Pipeline

Our pipeline is our engine for growth.

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\r\n\r\nWe believe that commitments by the FDA under the Generic Drug User Fee Act (GDUFA) will start to dramatically reshape the generic drug landscape. We count on our Product Development team, as well as external opportunities identified through our Business Development team, to strengthen our pipeline.\r\n\r\nWe have 33 topical Abbreviated New Drug Applications (ANDAs) on file at the FDA, representing a total addressable market of approximately $1.6 billion (IMS, May 2016).

GDUFA
Year
ANDA #
4
ANDA 44
ANDA 43
ANDA 42
ANDA 41
ANDA 40
ANDA 39
ANDA 38
ANDA 37
ANDA 36
ANDA 35
ANDA 34
ANDA 33
3
ANDA 32
ANDA 31
ANDA 30
ANDA 29
ANDA 28
ANDA 27
ANDA 26
ANDA 25
ANDA 23
ANDA 22
ANDA 21
ANDA 20
2
ANDA 19
ANDA 15
ANDA 14
ANDA 13
1
ANDA 12
ANDA 11
ANDA 10
ANDA 9
ANDA 8
Pre-GDUFA
ANDA 7
ANDA 6
ANDA 5
ANDA 4
ANDA 3
ANDA 2
ANDA 1
Pre-GDUFA GDUFA Year 1 GDUFA Year 2 GDUFA Year 3 GDUFA Year 4
3Q10 4Q10 1Q11 2Q11 3Q11 4Q11 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13 1Q14 2Q14 3Q14 4Q14 1Q15 2Q15 3Q15 4Q15 1Q16 2Q16 3Q16
Jun '16
May '16
Mar '16
Mar '16
Mar '16
Dec '15
Dec '15
Dec '15
Dec '15
Dec '15
Nov '15
Oct '15
Sep '15
Sep '15
Jul '15
Jun '15
Jun '15
May '15
Apr '15
Mar '15
Dec '14
Dec '14
Nov '14
Approved Feb '16
Nov '14
Jun '14
May '14
Feb '14
Oct '13
Sep '13
Jul '13
Mar '13
Feb '13
Approved Feb '16
Jan '13
APPROVED MAY '16
Jun '12
APPROVED JUL '16
Jun '12
APPROVED JUL '16
May '12
Approved Mar '14
Nov '11
Nov '11
Dec '10
Approved Jul '15
Aug '10
*GDUFA is the FDA's Generic Drug User Fee Act. Each GDUFA year begins on October 1. ANDAs 16,17,18 and 24 were withdrawn in Q3 '15. Planned resubmission in 2016.