Slide 1: First to File and Beyond: Paragraph IV Business Strategies
First to File and Beyond: Paragraph IV Business Strategies THOMSON REUTERS INTELLECTUAL PROPERTY & SCIENCE GENERICS & API INTELLIGENCE Benjamin Burck Research Analyst and Project Manager Generics & API Intelligence benjamin.burck@thomsonreuters.com
Slide 2: Generics & API Intelligence at Thomson Reuters
Generics & API Intelligence at Thomson Reuters • 20 years of expertise in global generics • Unique research that tracks global generic API development and manufacturing activities • Intelligence appears in Newport Premium™ database for: – Strategy, Planning and Product Targeting – Business Developme
Slide 3: Agenda
Agenda • Hatch-Waxman Basics • Paragraph IV Strategies • Market Realities • Anticipating Competitors • Examples 3
Slide 4: Orange Book Patent Listing
Orange Book Patent Listing • 21 USC §355(b)(1) The applicant shall file with the application (NDA) the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a c
Slide 5: Orange Book Patent Listing
Orange Book Patent Listing • Patents that must be listed – Active ingredient (drug substance) – Formulation or composition (drug product) – Method of approved use • Patents that may not be listed – Processes – Packaging – Intermediates 5
Slide 6: ANDA Patent Certification
ANDA Patent Certification • 21 USC §355(j)(2)(A)(vii) [An ANDA shall contain] a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug… or which claims a use for such listed drug for which the applicant is seeking app
Slide 7: Incentives and Protections
Incentives and Protections • 180-day market exclusivity – First applicant to submit a substantially complete ANDA (first-to-file) – May be shared by multiple applicants – Subject to forfeiture • 30-month stay of FDA approval – If patent owner or NDA holder sues the ANDA applicant for patent infringe
Slide 8: ANDA Submission
ANDA Submission • New Chemical Entity (NCE) Exclusivity – Five year data exclusivity from the date of first NDA approval for products containing chemical entities never previously approved by FDA – ANDAs with Paragraph IV certification may be submitted four years after regulatory approval (NCE -1),
Slide 9: Lawsuits are an ordinary and expected part of the process
“Lawsuits such as these are an ordinary and expected part of the process of obtaining approval to commercialize a generic drug product in the United States.” 9
Slide 10: First-Time Generic Approvals 2007-2011
First-Time Generic Approvals 2007-2011 Source: Newport Premium™ 10
Slide 11: Possible Generic Paragraph IV Strategies
Possible Generic Paragraph IV Strategies Targets Market Position • Everything • First filer • Blockbusters • Subsequent filer – Limited competition • Niche Products – Highly competitive market – Formulation – Therapeutic Class – Limited API – Limited Sales • Line Extension 11
Slide 12: Generic Strategies
Generic Strategies • We plan to continue to expand our Global Division through targeted ANDAs and a first-to-file and first- to-market strategy. Our products and product candidates are generally difficult to formulate and manufacture, providing certain barriers to entry for potential competitors. (I
Slide 13: Paragraph IV Reality
Paragraph IV Reality • Any product may be a generic target • More companies are pursuing a Paragraph IV strategy • Challenges to complex products are increasing • Competition and specialization in the generic industry has led to products with $20 million or less in sales being considered opportuniti
Slide 14: Gralise (gabapentin)
Gralise (gabapentin) First FDA Approval January 28, 2011 U.S. Product Launch October 10, 2011 First ANDA Submission October 31, 2011 NDA Holder Depomed US Sales $ 0.5M (October – December 2011) (Source: Depomed ) Orange Book Patents Patent No Expiration 6,340,475 September 19, 2016 6,488,962 June 20
Slide 15: First Paragraph IV Patent Certifications Posted by FDA
First Paragraph IV Patent Certifications Posted by FDA Source: Newport Premium™ 15
Slide 16: Corporate Groups Associated with Paragraph IV Patent Certifications
Corporate Groups Associated with Paragraph IV Patent Certifications Source: Newport Premium™ 16
