Teva Pharmaceutical’s research pipeline
The combined Teva Pharmaceutical–Allergan Generics company filed 65 ANDAs (Abbreviated New Drug Applications) in 2015. The company also filed 65 dossiers in Europe. If they’re approved by the European Patent Office, they could be used to expand into multiple countries in the European Union. These 65 dossiers have resulted in around 1,600 regulatory filings. They include countries in the European Union as well as other countries that permit the use of these dossiers. The company also filed 22 dossiers in Canada, 17 in Japan, and 14 in Russia in 2015.
With various regulatory authorities around the world approving these applications, Teva Pharmaceutical (TEVA) may witness a rise in profit margins as well as share prices. This may also have a positive impact on the share prices of the Vanguard FTSE All-World ex-US ETF (VEU). Teva Pharmaceutical makes up about 0.50% of VEU’s total portfolio holdings.
The above graph shows that Teva Pharmaceutical submitted 25 first-to-file (or FTF) applications in 2015. Twenty of them belonged exclusively to the company. These numbers are significantly higher than the FTF applications submitted by other generic players such as Mylan (MYL), Endo International (ENDP), and Akorn (AKRX).
This trend continued in 2016. Of the 27 FTF applications listed on the FDA’s (U.S. Food and Drug Administration) website, 13 have been submitted by Teva Pharmaceutical. Teva has also exclusively submitted 12 of the 13 FTF applications in 2016. To know how FTF applications drive growth for a generic pharmaceutical company, please refer to Is a Para IV Filing Rewarding for a Generic Company?