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Innovative Drug Delivery Systems Opportunities for Generic & Specialty Pharmaceutical Companies

出版商 MP Advisors 商品編碼 296610
出版日期 內容資訊 英文 91 Pages
商品交期: 最快1-2個工作天內
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非專利&特殊醫藥品企業的創新的藥物遞輸系統的機會 Innovative Drug Delivery Systems Opportunities for Generic & Specialty Pharmaceutical Companies
出版日期: 2014年02月25日 內容資訊: 英文 91 Pages



第1章 全球學名藥商務:現狀、未來的機會

第2章 近幾年契約為基礎的先進藥物遞輸系統的治療焦點與趨勢

第3章 專利失效的影響、學名藥企業的策略:超級學名藥

第4章 製劑的溶度和滲透性的關係

第5章 非水溶性醫藥品、口服肽遞輸的製劑方法

第6章 FDA的505 (b)(2)解決方案指南及開發的優點

第7章 505 (b)(2)由開發而得到許可的變更類型與其優點

第8章 505 (b)(2)開發臨床資料必要條件的法規的課題與安全性的研究

第9章 來自口服、注射製劑的100個以上的製劑設計議論的75家以上醫藥品企業的製劑技術分析、應用及優點

第10章 受議論的特殊醫藥品企業的後期階段開發平台開發

第11章 受議論的製劑專利技術

Product Code: TC14022402

The oral drug delivery market remains the largest slice of the overall drug delivery market, with more than 52% of the market share. It is presently valued at $49 billion and is expected to reach over $90 billion by 2016, at a CAGR of 11%. The growth in the oral drug delivery market shall be driven primarily by newer technologies enabling controlled release formulations of oral drugs and oral formulations of injectable only drugs. Global injectable drug delivery market is expected to be worth $29b by 2015.

Novel drug delivery systems (NDDS) offers many more advantages, which include improved therapy by increasing the efficacy and duration of drug activity, increased patient compliance through decreased dosing frequency and convenient routes of administration and improved targeting for a specific site to reduce unwanted side effects. The challenge for both drug and drug delivery companies is to deliver both existing and emerging drug technologies in a manner that improves the benefits to the patients.

The generic market with reference to innovative molecule (NCE) has become very competitive as several companies have already filed the ANDA for the potential generic drugs in the near term. The study of novel drug delivery companies and their formulation technologies will provide the potential value added opportunity in the generic field in terms of patient's compliance or bioavailability enhancement. It will also provide enhanced life cycle for the drugs under patent coverage (life cycle extension).

This comprehensive report on novel drug delivery system focused mainly on oral and injectable formulations for the pharma and specialty companies. This report enumerates the various formulation technology involved in making value added formulations, pharmaceutical applications and advantages of the specific technology. Wherever available, the marketed drugs using the similar technology as the proof of validation and the status of additional pipeline have also been discussed. The discussed proprietary formulations technologies includes Colal, Glide SDI, Arestat, GeoClock, GeoMatrix, FlashTab, Lock Tab, Medusa, Eligen, Oradur, EnteriCare and Saber.

This report will be helpful for the pharma companies exploring novel opportunities for their growth by in-licensing the formulation technology or value added pipeline drugs available/being studied in the market.

Table of Contents

  • 1. Global Generic Business - Present Status and Future Opportunities
  • 2. Therapeutic focus and Trends in Advanced drug Delivery System based on recent deals
  • 3. Patent expiry impact and generic companies strategies -Super generics
  • 4. The relationship between solubility and permeability in formulations
  • 5. Formulation approach for water -insoluble drugs and oral peptide delivery
  • 6. FDA guidelines for 505 (b)(2) applications and advantage of development
  • 7. Types of changes allowed in 505 (b)(2) development and its advantage
  • 8. Regulatory challenges in clinical data requirement in 505(b)(2) development and safety studies
  • 9. Analysis, Application and Advantages of formulations technologies for more than 75 pharma companies with over 100 formulation technologies in oral and injectable formulations discussed
  • 10. Late stage pipeline development for discussed specialty Pharma companies
  • 11. The discussed formulations proprietary technologies includes Colal, Glide SDI, Arestat, GeoClock, GeoMatrix, FlashTab, Lock Tab, Medusa, Eligen, Oradur, EnteriCare and Saber

Key Charts and Tables

  • Chart -1 : Global revenue of Advanced Drug Delivery Systems by region, 2009-16 ($millions)
  • Chart-2 : Utilization of generic medicines within the unprotected markets
  • Chart - 3 : Generic spending per capita (US$) in 2011 and 2016
  • Chart - 4 : Trends in Drug Delivery Deals - stages of development in 2012
  • Chart - 5 : The current trends in Drug Delivery Deals By technology - 2012
  • Chart - 6 : Oral Drug Delivery Market, Marketed Oral Small Molecules by Therapy Area, %, 2011
  • Chart -7 : Relationship between solubility and GI permeability
  • Chart - 8 : Solubility and GI Permeability -Biopharmaceutical Classification Scheme (BCS)
  • Chart - 9 : FDA approval statistics for 505(b)(2) pathway -1996-2011
  • Table -1 : Formulation approaches for Water-Insoluble drugs
  • Table -2 : Ingredients Used for Oral Delivery of Peptides
  • Table -3 : Potential Regulatory Pathways for Drug Products Under Development
  • Table -4 : Time and Cost Comparison-ANDA vs 505(b)(2)

Company Name

  • Glide Pharma
  • Caretek Medical Ltd .
  • Arecor Ltd
  • Critical Pharmaceuticals
  • IotaNano
  • MedPharm Ltd
  • Q Chip Ltd
  • XstalBio Ltd
  • Skye Pharma
  • Ethypharm
  • Flamel Technologies
  • InSiteVision
  • Durect
  • Depomed
  • Impax Laboratories
  • Banner Caps
  • Medincell .
  • Pacira Pharmaceuticals.
  • InnoCore Pharmaceuticals.
  • Chiasma Pharma.
  • D-Pharm
  • Emisphere Technologies .
  • ALZA Corporation
  • Antares Pharma
  • Camurus ...
  • Xspray Microparticles AB
  • Octoplus
  • Sigmoid Pharma Ltd
  • EmulTech
  • Corium International
  • Endo Pharmaceuticals
  • Zogenix
  • Star Pharma
  • QLT Inc
  • Bend Research
  • Bind Biosciences
  • Apricus Bio
  • Merrion Pharmaceuticals
  • Aptalis
  • Grunenthal GmbH
  • Alkermes
  • InnerCap Technologies Inc
  • Scolr Pharma
  • Catalent
  • SPI Pharma
  • CIMA Drug Delivery Technologies
  • Skinvisible pharmaceuticals
  • SEPS Pharma
  • Unigene Laboratories
  • Kurve Technology
  • Egalet Ltd
  • ThioMatrix
  • NAL Pharma
  • GL Pharmatech
  • Dexcel Pharma
  • Plx Pharma
  • Cosmo Pharmaceuticals
  • Cambrex Corporations
  • Supernus Pharmaceuticals
  • Tris Pharma
  • Orexo
  • Cipher Pharma
  • Aegis Therapeutics
  • Alpex Pharma
  • IntelGenx Corp
  • MonoSol Rx
  • Purdue Pharma
  • Patheon Inc
  • URL Pharma
  • Xenoport
  • Novartis
  • Pfizer
  • Echo Pharmaceuticals
  • Pozen Inc.
  • Osmotica Pharmaceuticals
  • KV Pharmaceuticals
  • Veloxis Pharma
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