Slide 17: Top Paragraph IV Filers by Group
Top Paragraph IV Filers by Group Source: Newport Premium™ 17
Slide 18: Market Reality
Market Reality • Price erodes with each generic entrant • Price erosion continues as the generic market matures • Aggressive individual players can greatly affect the price for all • First filer’s market share advantage persists after additional generic entry • Authorized generics are to be expected
Slide 19: Known ANDA Filers per Challenged Product
Known ANDA Filers per Challenged Product Source: Newport Premium™ 19
Slide 20: First Filers
First Filers • Settlement leverage • Limited competition at launch • Higher initial price • “First Mover” market share • Marketing message 20
Slide 21: NCE-1 Opportunities
NCE-1 Opportunities Source: Newport Premium™ 21
Slide 22: 2008 NCE-1 Products
2008 NCE -1 Products Trade Name Active Ingredient Dose Form # of Known P IV ANDAs Sensipar cinacalcet hydrochloride Tablet 1 Enablex darifenacin hydrobromide Extended-release tablet 3 Lovaza omega-3 acid ethyl esters Capsule 3 Cymbalta duloxetine hydrochloride Delayed-release capsule 9 Tarceva erlot
Slide 23: Subsequent Filers
Subsequent Filers • Travel a worn path – Lower litigation costs – Known legal arguments – Settlement precedent • More informed decisions • Authorized generic deal? 23
Slide 24: Lunesta (eszopiclone)
Lunesta (eszopiclone) First FDA Approval December 15, 2004 NCE Exclusivity December 15, 2009 First ANDA Submission December 15, 2008 NDA Holder Sepracor (now Sunovion) US Sales $ 774.5M (12 months ending September 30, 2011) (Source: IMS Health) Orange Book Patents Patent No Expiration 6,319,926 Janu
Slide 25: Lunesta (eszopiclone): Mylan
Lunesta (eszopiclone): Mylan Paragraph IV Notification March 10, 2009 (Alphapharm) DMF Manufacturer Submission Date Matrix Laboratories March 25, 2008 Related Patents Primary Patent Patent Type Priority Date WO-2006136866 Process June 21, 2005 WO-2007232537 Formulation April 26, 2006 WO-2007124025 P
Slide 26: Lunesta (eszopiclone): Teva
Lunesta (eszopiclone): Teva Paragraph IV Notification February 9, 2009 DMF Manufacturer Submission Date TAPI Puerto Rico November 14, 2008 Related Patents Primary Patent Patent Type Priority Date WO-2007109799 Product (derivative) March 23, 2006 WO-2007124025 Process April 20, 2006 WO-2008094690 Pro
Slide 27: Lunesta (eszopiclone): Some Others Involved
Lunesta (eszopiclone): Some Others Involved Dr. Reddy’s Laboratories Patent September 5, 2005 API Commercially Available in Newport March 9, 2007 DMF Submitted September 13, 2008 Farmak Patent (Czech Republic) August 11, 2000 API Commercially Available in Newport January 18, 2006 DMF Submitted March
Slide 28: Bystolic (nebivolol HCl)
Bystolic (nebivolol HCl) First FDA Approval December 17, 2007 NCE Exclusivity December 17, 2012 First ANDA Submission December 19, 2011 NDA Holder Forest Laboratories US Sales $ 341.1M (12 months ending September 30, 2011) (Source: IMS Health) Orange Book Patents Patent No Expiration 5,759,580 June
Slide 29: 180-Day Exclusivity Forfeiture
180-Day Exclusivity Forfeiture Generic exclusivity is forfeited for failure to market upon the later of: The earlier of: 75 days after any of the – 75 days after approval of the first following with respect to applicant’s ANDA any applicant with tentative – 30 months after the date of ANDA submissio
Slide 30: Integrilin (eptifibatide)
Integrilin (eptifibatide) First FDA Approval December 15, 2004 First ANDA Submission September 30, 2008 NDA Holder Schering (Merck) ANDA Filer Teva Orange Book Patents Patent No Expiration 5,686,570 November 11, 2014 5,747,447 May 5, 2015 5,756,451 November 11, 2014 5,807,825 September 15, 2015 5,59
Slide 31: Kaletra (lopinavir/ritonavir)
Kaletra (lopinavir/ritonavir) First FDA Approval October 28, 2005 First ANDA Submission December 23, 2008 NDA Holder Abbott ANDA Filer Mylan Orange Book Patents Patent No Expiration (including PED exclusivity) 5,541,206 Jan 30, 2014 5,648,497 Jan 15, 2015 5,886,036 May 19, 2014 5,914,332 Jun 13, 201
Slide 32: Thank You!
Thank You! Benjamin Burck Research Analyst and Project Manager Thomson Reuters +1 207 871 9700 x35 benjamin.burck@thomsonreuters.com thomsonreuters.com 32