Friday, August 27, 2010

Market exclusivities for pharmaceuticals in USA

Freinds this topic is specially for the students and who are new to the field of patent and related things. Here i have explaiend some exclusivities available to pharmaceutical products in USA.

1) New Chemical Entity (NCE) (5 years)
It applies to any new drug that does not contain active ingredient (active moiety) earlier approved in as NDA by FDA. The term is 5 years and no any generic player can market generic product before expiry of NCE. However generic player can file the ANDA after the expiry of 4 years of NCE if they submit the paragraph IV certification. NCE can be extended by 6 months if pediatric exclusivity is granted.

2) First ANDA patent challenger (180 days)
After NDA, the very first ANDA alongwith Para IV certificate will get this 180-day exclusivity against subsequent ANDA filers. FDA will not approve another ANDA during 180 days exclusivity of the first ANDA holder.

3) New Clinical Investigations (3 years)
It applies to the new indication of known compound. Sponsor must submit the clinical trial data for the new indication. Generic player will not get the approval till the expiry of the exclusivity. However generic player can carve out the new indication and can go ahead with the known previous indication.

4) Orphan Drug (7 years)
It applies to the first NDA or BLA approved for a “rare” disease or condition. The definition “rare” disease is defined by any disease that affects less than 200,000 people in US, or affects more than 200,000 people in US but there is no “reasonable” expectation that development costs for drug will be recovered from US sales. Till the expiry of this exclusivity no any generic player can get the approval form the FDA for the same disease or condition.

5) Pediatric Exclusivity(6 months)
It applies to all the patents listed in the orange book as well as all other regulatory exclusivities. For this exclusivity, sponsor must provide the data of the pediatric clinical trials as requested by the FDA. Two separate 6 months pediatric extension can be possible.

6) Animal product exclusivity (5 years)
Veterinary drugs can also receive market exclusivity under the Generic Animal Drug and Patent Term Restoration Act (“GADPTRA”). Exclusivity is for either 3 or 5 years, during which time no other generic copy may be approved (in the case of 3-year exclusivity) or no other generic application may be submitted (in the case of 5-year exclusivity).

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