· Abacavir was developed and marketed by GlaxoSmithKline and is prescribed as either an oral tablet or as an oral solution, for use in combination with other antiretrovirals, both of which were given market approval for the US in 1998.
· Patents which protect the Abacavir molecule per se have expired in the US, but equivalent patents are still valid in the majority of European markets and Australia until June 2014 due to granted supplementary protection certificates;
· NCE data exclusivity periods have expired in all the major territories.
· Patent family with priority number GB8815265A (1995-03-30)
· The patent families with priority numbers GB9506489A (1997-05-17)
· In the US, Mylan was granted 180-day market exclusivity for Abacavir tablets preventing other generic competitors from entering the market.
· Teva has secured market authorisation in the EU for the Abacavir/Lamivudine/
· Although a six month paediatric extension has been granted for US 6,417,191 (‘191) that expires in September 2016, the USFDA awarded Lupin an ANDA for the Abacavir/Lamivudine/
· ViiV filed a suit against Teva in the US District Court of Delaware on 5th August 2011 in relation to their ANDA for the Abacavir/Lamivudine combination (11-cv-00688 consolidated with 11-cv-00576)
· In Canada, ViiV and GlaxoSmithKline have filed suits against both Teva (T-1517-13) and Apotex (T-336-14,T-
GeneicsWeb notes that: “patent and SPC protection for the molecule, its oral tablet and solution is due to expire in most jurisdictions with the US already having a market open to generic competition. The ability to launch a two or three drug co-formulation has been tested in the US; however the wisdom of launching before any final Court decision remains to be seen. Successful launch of Abacavir generics has been possible due to the lack of litigation over the patent protecting the Abacavir hemisulphate salt. The market for HIV treatments is a multi-billion dollar industry which may prove financially viable for generic Abacavir competitors given that the three drug combo represents some of the first anti-HIV drugs to be open to generic competition.”
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