Generics Series: Authorized Generics Analysis Stemming the Generics Tide

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1 Generics Series: Authorized Generics Analysis Stemming the Generics Tide Report summary An overview of the authorized generics landscape, including drivers and resistors for both branded and generics players Understand what authorized generics are, and the strategic motivations which drive companies to use them An insight into which branded and generics companies entered into authorized generics agreements in the US between 2004 and 2008 Analysis of the extent of authorized generic market share capture during two years following launch, by brand value, therapeutic class, and dosage form An overview into what the future holds for authorized generics, in the US and Europe

2 About this report Introduction While the benefits of authorized generics to the branded industry are clearly apparent, the attitude of the generics industry is determined by individual company strategy. For those generics players that aggressively challenge patents, authorized generics are a threat to revenues, while for other smaller companies, authorized generics represent an opportunity to get to market quickly and easily. Authorized generic sale during the 180-day period of market exclusivity awarded to the first-to-file generics company in the US can accelerate price erosion, and therefore have pro-consumer benefits. However, many generics companies contend that the spectre of authorized generics is a deterrent to early market entry. It is the balance between these outcomes that will determine the extent to which authorized generics impact on the consumer. Key findings and highlights Given the benefits associated with own authorized generics, it is unsurprising that these dominated the data-set under investigation, with the Pfizer- Greenstone authorized generic combination by far the most frequent. The authorized generic launched at a greater discount to the branded drug than the conventional generic, in 65 per cent of agreements under analysis, reflecting the higher margins available to the authorized generics company which potentially neither developed, manufactured, nor obtained approval to market the drug. The greatest number of generic entrants was associated with the highest value branded products (with pre-generic quarterly sales in excess of $600m) in the data-set under analysis, with this group showing an average of 14 and 19 competitors at 1 and 2 years post generics launch. Reasons to buy Understand what authorized generics are, and the strategic motivations which drive companies to use them Understand the effect of brand value, therapeutic class, and dosage form on the relative success of authorized generics to gain generics market share Gain an insight into how the authorized generics landscape will evolve in the future Pre-generic brand value can often be a good indicator of the intensity of generic erosion that occurs following loss of patent protection Pam Narang, Datamonitor Analyst

3 Sample pages Frequency and Type of Authorized Generics Agreements Correlation Between Therapeutic Class and Generic Erosion Own generics dominate the authorized generics landscape in the US Although only one third of branded companies had the option to launch an own-ag between 2004 and 2008, these represented 45% (18) of all launches under investigation. Of the 40 authorized generic (AG) launches under analysis during this period in the US, a total of 14 branded and 14 generics companies were involved, with five of the generics companies constituting subsidiaries of larger branded companies, namely Forest and Inwood Labs, Johnson & Johnson and Patriot, Boehringer-Ingelheim and Roxane, Novartis and Sandoz, and Pfizer and Greenstone. Success of authorized generic launch by brand dosage form Figure 23 shows how authorized generic (AG) volume market share (as a proportion of total generics market) varied by dosage form in the US between 2004 and The number above each bar represents the month post launch that the AG achieved peak market share, while the value below the bar indicates the size of the decline in market share by the end of the 2-year period of analysis. Figure 23: Authorized generic volume market share dynamics by dosage form in the US, Figure 4 shows which branded and generics companies were involved in the AG agreements analyzed in this report during the period , and the number of such agreements. Figure 4: Authorized generic agreements in the US between 2004 and 2008 Source: Datamonitor; Food and Drug Administration, 2009; MIDAS sales data, IMS Health, D A T A M O N I T O R March 2009 Source: Datamonitor; Food and Drug Administration, 2009 D A T A M O N I T O R Peak AG share of the total generics volume market ranged from a mean of 69% for branded oral solutions (including lyophilized and reconstituted products), to 39% for drugs falling within the standard oral solid dose, with an average AG market share of 49%. The fall in AG market share, from its peak to that at 2 years after launch, was highly variable across It is unsurprising that the generics companies most frequently involved in AG agreements Greenstone and Sandoz are dose classes. both subsidiaries of larger branded companies, Pfizer and Novartis, respectively. In the face of impending generic incursion, marketing an own-ag is an entirely logical strategy, especially if the generic competitor in question has 180-days of marketing exclusivity, during which the own-ag can potentially capture half the generic market. Indeed, 180-day exclusivity was in operation for at least six of the 11 AGs fielded by Pfizer through Greenstone. Generics Series: Authorized Generics Analysis DMHC2549 Published 07/2009 Datamonitor. This brief is a licensed product and is not to be photocopied Page 16 Generics Series: Authorized Generics Analysis DMHC2549 Published 07/2009 Datamonitor. This brief is a licensed product and is not to be photocopied Page 55 Contact our customer service team for more sample pages... Europe tel: fax: Americas tel: fax: Middle East tel: fax: Asia Pacific tel: fax:

4 Table of contents ABOUT DATAMONITOR HEALTHCARE About the Strategic Pharmaceutical Analysis Team EXECUTIVE SUMMARY Strategic scoping and focus Methodology Datamonitor insight into the disease market Related reports AUTHORIZED GENERICS OVERVIEW Authorized generics as a tool for branded pharma to maximize market share The generics industry is split on the issue of authorized generics The impact of authorized generics on the consumer FREQUENCY AND TYPE OF AUTHORIZED GENERICS AGREEMENTS CORRELATION BETWEEN THERAPEUTIC CLASS AND GENERIC EROSION Brand therapeutic category and number of authorized generic launches Success of authorized generic launch by therapeutic class - Authorized generics within the immune and inflammatory disease, and central nervous system disorder classes lost little market share over 2 years - Authorized generics within the genitourinary, cardiovascular, and endocrine and metabolic disease classes lost most market share over 2 years Average generic erosion of brands by therapy class - Cardiovascular disease brands - Infectious disease brands - Central nervous system disease brands - Endocrine and metabolic disease brands - Oncology brands - Immune and inflammatory disease brands - Genitourinary disease brands - Respiratory disease brands CORRELATION BETWEEN DOSAGE FORM AND GENERIC EROSION The frequency of authorized generic agreements through Authorized generic agreements on the rise - The number of authorized generic agreements apparently peaked in 2006 Decisions regarding brand-generic authorized generic partnerships - Small and mid-sized generic companies benefit most from authorized generic deals - Own generics dominate the authorized generics landscape in the US CORRELATION BETWEEN BRAND VALUE AND GENERIC EROSION Brand market size and number of generic entrants Success of authorized generic launch by brand value Average generic erosion of brands by value - Brands with pre-generic quarterly revenues of less than $100m - Brands with pre-generic quarterly revenues between $100m and $200m - Brands with pre-generic quarterly revenues between $200m and $400m - Brands with pre-generic quarterly revenues between $400m and $600m - Brands with pre-generic quarterly revenues in excess of $600m Dosage form and number of authorized generic launches Success of authorized generic launch by brand dosage form - Authorized generics within the transdermal and oral solution classes lost little market share over 2 years - Authorized generics within the standard oral solids and injectable classes lost the greatest market share over 2 years - Average generic erosion by brand dosage form - Standard oral solid dose brands - Specialty oral solid dose brands - Oral solution brands - Injectable brands - Transdermal brands THE AUTHORIZED GENERICS OUTLOOK Closing the Hatch-Waxman loophole Reverse-payment scrutiny should not impact on authorized generics use Own authorized generics use set to grow Emergence of novel late-stage lifecycle management strategies - Risk management plans hold up generic approvals - Generics in transit fall prey to customs regulations

