 |
Printer Friendly
Printed from http://www.researchandmarkets.com/reports/1071231
Emerging Opportunities in Controlled-Release Generic Drugs
|
Description: |
This new report identifies 30 controlled-release drugs valued at US$15 billion, many of which will be losing patent protection in the medium term.
From emerging specialist companies to established generic producers, alternative drug delivery technologies are increasingly being seen as a route to a competitive edge in the generics industry.
While controlled-release products have traditionally been developed towards the patent-expiry, companies are now beginning to look at controlled-release delivery earlier in the product life-cycle and, in some cases, are launching immediate- and controlled-release versions of new drugs to address the differing needs of patients.
A number of significant controlled-release drugs some of them blockbusters will lose patent protection in the medium term. This has led to increased interest from a range of companies vying for a share of the controlled-release generics market.
Fewer competitors, higher margins:
It’s an attractive area: due to the significant technical barriers to the development of controlled-release drugs, they will generally have fewer competitors in the marketplace and, therefore, will attract higher prices and greater revenue opportunities than the highly competitive instant-release formulations.
A US$15 billion sector:
The controlled-release drugs reviewed in this report had combined sales of more than US$15 billion in 2008. While the majority of these have patent protection for the controlled-release formulation, the validity of these patents is often the subject of litigation, particularly in the US where companies frequently file Paragraph IV certifications under the Hatch-Waxman act. In some cases, these legal challenges result in agreements between generic companies and originators, allowing the limited introduction of generics some years prior to patent expiry.
Identify key product opportunities, patent status and the activities of companies competing across all delivery platforms in this rapidly-developing growth area with this new 125+ page report:
- Assess the current position and future potential of 30 CR therapies in key therapy areas
- Evaluate the activities of 13 companies active in the field
- Review the sector's position in the context of the broader generic market |
|
Contents: |
FOREWORD
EXECUTIVE SUMMARY
OVERVIEW
- Leading Generic Markets
- Controlled-Release Delivery Technology
- Delivery Platforms
- Controlled-Release Drugs
- FDA Approved Generics
CARDIOVASCULAR
- Lescol XL (fluvastatin)
- Patents & Exclusivity
- Generic Company Activity
- Advicor (lovastatin+niacin)
- Patents
- Generic Company Activity
- Coreg CR (carvedilol phosphate)
- Patents & Exclusivity
- Generic Company Activity
- Cardizem LA (diltiazem)
- Patents
- Generic Company Activity
- Seloken/Toprol-XL (metoprolol succinate)
- Generics
- Orbus Pharma
- Adalat CC (nifedipine)
- Patents
- Generic Company Activity
- Tarka (trandolapril+verapamil)
- Patents
- Generic Company Activity
- Aggrenox (dypyridamole+acetylsalicylic acid)
- Patents
- Generic Company Activity
CNS
- Concerta (methylphenidate)
- Patents
- Generic Company Activity
- Andrx (Watson)
- Impax
- Metadate CD / Equasym XL (methylphenidate)
- Patents
- Generic Company Activity
- Ritalin LA (methylphenidate)
- Patents
- Generic Company Activity
- Focalin XR (dexmethylphenidate)
- Patents
- Generic Company Activity
- Adderall XR (mixed amphetamine salts)
- Patents
- Generic Company Activity
- Barr & Teva
- Impax
- Actavis & Colony Pharmaceuticals
- Sandoz
- Andrx
- Carbatrol (carbamazepine)
- Patents
- Generic Company Activity
- Impax
- Nostrum
- CorePharma
- Teva
- Apotex
- Actavis
- Equetro (carbamazepine)
- Patents
- Generic Company Activity
- Tegretol XR (carbamazepine)
- Patents
- Generic Company Activity
- Seroquel XR (quetiapine)
- Patents & Exclusivity
- Generic Company Activity
- Amrix (cyclobenzaprine)
