How Long Will We Have to Wait for Generic Invega® Products (Paliperidone)?

Sydney, Australia (PRWEB) May 24, 2010 - GenericsWeb, the leader in pharmaceutical patent searching and analysis, recently published an article based on its proprietary patent intelligence for Janssen's Invega® (Paliperidone), revealing that data exclusivity and marketing exclusivity are likely to delay generic versions of Paliperidone well beyond the expiry of the molecule patent, but that patent protection of key processes and dosage forms may further delay entry in some countries.

Key findings of the article include:

* In most major markets, with the US as a notable exception, the data exclusivity expires well beyond the expiry of patents protecting the molecule per se, even with the patents having granted extensions of term. However, in the US a key non Orange Book-listed enantiomeric separation patent will create problems for generic API manufacturers until 2018.

* Formulation patents protecting the injectable product will cause generic companies to undertake some heavy R&D to produce non-infringing bioequivalent products in order to launch this dosage form upon expiry of relevant market exclusivity. However, patent protection has also been identified comprising two PCT applications with granted European patents and six corresponding US applications relating to the osmotic dosage forms used in the marketed Invega® oral formulation. In particular, patent application US2009202631 (and a pending Australian equivalent) seeks to protect a simple extended release dosing range which, if granted, will prevent any sustained release oral dosage forms of Paliperidone from entering the market until 2023.

* Patenting activity relating to Paliperidone by generics companies is relatively high at this early stage in the brand product's lifecycle. Patent analysis shows Teva, the world's largest generics company, as having the greatest number of patent families relating to Paliperidone. The innovator, Janssen, is second on the list with 8%, but with 62% of all Paliperidone-related patents filed spread across companies that all have less than 5% of the total filings, it seems, according to GenericsWeb patent analyst Stuart Robinson, that "...plenty of others are keen to protect their interests in this molecule resulting from extensive R&D effort."

* The types of patent protection being sought is evenly spread across processes, formulation and use. For example, the large number of process based patents is due to Paliperidone existing as a racemic mixture and patenting activity reflects the efforts to purify the enantiomeric Paliperidone mixture or an intermediate prior to a final synthetic step. There is also a high proportion of molecule form patenting. This may indicate early interest by generics companies investigating salts and polymorphic forms, possibly using experience gained from developing Risperidone.

* Invega® (Paliperidone) and Invega Sustenna® (Paliperidone palmitate) are marketed by Janssen and Johnson & Johnson respectively. Paliperidone, the active metabolite of Risperidone, is indicated for the treatment of schizophrenia and schizoaffective disorder, the latter indication optionally in combination with antidepressants and/or mood stabilisers.

You can read the entire article here: http://www.genericsweb.com/druginfocus/Paliperidone/

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