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Exclusivity is exclusive marketing rights granted by the Health Authority upon approval of a novel drug molecules and can run concurrently with a patent or not. It prevents the submission or effective approval of generic applications and was designed to promote a balance between new drug innovation and generic drug competition.


Every region has two different types of exclusivities.

  1. Data Exclusivity
  2. Market Exclusivity

Data exclusivity is the exclusive rights to the results of preclinical tests and clinical trials on the medicine.

Market exclusivity is the time to market the novel drug and provided to the innovator during which other alternative drugs are not approved.


New Chemical Entity (NCE) Exclusivity:

  • FDA grants NCE status a drug that contains no active moiety that has been approved under section 505(b) 
  • Prevents FDA from accepting any ANDA or 505(b)(2) application for review that contains the same active moiety for: 

five years if an ANDA or 505(b)(2) does not contain a paragraph IV certification to a listed patent 

four years if an ANDA or 505(b)(2) is submitted containing a paragraph IV certification to a listed patent, which is referred as NCE-1 application.

Tenure: 5 years;

Orphan Drug Exclusivity (ODE)  

  • Granted to drugs designated and approved to treat diseases or conditions affecting fewer than 200,000 in the U.S. (or more than 200,000 and no hope of recovering costs) 
  • The exclusivity starts from time of approval of NDA or BLA 
  • Prevent FDA from approving any other application (ANDA, 505(b)(2) or “full” NDA or BLA) for the same drug for the same orphan disease or condition.

Tenure: 7 years;

Paediatric Exclusivity (PED)

  • FDA grants an additional 6-months of market protection at the end of listed patents and/or exclusivity for sponsor’s drug products containing the active moiety.
  • The sponsor has to conduct and submit paediatric studies on the active moiety in response to a Written Request from FDA. 
  • Paediatric exclusivity takes on characteristics of five-year, three year or orphan exclusivity when it attaches to those protections.

Tenure: 6 months;

New Clinical Study Exclusivity:

  • Innovators conduct multiple additional clinical studies that lead to new or changed formulations, dosing regimens or patient population. Based on the new clinical investigations that were essential for approval FDA provides a new clinical study exclusivity.
  • Granted to drug when application or supplement contains reports of new clinical investigations (not bio-availability studies) conducted or sponsored by applicant and essential for approval.
  • Prevent FDA from approving, for a three-year period, any ANDA or 505(b)(2) application that relies on the information supporting the approval of the drug or the change to the drug for which the information was submitted and the exclusivity granted
  • Also known as data exclusivity, which forbids the FDA from approving a generic application for the new dosage form or use for three years after the first NDA approval. (Section viii)

Tenure: 3 years;

Patent Term Restoration

The patent’s term can be extended by a maximum of five years or 14 years of effective patent life, whichever is less. Specifically, the patentee is entitled to a credit for the time the FDA was reviewing the first drug application. Only one extension can be granted in connection with a particular product.

Tenure: 5 or 14 years;


Biologics usually have a longer exclusivity period than any other drugs. Biologic exclusivity is 12-years of total market protection that includes 4 years before an application for a biosimilar and 8 additional years before an application may be approved.

The purpose of the extended exclusivity for biologics is to promote innovation and continued development of these novel therapies.

Tenure: 12 years;

Patent Challenge (PC)

The first-filer of an ANDA with a Paragraph IV certification rewarded with the 180-days of market exclusivity, during which the FDA will not approve any other ANDAs having a Paragraph IV certification for a generic version of the same RLD and may enter the market.

Tenure: 180 days or 6-months;

Delay by HA`S

If the patentee sues within the 45-day period, the FDA may not grant final approval of the generic application for 30 months from the NDA holder and patentee’s receipt of the Notice Letter (30-month stay). However, if the RLD has NCE exclusivity, the 30-month stay does not begin to run until the NCE exclusivity expiration.

Tenure: 30-months or 14 years;


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