- Patents & Exclusivity
- Generic Company Activity
- Avinza (morphine)
- Patents
- Generic Company Activity
- OxyContin (oxycodone)
- Patents
- Generic Company Activity
- KV Pharmaceutical Company
- Mallinckrodt
- Impax Laboratories
- Teva Pharmaceutical Industries
- Endo Pharmaceuticals
- Opana ER (oxymorphone)
- Patents
- Generic Company Activity
- Impax
- Actavis
- Barr (Teva)
- Ultram ER (tramadol)
- Patents
- Generic Company Activity
- Cipher Pharmaceuticals
- Impax
- Effexor XR (venlafaxine)
- Patents
- Generic Company Activity
- Osmotica
- Lupin
- Cadila Healthcare
- Torrent Pharmaceuticals
- Sun Pharma
- Anchen Pharmaceuticals
- Mylan
- Apotex
- Biovail
- Impax
- Teva Pharmaceutical Industries
- Ambien CR (zolpidem tartrate)
- Patents
- Generic Company Activity
- Requip XL (ropinirole)
- Patents & Exclusivity
- Generic Company Activity
OTHERS
- Xatral/Uroxatral (alfuzosin)
- Patents
- Generic Company Activity
- Oxytrol (oxybutynin)
- Patents
- Generic Company Activity
- Detrol LA (tolterodine)
- Patents
- Generic Company Activity
- Sanctura XR (trospium chloride)
- Patents & Exclusivity
- Generic Company Activity
- Augmentin XR (amoxicillin+clavulanic acid)
- Patents
COMPANY PROFILES
- Actavis
- CR/ER Products
- Patent Litigation & Agreements
- Oxymorphone litigation settled
- Acquisitions
- Actavis strengthens its position in India
- Actavis acquires Abrika
- Actavis acquires Alpharma’s Human Generics business
- Financials
- Handa Pharmaceuticals
- Seroquel XR Litigation
- Impax Laboratories
- Products
- R&D
- Patent Litigation & Agreements
- Suit filed as Impax submits ANDA for generic Amrix
- Lawsuit for infringement of Renvela patents
- Lawsuit for infringement of Doryx patent
- Agreement with Teva
- Financials
- KV Pharmaceutical
- CR/ER Products
- Patent Litigation Agreement
- KV settles oxycodone litigation with Purdue Pharma
- Financials
- Mallinckrodt
- CR/ER Products
- Mylan
- Products
- Patent Litigation
- Amrix
- Effexor XR
- Uroxatral
- Acquisitions
- Merck Generics Acquisition
- Matrix Laboratories Acquisition
- Financials
- Par Pharmaceutical
- CR/ER Products
- Patent Litigation
- Par and Reliant settle propafenone litigation
- Litigation relating to tramadol extended-release tablets
- Agreements
- AstraZeneca/Par enter agreement for generic version of Toprol-XL
- IntelliPharmaCeutics announces equity investment by Par Pharmaceutical
- Agreement with Abrika (Actavis)
- Financials
- Sun Pharma
- CR/ER Products
- Financials
- Taro Pharmaceutical Industries
- CR/ER Products
- Financials
- Teva Pharmaceutical Industries
- Products
- Patent Litigation & Agreements
- Teva Launches Generic Adderall XR
- Watson files patent lawsuit against Barr for Oxytrol
- Aggrenox Litigation Settlement with Boehringer Ingelheim
- Barr and Kos Settle Advicor Patent Litigation
- Amrix Patent Infringement Lawsuit
- Focalin XR Patent Litigation
- Ritalin LA Patent Litigation
- OxyContin Settlement
- Effexor XR Agreement
- Major Developments
- Teva acquires Barr
- Financials
- URL Pharma
- CR/ER Products
- Watson Pharmaceuticals
- CR/ER Products
- Patent Litigation
- Watson files ANDA for generic Sanctura XR; Allergan files lawsuit
- Watson files Mucinex D ANDA; Reckitt Benckiser files lawsuit
- Watson files ANDA for generic Enablex; Novartis files lawsuit
- Andrx gains methylphenidate court victory
- Acquisition
- Watson completes acquisition of Andrx
- Financials
- Zydus Cadila
- CR/ER Products
- Financials
- Major Developments
- Etna Biotech Acquisition
- Majority stake in Simayla Pharmaceuticals
- Laboratorios Combix Acquisition
SOURCES
- Espicom Sources
- Others
LIST OF TABLES:
Controlled-Release Drug Sales, 2008 (US$ Million)
Controlled-Release Drugs by Therapy Area
Controlled-Release Drugs by US Patent Expiry
FDA ANDA Approval for Extended-Release Drugs, 2005-2009 (30th June)
Lescol XL US Patents
Advicor US Patents
Coreg CR Sales, 2007-2008 (£ & US$ Million)
Coreg CR US Patents
Cardizem US Patents
Seloken ZOK/Toprol-XL Sales, 2004-2008 (US$ Million)
