Factors Affecting Potential Launch of Generic Version of HIV Treatment Ziagen (Abacavir)

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GenericsWeb

May 13, 2014, 04:00 ET

Sydney, Australia (PRWEB) May 13, 2014 -- GlaxoSmithKline, a major shareholder in ViiV Healthcare, reported revenue of USD1.35 billion for the combination products of Epzicom® and Trizivir® during the 2013 financial year, a 10% increase over the 2012 financial year.

  • 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; and in Canada until June 2016.
  • NCE data exclusivity periods have expired in all the major territories.
  • Patent family with priority number GB8815265A (1995-03-30) is considered to be a constraint to generic competition for the co-formulated dosage forms of Abacavir/Lamivudine and Abacavir/Lamivudine/Zidovudine until at least March 2016.
  • The patent families with priority numbers GB9506489A (1997-05-17) and GB9802472A (1998-02-06), protecting different salts of Abacavir, including the hemisulphate salt, and the oral solution comprising Abacavir respectively; are not considered to be a constraint to generic competition.
  • 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/Zidovudine combination, using the free base form instead of hemisulphate salt. However, no market authorisations for the single dosage form have been awarded to generic competitors in the EU.
  • 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/Zidovudine tablet allowing them to launch at risk pending resolution of the litigation against them by ViiV, filed in June 2011 in the US District Court of Delaware (11-cv-00576).
  • 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) where Teva agreed that they infringed certain claims of US ‘191.
  • In Canada, ViiV and GlaxoSmithKline have filed suits against both Teva (T-1517-13) and Apotex (T-336-14, T-333-14, T-335-14) in the Canadian Federal Court on 31th January 2014 and 12th September 2013 respectively, after these companies filed Abbreviated New Drug Submissions for generic Abacavir.

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.”

You can read the entire article here: http://learnabout.arkpatentintelligence.com/drug-in-focus-abacavir

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Yoann Bretonnet, GenericsWeb, +61 292627696, [email protected]