Pediatric Exclusivity Statistics

as of October 31, 2015

Review DivisionProposed Pediatric Study Requests (PPSRs) ReceivedWritten Requests Issued *

DCRP (Division of Cardiovascular Renal Products)

   82  47

DNP (Division of Neurology Products)

   75  35

DPP (Division of Psychiatry Products)

   56  40

DOP1 (Division of Oncology Products 1)

   33  21

DOP2 (Division of Oncology Products 2)

   33  17

DHP (Division of Hematology Products)

   59  27

DHOTP (Division of Hematology Oncology Toxicology Products)

    0   0

DMIP (Division of Medical Imaging Products )

   15   7

DAAAP (Division of Analgesia, Anesthesia and Addiction Products)

   79  39

DGIEP (Division of Gastroentereology and Inborn Products)

   65Updated  27Updated

DMEP (Division of Metabolism and Endocrinology Products)

  119  44

DAIP (Division of Anti-Infective Products)

  22   6

DAVP (Division of Anti-Viral Products)

  58Updated  47

DDDP (Division of Dermatology and Dental Products)

  52  20

DNDP (Division of Nonprescription Drug Products)

  11   5

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  54Updated  27

DBRUP (Division of Bone, Reproductive and Urologic Products)

  34  13

DTOP (Division of Transplant and Ophthalmology Products)

  41  54
TOTAL888  476Updated

Numbers reflect the number of drugs (i.e., active moiety) per division.

Written Requests with PPSRs - 396Updated  
Written Requests without PPSRs - 80  
Incomplete Responses - 435 Updated 
PPSR Withdrawals - 31
Written Request Withdrawals - 9
Written Request Amendments - 563 Updated 
TOTAL ACTIONS = 1514Updated

*This column will never equal the number of proposals submitted, because a Written Request may be issued without a proposal, and a proposal may result in an action that is incomplete instead of a Written Request.

*New/Transfers/Miscodes- some PPSRs were transferred to other divisions or deleted due to miscodes.  The PPSRs are organized by therapeutic area within the Pediatric Exclusivity database.

Page Last Updated: 11/10/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.