FDA ANDA Approvals for Metoprolol Succinate
Adalat CC Sales, 2004-2008 (EUR & US$ Million)
Adalat CC US Patents
FDA ANDA Approvals for Nifedipine Extended-Release Tablets
Tarka US Patents
Aggrenox Sales, 2004-2008 (EUR & US$ Million)
Aggrenox US Patents
Concerta US Patents
Metadate CD US Patents
Ritalin LA US Patents
Focalin XR US Patents
Adderall XR US Patents
Carbatrol US Patents
Equetra US Patents
Tegretol US Patent
Seroquel XR US Patents
Amrix US Patents
Avinza US Patent
OxyContin US Patents
Opana ER US Patents
Ultram ER US Patents
Effexor XR US Patents
Ambien CR US Patent
Requip XL Sales, 2008 (£ & US$ Million)
Requip XL US Patents
Xatral/Uroxatral Sales, 2004-2008 (EUR & US$ Million)
Uroxatral US Patents
Tentative ANDA Approvals for 10mg Alfuzosin Hydrochloride ER Tablets
Oxytrol US Patents
Detrol LA US Patents
Sanctura Sales, 2007-2008 (US$ Million)
Sanctura XR US Patents
Augmentin XR US Patents
Actavis ANDA Approvals for CR/ER Products, 2006-2009
Actavis Financial Results, 2003-2006 (EUR & US$ Million)
Impax Laboratories ANDA Approvals for ER Products, 2004-2009
Impax Financial Results, 2004-2008 (US$ Million)
KV Pharmaceutical ANDA Approvals for CR/ER Products, 2004-2009
KV Pharmaceutical Financial Results, 2004-2008 (US$ Million)
Mallinckrodt ANDA Approvals for CR/ER Products, 2003-2009
Mylan ANDA Approvals for CR/ER Products, 2002-2009
Mylan Financial Results, 2004-2008 (US$ Million)
Par Pharmaceutical Financial Results 2004-08 (US$ Million)
Sun Pharma ANDA Approvals for CR/ER Products
Sun Pharma: Financial Results, 2004-2008
Taro ANDA Approvals for CR/ER Products
Taro Pharmaceutical Industries restatements for 2004 and 2005 (US$000s)
Teva ANDA Approvals for CR/ER Products, 2002-2009
Barr ANDA Approvals for CR/ER Products, 2002-2009
Teva Financial Results, 2004-2008 (US$ Millions)
URL Pharma ANDA Approvals for ER Products, 2004-2009
Watson ANDA Approvals for CR/ER Products, 2002-2009
Andrx ANDA Approvals for CR/ER Products, 2002-2009
Watson Financial Results, 2004-2008 (US$ Million)
Zydus ANDA Approvals for CR/ER Products, 2005-2009
Zydus Tentative ANDA Approval for CR/ER Product
Zydus Cadila Financial Results, 2005-2009
LIST OF FIGURES:
Generic Pharmaceutical Expenditure, 2008 (US$ Billions)
Generic Pharmaceutical Expenditure per capita, 2008 (US$)
Generic Pharmaceutical Expenditure as % of Total, 2008
FDA ANDA Approvals by Therapy Area 2005-2009
FDA ANDA Approvals by Therapy Area 2005-2009 (%)
FDA ANDA Approvals by Company, 2005-2009 |
|
Companies Mentioned |
Companies Assessed:
- Actavis
- Handa Pharmaceuticals
- Impax Laboratories
- KV Pharmaceutical
- Mallinkrodt
- Mylan
- Par Pharmaceutical
- Sun Pharma
- Taro Pharmaceutical Industries
- Teva Pharmaceutical Industries
- URL Pharma
- Watson Pharmaceutical
- Zydus Cadila
Product Assessed:
Cardiovascular
- Lescol XL (fluvastatin)
- Advicor (lovastatin+niacin)
- Coreg CR (carvedilol phosphate)
- Cardizem LA (diltiazem)
- Seloken/Toprol-XL (metoprolol succinate)
- Adalat CC (nifedipine)
- Tarka (trandolapril+verapamil)
- Aggrenox (dypyridamole+ acetylsalicylic acid)
CNS
- Concerta (methylphenidate)
- Metadate CD, Equasym XL (methylphenidate)
- Ritalin LA (methylphenidate)
- Focalin XR (dexmethylphenidate)
- Adderall XR (mixed amphetamine salts)
- Carbatrol (carbamazepine)
- Equetro (carbamazepine)
- Tegretol XR (carbamazepine)
- Seroquel XR (quetiapine fumarate)
- Amrix (cyclobenzaprine)
- Avinza (morphine)
- OxyContin (oxycodone)
- Opana ER (oxymorphone hydrochloride)
- Ultram ER (tramadol)
- Effexor XR (venlafaxine)
- Ambien CR (zolpidem tartrate)
- Requip XL (ropinirole)
Genito-urinary
- Xatral/Uroxatral (alfuzosin)
- Oxytrol (oxybutynin)
- Detrol LA (tolterodine)
- Sanctura XR (trospium chloride)
Antibiotics
- Augmentin XR (amoxicillin+clavulanic acid) |
|
Ordering: |
Order Online - visit http://www.researchandmarkets.com/reports/1071231
Order by Fax - using the order form below
Order By Post - print the order form below and send to
|
|
Research and Markets,
Guinness Centre,
Taylors Lane,
Dublin 8,
Ireland.