5 Table of contents (continued) BIBLIOGRAPHY Publications and online articles Company press releases Datamonitor reports APPENDIX Authorized generics agreements Exchange rates About Datamonitor - About Datamonitor Healthcare Datamonitor consulting Disclaimer LIST OF TABLES Table 1: Authorized generic agreements in the US, Table 2: Currency exchange rates, 2008 LIST OF FIGURES Figure 1: Final settlement agreements which included AG provisions in the US, fiscal years Figure 2: Key drivers and resistors for authorized generic agreements Figure 3: Authorized generic agreements in the US, Figure 4: Authorized generic agreements in the US between 2004 and 2008 Figure 5: Correlation between number of generic entrants and branded market size in the 2 years following generic market entry in the US, Figure 6: Authorized generic volume market share dynamics by brand value in the US, Figure 7: Generic erosion of brands with pre-generic quarterly sales of less than $100m in the 2 years following generic market entry in the US, Figure 8: Generic erosion of brands with pre-generic quarterly sales of $ m in the 2 years following generic market entry in the US, Figure 9: Generic erosion of brands with pre-generic quarterly sales of $ m in the 2 years following generic market entry in the US, Figure 10: Generic erosion of brands with pre-generic quarterly sales of $ m in the 2 years following generic market entry in the US, Figure 11: Generic erosion of brands with pre-generic quarterly sales of more than $600m in the 2 years following generic market entry in the US, Figure 12: Authorized generic agreements by therapeutic class, Figure 13: Authorized generic volume market share dynamics across therapeutic classes in the US, Figure 14: Generic erosion of cardiovascular brands in the 2 years following generic market entry in the US, Figure 15: Generic erosion of infectious disease brands in the US in the 2 years following generic market entry in the US, Figure 16: Generic erosion of central nervous system brands in the US in the 2 years following generic market entry in the US, Figure 17: Generic erosion of endocrine and metabolic disease brands in the US in the 2 years following generic market entry in the US, Figure 18: Generic erosion of oncology brands in the US in the 2 years following generic market entry in the US, Figure 19: Generic erosion of immune and inflammatory disease brands in the 2 years following generic market entry in the US, Figure 20: Generic erosion of genitourinary disease brands in the 2 Figure 21: Generic erosion of respiratory disease brands in the US in the 2 years following generic market entry in the US, Figure 22: Authorized generic agreements by dosage form in the US, Figure 23: Authorized generic volume market share dynamics by dosage form in the US, Figure 24: Generic erosion of standard oral solid dose brands in the 2 Figure 25: Generic erosion of specialty oral solid dose brands in the 2 Figure 26: Generic erosion for branded oral solution products in the 2 Figure 27: Generic erosion of injectable brands in the 2 years following generic market entry in the US, Figure 28: Generic erosion for transdermal brands in the 2 years following generic market entry in the US, Figure 29: The pathway to generic approval in the US Figure 30: Brand lifecycle management strategies

6 Interested in this topic? Datamonitor s 21st Century Insight portfolio provides access to detailed research and analysis on a comprehensive range of strategic issues within the global pharmaceutical industry, with actionable recommendations to support your strategic decision-making. Sales and Marketing R&D and Licensing Pricing and Pharmacoeconomics Business Development Other reports in this series Future Pharmaceutical Industry Trends: Long-Term Opportunities Tempered By Short-Term Challenges An overview of the key trends shaping the pharmaceutical industry today, and those that are set to play a central role in the future, as companies transition towards a new business model: Pharma 2.0. Published: Apr-09 Code: DMHC2497 Generic Benchmarking: Brand Erosion at Patent Expiry Case study and trend analysis of branded sales and volume erosion of pharmaceutical products by generics in the US, Japan and 5EU markets (France, Germany, Italy, Spain and UK), following patent expiry. Published: Mar-09 Code: DMHC2496 Generics Series: Generics Trends in the Seven Major Markets and Beyond The global generics market is growing, however competitive pressures in the more mature markets, and challenging market conditions in immature ones, are pushing industry players to adopt novel and more aggressive strategies to sustain growth. Published: Dec-08 Code: DMHC2468 Trends in Pharmaceutical Portfolio Management: Strategies to Maintain Profitability despite Adversity Analysis of the current trends in pharmaceutical portfolio management with a focus on the interaction between marketed and R&D portfolios, and creation of additional value through portfolio synergies within a given therapeutic area. Published: Sep-08 Code: DMHC2449 For more information about these products or to browse and purchase from our huge range of research please visit. Contact our customer service team today... Europe tel: fax: Americas tel: fax: Middle East tel: fax: Asia Pacific tel: fax:

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