Patents and Exclusivities | Differences and Importance


Property right issued by USPTO to an inventor “to exclude others from making, using, sale, import the invention into the US for a period of 20 years from the date of filing”. Patents can be issued or expire at any time regardless of the drug’s approval status

Patent information is required to be submitted with original NDAs and supplements on FDA Form 3542a – prior to approval and FDA Form 3542 -within 30 days after the approval. This information in Form 3542 is published in the Orange Book patent information and ANDA holders are required to make a certification for these timely listed orange book patents.

FDA only considers:
1) Patents that claim the active ingredient(s)
2) Drug product patents which include formulation/ composition patents
3) Use patents for a particular approved indication or method of using the product
4) Certain other patents as detailed on FDA Form 3542.


Exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. It prevents the submission or effective approval of ANDAs, or applications described in Section 505(b)(2) of the Act, and was designed to promote a balance between new drug innovation and generic drug competition. Exclusivity attaches upon approval of a drug product if the statutory requirements meet.


  1. Orphan Drug Exclusivity (ODE) – Granted to drugs designated and approved to treat diseases or conditions affecting fewer than 200,000 in the U.S.), 7 years
  2. New Chemical Entity Exclusivity (NCE) – Granted to a drug that contains no active moiety that has been approved by FDA under section 505(b), 5 years
  3. New Clinical Investigation Exclusivity – Granted to drug when application or supplement contains reports of new clinical investigations (not bioavailability studies) conducted or sponsored by applicant and essential for approval, 3 years
  4. Pediatric Exclusivity (PED) – 6 months added to existing patents/exclusivity for sponsor’s drug products containing the active moiety, when the sponsor has conducted and submitted pediatric studies on the active moiety in response to a Written Request from FDA.
  5. Patent Challenge (PC) – Provides an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and running the risk of having to defend a patent infringement suit.
  6. Competitive Generic Therapy (CGT) – 180 days (this exclusivity is for ANDAs only)

FDA does not send letters to the sponsor indicating the grant of exclusivity and Orange Book is the official vehicle for dissemination of this information.

In conclusion, patents and exclusivities may or may not run concurrently and cover the same aspects of the drug product. Both of them are crucial in protecting intellectual property and incentivizing innovation in the USA.

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Resource Person: Bharathi Kodali

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