|
|
|
 |
Page 1 of 2
Printed 24/11/2009 13:34:15 |
|
Fax Order Form
To place an order via fax simply print this form, fill in the information below and
fax the completed form to
646-607-1907 (from USA) or +353 1 6849977 (from Rest of World). If you have any questions please email help@researchandmarkets.net
Order information
Please verify that the product information is correct and select the format you require.
|
|
|
|
Product Name: |
Emerging Opportunities in Controlled-Release Generic Drugs
|
|
Web Address: |
http://www.researchandmarkets.com/reports/1071231
|
|
Office Code: |
|
OC8HJMSMOVUUX
|
Report formats
Please enter the quantity of the report format you require.
|
|
Format
|
Quantity
|
Price
|
|
Electronic (PDF)
- Single User
|
|
€1,495.00
|
|
Hard Copy
|
|
€1,495.00 + EUR€ 50.00 Shipping/Handling *
|
|
Electronic (Online Access)
|
|
€1,495.00
|
* Shipping/Handling is only charged once per order.
Contact information
Please enter all the information below in BLOCK CAPITALS.
|
|
|
First Name: |
Last Name: |
|
Email Address: |
|
|
Job Title: |
|
|
Organisation: |
|
|
Address: |
|
|
City: |
|
|
Postal/Zip Code: |
|
|
Country: |
|
|
Phone Number: |
|
|
Fax Number: |
|
|
Please fax this form to:
(646) 607-1907 or (646) 964-6609 (from USA)
+353-1-481-1716 or +353-1-653-1571 (from Rest of World)
|
|
Page 2 of 2
Printed 24/11/2009 13:34:15
|
|
Payment information
Please indicate the payment method you would like to use by selecting the appropriate
box.
|
|
|
|
|
American Express
|
|
|
Diners Club
|
|
|
Master Card
|
|
|
Visa
|
|
|
|
|
|
|
Cardholder's Name: |
|
|
|
|
Cardholder's Signature: |
|
|
|
|
Expiry Date: |
/ |
|
|
|
Card Number: |
|
|
|
|
CVV Security Code: |
|
|
|
|
Issue Date: |
/ (Diners
Club only)
|
|
|
|
|
|
|
Please post the check, accompanied by this form, to:
Research and Markets,
Guinness Centre,
Taylors Lane,
Dublin 8,
Ireland.
|
|
|
|
|
|
|
Please transfer funds to:
|
|
|
Account number: |
83313083 |
|
Sort code: |
98-53-30 |
|
Swift code: |
ULSBIE2D |
|
IBAN number: |
IE78ULSB98533083313083 |
|
Bank Address: |
Ulster Bank,
27-35 Main St,
Blackrock,
Co. Dublin,
Ireland. |
|
|
|
If you have a Marketing Code please enter it below:
|
|
|
Marketing Code: |
|
|
Please note that by ordering from Research and Markets you are agreeing to our Terms and Conditions at http://www.researchandmarkets.com/info/terms.asp
|
|
Please fax this form to:
(646) 607-1907 or (646) 964-6609 (from USA)
+353-1-481-1716 or +353-1-653-1571 (from Rest of World)
|
|
|
|
|
|
