Factors affecting potential launch of generic version of Alzheimer’s disease treatment Ebixa® (Memantine)

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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article on Ebixa® (Memantine) based on information from its flagship product Ark Patent Intelligence.

Also known as Namenda®, the article gives a brief outline of factors affecting the potential launch of generic versions of Memantine, Merz’s N-methyl-D-aspartate antagonist. Lundbeck reported Ebixa® sales of DKK 2.1 billion (USD 420 million) in 2013. In the US, Forest reported Namenda® sales of USD 1.5 billion during fiscal year 2014.

  •     Patent protection, for indicated use of Memantine in the treatment of Alzheimer’s disease, via patent families with priorities US33187289A (1989-03-31) and EP89106657A (1989-04-15), have expired in Australia, Canada and Europe.
  •     US member 5,061,703 (‘703) of the EP89106657A (1989-04-15) family remains in force until April 2015 due to the grant of a 5 year S156 patent term extension; and the expiry has been further extended 6 months until October 2015. The paediatric extension for studies into its use in the treatment of autism was granted in June 2014.
  •     In Europe, Supplementary Protection Certificates (SPCs) to the EP member 0,392,059 of the EP89106657A (1989-04-15) family were found to be invalid following nullification proceedings brought about by generic competitors for countries including Germany, Spain and the United Kingdom.
  •     Family with priority US54071304P (2004-01-29), which protects the Memantine extended release (XR) dosage forms is considered to constrain generic entry for this dosage form.
  •     Forest and Adamas filed patent infringement suits in the US District Court of Delaware on 31/01/2014 to the FDA Orange Book listed patents in families US54071304P (2004-01-29) and US5812420P (2004-06-17), within 45 days after Sun, Teva and Wockhardt submitted ANDAs with Paragraph IV certifications to all patents; thus, triggering a 30 month stay preventing FDA approval until June 2016 or until conclusion of patent litigation.
  •     Although NCE data exclusivity in Europe prevented the filing of generic application until May 2012, invalidation of SPCs has allowed the EU market to be subject to generic competition, where Lundbeck has seen revenues decrease by 70% in Q1 2014, as compared to Q1 2013.
  •     Fierce generic competition is anticipated in the US with tentative Abbreviated New Drug Applications being held by generic competitors.

GenericsWeb notes that: “patent protection in Australia, Canada and Europe has expired, opening the market to generic competition. The absence of a sustained-release formulation in the region has increased Lundbeck’s susceptibility to generic erosion. In the US, use patent protection via ‘703 is due to expire in April 2015, has been awarded 6 month paediatric extension, further extending exclusivity to October 2015. Late stage product lifecycle management undertaken by Forest, through switching to the XR formulation by discontinuing their manufacturing and marketing of the IR tablets and new fixed dose combination of Memantine and Donepezil; may see Forest hold some share of the US market beyond the expiry of the ‘703. Generic competitors have developed and patented their own technology for XR formulations of Memantine in an attempt to circumvent innovator patents. In addition, generic competitors have filed Paragraph IV certifications to OB listed patents in their ANDA applications for an equivalent XR Memantine formulation. However, they are unlikely to be given FDA approval until at least June 2016 or conclusion of patent infringement litigation.”
You can read the entire article here: http://learnabout.arkpatentintelligence.com/drug-in-focus-memantine

GenericsWeb is a global provider of data for the pharmaceutical sector and provides IP solutions to pharmaceutical firms in every continent. It currently supplies data to 8 of the top 10 generics firms in the world. GenericsWeb is also responsible for a series of SPC validity studies that have uncovered a string of critical SPC protection issues across Europe since 2011.

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