PharmPK Discussion - BE studies

• On 15 Mar 2007 at 00:43:36, nehmat atallah (nehmat2.aaa.yahoo.com) sent the message
  

  
  ear Sir,
  Concerning generic products, if we conduct bioequivalence study, do
  we  infringe the data protection of the originator product (if this
  data protection exist); please note that this BE will be used in the
  preparation of the registration file to be submitted when exclusivity
  period expire.
  Thank you for replying.
  best regards
  Neemat - Lebanon
  
  

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• On 18 Mar 2007 at 12:32:02, "Sumanta Goswami" (sumantag.aaa.gmail.com) sent the message
  

  
  Dear Nehmat,
  
  A generic drug has similar effects in terms of its rate and extent of
  absorption of an approved product, which has to be proved by the
  generic company. In other words the generic drug has similar effects
  incuring a disease as the approved product. The generic approval
  process is called Abbreviated New Drug  application (ANDA).
  While filing an ANDA, the generic company has to choose one of the
  following four options (referred to as paras).
  
  Para I - The drug has not been patented
  Para II- The patent for the drug has already expired
  Para III- The patent for the product exists but the generic company
  wants to enter
  the markets after the date of patent expiry passes.
  Para IV- Patent is not infringed upon or is invalid.
  
  In a Para III filing the company acknowledges the patent of the
  approved drug and intends to enter the market after the patent for
  the approved product expires. In Para IV filings the company claims
  that the generic product of the company does not infringe upon the
  existing patent or the patent of the branded product is invalid and
  the company strives to win an exclusivity of 180 days during which
  the margins for the product are very high.
  
  Generally Generic manufacturer go for para III filing. Before
  starting BE studies the company need to inform Regulatory bodies and
  has to purchase refrence product from Innovator.
  By these ways generic company does not infringe patent / data
  protection.
  Hope I answered your question properly.
  
  Regards,
  Sumanta.
  
  

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