ANDA at 35 - Sterne, Kessler, Goldstein & Fox · 2020-04-01 · and effectiveness) • 1970 –...
Transcript of ANDA at 35 - Sterne, Kessler, Goldstein & Fox · 2020-04-01 · and effectiveness) • 1970 –...
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Technical Minds. Legal Muscle.
Focus on Pharma Panel Discussion
ANDA at 35
Moderator: J.C. Rozendaal
October 25, 2019
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• Timeline and Milestones• Statistics and Trends• Discussion topics
Contents
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Timeline and Milestones
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Generic Drugs in the U.S.A Brief Timeline
Pre-Hatch Waxman• 1962 – New FDA
authority (safety and effectiveness)
• 1970 – Abbreviated approvals
• 1974-80 –Substitutions allowed
• 1979-83 – Slow progress (19 generics approved by ‘83)
1984Hatch-WaxmanSimplifies path
for generic approval
2003MMA
Addresses issues identified in FDA review of
P IV cases
2011AIA
Introduces PTAB, new joinder rules
Generic substitution rate grows from 12% in 1984 to
63% by mid-’00s
Dramatic increase in number of law suits, certifications,
and competition
Looking Forward• Intense competition
clustered around many NCE dates
• Falling margins for branded and generic companies
• Consolidation in big pharma
• Growing focus on biologic drugs (BPCIA)
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Statistics and Trends
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Rapid Growth of ChallengesPost-MMA and Again Post-Recession
Source: Paragraph Four Reports, 2019
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District Court OutcomesPost-MMA Cases (2003-2018)
Source: Paragraph Four Reports, 2019
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Product by Product: Many Filers, but Not All Products Draw P IV Challenges
Source: Paragraph Four Reports, 2019
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ANDA Cases at the PTABA Spike and a Tailing-off
Source: Paragraph Four Reports, 2019
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IPR Outcomes – 2012-2018
Settled Pre-Institution
14%
Institution Denied32%
Settled Post-Institution
12%
Patent Survives FWD23%
Patent Invalidated at
FWD19%
IPR Outcomes Associated with ANDA CasesOctober 1, 2012-September 30, 2018
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Discussion Topics
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• Multiple filers and the potential for hyper-competition on selected drugs (i.e., easy to manufacture, APIs available, large sales volumes, one or few OB patents, etc.)− Innovator perspective on strategic options and implications− Generic perspective on strategic options and implications− Looking forward, should we expect another wave of new competitors out of China?
• District Court or PTAB or both?• Success of patent thicket?• Future of life cycle management?• Political overhang related to the price of drugs?
Strategies and Implications Innovators and Generics