prior to generic entry), and generic penetration rates. The likelihood, timing and number of Paragraph IV challengers were calculated using data from Abbreviated New Drug Approval (ANDA) letters, the FDA website, public information searches, and ParagraphFour.com. Results: For drugs experiencing initial generic entry in 2013–2014, the MEP was 12.5 years for drugs with sales greater than

Evolving provider payment models and patient access to innovative medical technology

250 million (in 2008 dollars) in the year prior to generic entry (

The Market For Follow-On Biologics: How Will It Evolve?

250 million + NMEs), 13.6 years overall. After generic entry, brands rapidly lost sales, with their average unit share being 7% at 1 year for

Evolving Brand-Name And Generic Drug Competition May Warrant A Revision Of The Hatch-Waxman Act

250 million + NMEs, 12% overall. Ninety-four percent of

The Roles Of Patents And Research And Development Incentives In Biopharmaceutical Innovation

250 million + NMEs experiencing initial generic entry in 2013–2014 had faced at least one Paragraph IV challenge, an average of 5.2 years after brand launch (76% and 5.9 years for all NMEs). NMEs faced an average of 5.1 and 6.2 Paragraph IV challenges per NME, for all and

Implementation of the Biosimilar Pathway: Economic and Policy Issues

250 million + NMEs, respectively. Limitations: Analyses, including Paragraph IV calculations, were restricted to NMEs where generic entry had occurred. Conclusion: The average 2013–2014 MEP of 12.5 years for

Biopharmaceutical Innovation The Roles Of Patents And Research And Development Incentives In

250 million + NMEs, 13.6 overall remains consistent with prior research. MEPs are lower, and Paragraph IV challenges are more frequent and occur earlier for