There is on-going development of generic EU CTD Dossier of Ropinirole HCl, filmcoated tablets, 0.25/0.5/1/2 mg.
Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.
Ropinirole (Requip, Ropark, Adartrel) is a non-ergoline dopamine agonist. It is manufactured by GlaxoSmithKline (GSK) and Sun Pharmaceutical. It is used in the treatment of Parkinson's disease. Ropinirole is also one of two medications in the United States (U.S.) with an Food and Drug Administration (FDA) approved indication for the treatment of restless legs syndrome (RLS), the other being pramipexole (Mirapex). The discovery of the drug's utility in RLS has been used as a successful example of drug repurposing.
Ropinirole's patent expired in May 2008, and the drug is now available in generic form.
More details at: http://www.rxlist.com/requip-drug.htm.
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Pharma licensing | Out-licensing (offer) |