Page 9 - Orange Book Cumulative Supplement 10 October 2012

1.6 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST

DESCRIPTION OF REPORT

This report provides summary counts derived from the product information
in the Prescription Drug Product List and the current Cumulative
Supplement. Products included in the counts are domestically marketed
drug products approved for both safety and effectiveness under section
505 of the Federal Food, Drug, and Cosmetic Act. Excluded are approved
drug products marketed by distributors; those marketed solely abroad; and
those now regarded as medical devices, biologics or foods.

The baseline column (Dec 2011) refers to the products in the Prescription
Drug Product List. For each three-month period, a column of quarterly
data is added which incorporates counts of product activity from the
previous quarter(s) with those in the baseline count.

DEFINITIONS

Drug Product

For this report, a drug product is the representation in the Prescription
Drug Product List of an active moiety (molecular entity and its salts,
esters and derivatives) either as a single ingredient or as a combination
product provided in a specific dosage form and strength for a given route
of administration with approval for marketing by a firm under a
particular generic or trade name.

New Molecular Entity

A new molecular entity is considered an active moiety that has not
previously been approved (either as the parent compound or as a salt,
ester or derivative of the parent compound) in the United States for use
in a drug product either as a single ingredient or as part of a
combination.

REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST

COUNTS CUMULATIVE BY QUARTER

CATEGORIES COUNTED DEC 2011 MAR 2012 JUN 2012 SEPT 2012 DEC 2012
DRUG PRODUCTS LISTED 14480 14711 14834 15160
SINGLE SOURCE 2451 2446 2428 2429
(16.9%) (16.6%) (16.4%) (16.0%)
MULTISOURCE 11953 12187 12328 12653
(82.5%) (82.8%) (83.1%) (83.5%)
THERAPEUTICALLY 11792 12037 12187 12509
EQUIVALENT (81.4%) (81.8%) (82.2%) (82.5%)
NOT THERAPEUTICALLY 161 150 141 144
EQUIVALENT (1.1%) (1.0%) (1.0%) (0.9%)

EXCEPTIONS 1 76 78 78 78
(0.5%) (0.5%) (0.5%) (0.5%)

NEW MOLECULAR ENTITIES
APPROVED 6 8 7 9
NUMBER OF APPLICANTS 810 826 826 836

1 Amino acid-containing products of varying composition (see Introduction, page xx of the
List).

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