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CHAPTER 4: DEFENSIVE STRATEGIES Summary Introduction Patent infringement suits - Mechanism Authorized generics OTC switches Orange Book delisting Research Disclosures CHAPTER 5: CASE HISTORIES Summary Introduction Prozac Losec and Nexium Epogen v Dynepo Plavix - Legal challenges - Impact of generic clopidogrel CHAPTER 6: OPTIMIZING REVENUE RETURNS Summary Introduction Lifecycle initiatives Franchise development - Follow on products - Secondary patents - Prodrugs Portfolio development Competing with generics CHAPTER 7: FUTURE OUTLOOK Summary Introduction Changes in drug development - Impact of technology - Tougher project goals Legislative issues - KSR International Co. v. Teleflex Inc US Supreme Court ; Biologicals FIGURES Novel Therapeutic Entities Approved by the FDA, 2000-2006 Schematic drug revenue life cycle Dependence of major companies' 2006 revenues on blockbuster products US Sales of Prozac and generic fluoxetine, 2000 2006 Quarterly US sales of Zocor 2005-2006 Quarterly US sales of Plavix 2005-2007 US sales of OTC and Prescription Claritin, 20002006 Variation in number of SPCs granted in EU countries, 2003 Variation in number of SPCs granted in EU countries, 2003 Impact of offensive strategies on drug revenue life cycle Primary claims of two key patents relating to paroxetine Impact of defensive strategies on drug revenue life cycle Timeline of from Paragraph IV ANDA filing US sales of Paxil, an authorized generic and a competing generic August 2003- June 2004 US Sales revenues of Schering-Plough's major anti-histamines 2000-2006 Revenues from AstraZeneca's antiulcer franchise 1999-2006 US Sales of Wellbutrin and generic bupropion 19992006 Global sales of Adalat formulations 1975-2000 TABLES Drugs generating 2006 revenues in excess of $3 billion Possible term extensions in major markets Selected high revenue generating Orphan drugs Orphan drug legislation in the major markets Amgen's key Epogen patents and plavix. 1.CBT is an effective treatment for social phobia. It is at least as effective as medications in the short-term and may be more effective in the long-term. Intervention packages combining cognitive restructuring techniques and exposure exercises have become the psychosocial treatments of choice. 2. See Appendix B for Glossary of CBT Terms. 503.2 ENROLLMENT: PHYSICIAN ASSISTANT Physician assistants cannot be enrolled as direct Medicaid providers. However, WV Medicaid allows enrolled physicians to bill for covered services rendered to Medicaid members by physician assistants in their employ and or under their supervision. Supervising physicians must follow the regulations established in WV Code 30-3-1 et seq. Physicians are not required to be physically present on the premises in order to bill for physician assistant services performed under their supervision and plendil.

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Background and Purpose: Current development of stroke centers is the result of local interest Background and Purpose: Depression is common after stroke, but only little is known about and market forces - potentially leading to inadequate or excessive resources for a given area. depression as a risk factor for vascular disease. The aim of this study was to analyze Geographic Information System GIS ; modeling allows identification of hospitals for developdepression disorder as a potential risk factor for the development of later cerebrovascular ment to provide uniform population and geographic coverage. The purpose of this study was disease. We therefore examined the prevalence of depression at age 85 and its relation to the to identify the minimum number of hospitals required to provide stroke center coverage to 95% incidence of stroke and dementia in a representative sample of 494 85-year olds living in of the eligible Michigan population. Methods: All acute-care hospitals were identified from the Gothenburg Sweden. Methods: Information of depression was derived from a psychiatric Michigan Hospital Association and geocoded with US census YR 2000 ; block point data. examination at age 85 in accordance with the Comprehensive Psychopathological Rating Scale Assuming a 3-hour treatment window, the model allowed 1-hour each for patient recognition; CRPS ; . Information of stroke was obtained from a hospital linkage system, death certificates, transport; and ED evaluation and treatment. Standard EMS transport distances of 20 