Innovative Drug Delivery Systems: Novel Product and Formulation Technology Licensing Opportunities for Generic Pharmaceutical Companies

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Date: 15-Jun-2013
No. of pages: 123
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There are more than 1400 sustained or controlled release drugs approved all over the world. Revenues within the global generics market reached an estimated value of $265 b in 2012, showing a growth of 9.3% throughout the year. The contribution of generics is approximately 20% of the overall international pharmaceutical market. Utilization of generic in terms of volume is higher in the US and lower in Japan, 89% and 24% respectively.

The oral drug delivery market remains the largest slice of the overall drug delivery market, with more than 52% of 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) offer 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 current benefits enjoyed by the patients.

The generic market with reference to innovative molecule (NCE) has become very competitive as several companies have already filed ANDA's for potential generic drugs in the near term. The study of the 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 an enhanced life cycle for drugs under patent coverage (life cycle extension).

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

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

Innovative Drug Delivery Systems: Novel Product and Formulation Technology Licensing Opportunities for Generic Pharmaceutical Companies

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 and major Pharma companies
11. The discussed formulations proprietary technologies includes Colal, Glide SDI, Arestat, GeoClock, GeoMatrix, FlashTab, Lock Tab, Medusa, Eligen, Oradur, EnteriCare and Saber.

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