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High Barrier Generics > Tactics
TWi- insights into complex technologies and difficult-to-manufacture generics
TWi's focus is on the development of High Barrier Generics for the US market. TWi intends to develop Paragraph IV High Barrier Generics with first-to-file (FTF) status and 180-day exclusivity, first-to-market (FTM) High Barrier Generics, or generic drugs with high technical barrier and limited number of competitors.
TWi has already filed several abbreviated New Drug Applications (ANDAs) for its high barrier generic products with US FDA. In addition, TWi's R&D pipeline consists of 15~20 High Barrier Generics with high market value or technical barrier. Unlike the regular generic pharmaceutical products, there is only a handful of pharmaceutical companies worldwide focusing on High Barrier Generics, thus price discounts for High Barrier Generics will be much less than the regular generics. To excel in this market and to stay ahead of the competition, TWi's competitive advantage are as follow:
- Innovative Formulation Design and Development
Unlike the traditional generics pharmaceutical companies, TWi possesses the formulation and R&D capacity and know-how required to challenge the patents of branded drugs. In addition, TWi has the expertise in the development of analytical and validation methods.
- Patent Analysis and Legal Strategy
TWi is well experienced in fully analyzing the patent claims for each compound and in designing subsequent legal strategy to bypass or invalidate the brand manufacturers' patent claims.
- Design of Bioequivalent (BE) and Pharmacokinetic (PK) Clinical Studies
TWi is experienced in designing and executing cost-effective BE clinical studies under US FDA guidelines to demonstrate TWi's generic products are bioequivalent to branded products.
- State-of-the-Art and Approved Production Facility
TWi's Chungli plant has completed the audit by US FDA and TFDA, and, since 2009, TWi's Chungli plant has consistently supplied and exported good quality pharmaceutical products to US.
- Regulatory Affairs
Since TWi has filed several ANDAs to US FDA, TWi is well experienced in preparing and drafting ANDA application documents. Therefore, TWi is able to submit the most complete ANDA application package shortly after the completion of BE studies in order to ensure that US FDA will accept TWi's ANDA application in the shortest possible timeframe.