Patent Expiry Database

Patents usually expire after 20 years from the date of filing. When the patent expires, other manufacturers can apply for the abbreviated new drug application (ANDA) to the FDA for approval to market the generic version.

Supplementary Protection Certificate (SPC): A supplementary protection certificate (SPC) comes into existence only after the patent expiration of the innovative drug. It usually remains in force for a period of maximum five years.

Para IV: Para IV approve the exclusivity for 180 days to the first company which submits a completed ANDA (Abbreviated New Drug Application)

Market Exclusivity: Patent term extension is provided in the form of market exclusivity to compensate the application holder for the time lost and the heavy expenses incurred for the research & development of the drug.

Patent Expiry database of Chemxpert provides following information:

  • Patent Expiry:
    • Active ingredients: Active ingredient of the drug
    • Application Type: NDA & ANDA
    • Application No: Application no. for the approved drug
    • Trade name: Proprietary name or the brand name of the product
    • Patent No: It gives the patent protection no. of the product.
    • Patent Expiry Date: It gives the date on which patent is going to be expired.
  • Exclusivity: In addition to the above information exclusivity tab provides the information regarding the type of exclusivity i.e. Paediatric Exclusivity (PED), Orphan Drug Exclusivity (ODE), New Chemical Entity Exclusivity (NCE), Generating Antibiotic Incentives Now (GAIN) etc.
  • Supplementary Protection Certificate (SPC): Apart from the other information, it gives information regarding the granted period of extension.
  • Para IV: The tab of Para IV present the information regarding the Active ingredient of the drug, trade name, dosage form, dosage strength, NDA no. & date of para IV submission

Patent related information for Paracetamol in Patent Expiry Database

  • Patent Expiry: 31 products are available for patent expiry details.
  • Exclusivity: 3 products are available for exclusivity details.
  • SPC: 29 products are available for SPC details.
  • Para IV: 5 products are available for Para IV details.