CNS Generic Drugs: Prospects and Opportunities to 2012

Countries covered: United States This important new strategic report from Espicom evaluates the CNS generic drug market and provides detailed assessment and forecast for leading products by value to 2012, patent expiry opportunities to 2015 and competitive evaluation. Providing… Detailed assessment and forecast for leading products by value to 2012 and beyond An assessment of patent expiry and challenges Competitive evaluation A review of products in late phase research which could impact generic developments Patent expiry opportunities to 2015 All major sectors Neurodegenerative Diseases (Alzheimer’s and Parkinson’s Diseases) Depression Multiple Sclerosis ADHD Insomnia Sales of the leading branded drugs used to treat the major CNS conditions could exceed US$70 billion in 2008, with a number of these losing patent protection in the coming years. This important new strategic report evaluates the CNS generic drug market sector and answers key questions such as: What is the patent and data exclusivity status of Shire’s ADHD drug Adderall? What impact on sales of GSK’s Seroxat/Paxil will generic competition have from 2007? What opportunities exist for Wyeth’s valuable SSNRI Effexor? What strategies are sanofi-aventis employing in defence of its best selling insomnia treatment Ambien? Only Exelon is currently available generically for the treatment of Alzheimer’s - what is the potential of the other leading treatments Aricept (Eisai), Razadyne (Janssen) and Namenda (Forest Labs)? What’s in the pipeline? New branded products that will compete with generics in the future. Why will sales of Eli Lilly’s Zyprexa remain constant over the next 5 years despite rising generic availability? What are Dr Reddy’s CNS drug interests? In 2007, Caraco Pharmaceuticals received 3 ANDA approvals for CNS drugs. What were they and in what dosages?

Additional Information

One of the fastest growing drug sectors in terms of product and market value, CNS presents the generics industry with much needed on-going product opportunities

ANTIDEPRESSANTS
Antidepressant sales in 2005 were approximately US$16.2 billion, and accounted for around 25% of the total CNS market. Global sales of the depression drugs analysed in this report in 2006 were worth some US$11.5 billion, with the largest selling, Effexor (venlafaxine), seeing sales worth US$3.7 billion. However, Effexor is now open to generic competition in the United States, with Teva having had an ANDA approved in 2006, and so it is likely that sales of the branded version will decline.

SCHIZOPHRENIA
Sales of schizophrenia drugs in 2005 were worth some US$15.5 billion, accounting for 23% of global CNS sales, making the segment the second largest CNS category. Global sales in 2006 of the schizophrenia drugs listed in this report were worth US$9.7 billion, with Zyprexa (olanzapine) and Risperdal (risperidone) accounting for US$4.4 billion and US$4.2 billion of this, respectively. Currently there are no generic equivalents to any of the schizophrenia drugs listed in the report in the US. However, a number of ANDAs for generic versions of Zyprexa and Risperdal have been tentatively approved.

NEURODEGENERATION
(ALZHEIMER’S DISEASE & PARKINSON’S DISEASE)
The neurodegenerative disorders segment is divided into two components, drugs for treating Alzheimer’s disease, and drugs for treating Parkinson’s disease. In 2005, some US$6.8 billion was spent on treatments for these two conditions, despite the fact that they only affect around 1% of the world’s population. In 2006, global sales of the five Alzheimer’s disease drugs listed in this report were worth some US$1.6 billion, whilst those for treating Parkinson’s disease were worth some US$1.5 billion.

MULTIPLE SCLEROSIS
The multiple sclerosis market was estimated to be worth some US$$4.8 billion in 2005. Global sales of the MS drugs listed in this report in 2006 were worth some US$5.8 billion. Of these, only one, Novantrone (mitoxantrone), is currently subject to generic competition in the US.

ADHD
The ADHD market had global sales of US$2.6 billion in 2005, and accounted for 3.8% of global CNS sales. Global sales for the drugs listed in this report were worth over US$2.8 billion, with the largest selling, Concerta (methylphenidate), having sales worth US$930 million.

INSOMNIA
The global market for insomnia products in 2005 was worth US$2.4 billion, and accounted for 3.5% of global CNS sales. In 2006, global sales for Ambien (zolpidem) were worth some US$2.7 billion. However, zolpidem has now been opened to generic competition in the US, with a number of companies gaining ANDA approvals for versions of the drug in 2007.

Among the 63 products evaluated in the report
Abilify
Aricept
Azilect
Carbatrol
Copaxone
Cymbalta
Durotep
Effexor
Exelon
Invega
Keppra
Lamictal
Lyrica
Namenda
Prozac
Rebif
ReQuip
Risperdal
Seroxat
Zoloft
Zyprexa

Companies active in the CNS market are reviewed with respect to
CNS Products
Recent Product Approvals
Financials
Significant developments

Companies covered:
Apotex
Aurobindo Pharma
Barr Pharmaceuticals
Bedford Laboratories
Caraco Pharmaceutical Labs
Dr Reddy’s Laboratories
Impax Laboratories
Interpharm
KV Pharmaceutical
Mallinckrodt
Mikart
Mylan
Perrigo
Ranbaxy Laboratories
Roxane Laboratories
Sandoz
Sun Pharmaceutical Industries
Teva Pharmaceutical Industries
United Research Laboratories/Mutual Pharmaceutical Company
Watson Pharmaceuticals

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