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patent certification on 505(b)(2)& ANDA

  1. PRESENTED BY : AMOL P.SATPUTE ROLL NO.22162007 M.PHARM 1st YEAR (2nd sem) GUIDED BY: DR.M.S. MUTHU SIR ASSOCIATE PROFESSOR DEPARTMENT OF PHARMACEUTICAL ENG.& TECHNOLOGY
  2. WHAT IS 505(b)(2) The 505(b)(2) is the new drug application (NDA) to food and drug administration (FDA) for drug approval . This type of application contain same active ingredient as previously approved drug . The pathway was created by the Hatch-Waxman amendment of 1984 it help to prevent the duplication of studies already performed on previously approved drug . 505(b)(2) contains full safety and effectiveness reports required for NDA approval but such studies not conducted by applicant . Hence the 505(b)(2) application is much less expensive & much faster rout to approval compared with 505(b)(1). 1
  3. EXAMPLES OF 505(b)(2) NDA New chemical entity Changes compared to previously approved drugs Indication Active ingredient Fixed combination Dosage form Route of administration Dosing regimen Strength Formulation ( not approvable under section 505(j)) 2
  4. NAVIGATING THE 505(B)(2) APPROVAL PATHWAY 3
  5. 505(J) ANDA APPLICATION Abbreviated new drug application (ANDA) contain data which submitted to FDA for approval of generic drug product. The Hatch – Waxman act 1984 related to approval of generic drug manufacturing from FDA . Generic drug product are compare to brand/ RLD product in dosage form , strength , ROA , quality , and intended use . 4
  6. ANDA CERTIFICATE CLAUSE PARAGRAPH I PARAGRAPH II PARAGRAPH III PARAGRAPH IV 5
  7. PARA IV CERTIFICATION After 45 days patent holder doesn’t sue applicant FDA may approve ANDA ANDA applicant granted approval After 45 days patent holder sues the applicant 30 months stay granted to patent holder 30 month stay expires For the first applicant the EMR of 180 days start with courts decision Subsequent approval for EMR are granted after expiry of first applicant 180 days 30 months stay not expired If judgement in favour of patent holder FDA can not approve ANDA until patent expiry. No entry occurs until patent expiry. Judgement favouring ANDA EMR of 180 days beings for first applicant. First applicant enters , subsequent applicant enter only after expiry of EMR for the first applicant. 6
  8. 7 ANDA REVIEW PROCESS
  9. NON PATENT EXCLUSIVITY IN THE USA 1. Orphan drug entity 7 year 2. New chemical entity 5 year 3. New clinical study exclusivity 3 year 4. Pediatric drug exclusivity 6 month 5. Patent challenges (ANDA only) 180 days 8
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