miles were self-reports and relatives in a three year follow-up period. Information of dementia after 3 years used to determine the population within 1 hour of all 147 hospitals, establishing the maximum was derived from psychiatric interviews with self-reports and relatives, the diagnosis was made population with access to a potential stroke center. To identify the minimum number of stroke according to the Diagnostic and Statistical Manual of Mental Disorders, 3rd revision. Results: centers needed, each Metropolitan Statistical Area MSA, n 10 ; was evaluated separately The prevalence of depression at age 85 was 16.1%. The hazard ratio for stroke in those with along with Urban Areas with 45, 000 persons to adjust for concentration of facilities. Within depression was 2.2 95%-CI 1.0 ; compared to those without. This was only true in women an MSA, each hospital was added to the GIS model in rank order of unique population coverage HR 2.7, 95%-CI 1.2 ; , but not in men HR 0.7, 95%-CI 0.1 ; . In women with depression then total population coverage until 95% of the covered population for each MSA had at age 85 the hazard ratio for vascular dementia was 3.2 compared to those without 90.0 1000 access. Results: A total of 147 hospitals were identified. Developing all facilities as stroke vs. 28.7 1000 person years, HR 3.2, 95%-CI 1.19.7 ; . Conclusion: Depression is associated centers provided access to 9, 847, 908 individuals within a 20 mile radius 99.1% of total state with a higher frequency of stroke in this three year follow-up period. Women with depression population ; . GIS-based hospital selection allowed coverage of 9, 578, 964 persons 97.3% of seem to be at higher risk for stroke. In addition depression has clinical consequences, eligible population, 96.4% of total state pop ; using only 81 hospitals 55% of all hospitals ; . increasing the risk for vascular dementia in women more than three times. It has to be Conclusions: The vast majority of MI resident have access to a potential stroke center. Use of evaluated whether consequent antidepressive treatment will reduce the subsequent risk of GIS modeling to identify hospitals for stroke center development based on geographic and Downloaded from stroke.ahajournals by on September 20, 2007 reduce the total number of facilities required population considerations can substantially stroke and dementia in further studies, for instance, prescription drugs.
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71 ; TAISHO PHARMACEUTICAL CO., LTD. [JP JP]; 241, Takata 3chome, Toshimaku, Tokyo 1708633 JP ; . for all designated States except pour tous les tats dsigns sauf US ; 72, 75 ; NAGAHAMA, Tohru [JP JP]; Taisho Pharmaceutical Co., Ltd., 241, Takata 3chome, Toshimaku, Tokyo 1708633 JP ; . HASEGAWA, Kazuo [JP JP]; Taisho Pharmaceutical Co., Ltd., 241, Takata 3chome, Toshimaku, Tokyo 1708633 JP ; . 74 ; KITAGAWA, Tomizo; Taisho Pharmaceutical Co., Ltd., Patent Division, 241, Takata 3chome, Toshimaku, Tokyo 1708633 JP ; . 81 ; US; EP AT BE CH. Remove: "Reminder: Element-specific notes and guidelines should take precedence over the General Abstraction Guidelines e.g., Initial ECG Interpretation ; ." From Qualifiers and Modifiers Table 2.6 Add to discharge status code 01: Home with Hospice referral only has not accepted hospice care by a hospice organization Home with outpatient therapy OT PT ; not provided by a home health service organization Add to discharge status code 03: Skilled nursing facility with hospice referral only has not accepted hospice care by a hospice organization ; Add to discharge status code 04: Nursing facility with hospice referral only has not accepted hospice care by a hospice organization and prempro.
Gerald B. Appel, MD Professor of Clinical Medicine Columbia University College of Physicians and Surgeons Director of Clinical Nephrology Columbia Presbyterian Medical Center New York, New York John M. Flack, MD, MPH Professor and Associate Chairman for Academic Affairs and Chief Quality Officer Director, Cardiovascular Epidemiology and Clinical Applications Program Department of Internal Medicine Wayne State University School of Medicine Detroit, Michigan Richard H. Grimm, Jr, MD, PhD, MPH Professor of Cardiology and Epidemiology Berman Center for Outcomes and Clinical Research Chief, Division of Clinical Epidemiology Hennepin County Medical Center Minneapolis, Minnesota Faculty Disclosure.

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