-
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Patent and Exclusivity Search Results
from query on Appl No 021588 Product 002 in the OB_Rx list.
Appl
No
Prod
No
Patent
No
Patent
Expiration
Drug Substance
Claim
Drug Product
Claim
Patent Use
Code
Delist
Requested
N021588
002
5521184
Jan 4, 2015
N021588
002
5521184*PED
Jul 4, 2015
N021588
002
6894051
May 23, 2019
Y
Y
U
-
649
N021588
002
6894051*PED
Nov 23, 2019
N021588
002
6958335
Dec 19, 2021
U
-
791
N021588
002
6958335*PED
Jun 19, 2022
N021588
002
7544799
Jan 16, 2019
Y
Y
N021588
002
7544799*PED
Jul 16, 2019
Appl No
Prod No
Exclusivity Code
Exclusivity Expiration
N021588
002
ODE
Feb 1, 2009
N021588
002
PED
Nov 10, 2008
N021588
002
PED
Aug 1, 2009
N021588
002
I
-
583
Dec 19, 2011
N021588
002
I
-
512
Oct 19, 2009
N021588
002
ODE
Oct 19, 2013
N021588
002
I
-
511
Oct 19, 2009
N021588
002
ODE
Oct 19, 2013
N021588
002
ODE
Oct 19, 2013
N021588
002
ODE
Oct 19, 2013
N021588
002
ODE
Oct 19, 2013
N021588
002
I
-
513
Oct 19, 2009
N021588
002
I
-
510
Oct 19, 2009
N021588
002
I
-
514
Oct 19, 2009
Additional information:
- Patents are published upon receipt by the Orange Book Staff and may not reflect the official
receipt date as described in 21 CFR 314.53(d)(5).
- Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and
submitted by the sponsor. These patents may not be flagged with respect to other claims which may apply.
View a list of all patent use codes
View a list of all exclusivity codes
Return to Electronic Orange Book Home Page
FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:
Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through December, 2009
Patent and Generic Drug Product Data Last Updated: February 04, 2010
|
Appl No |
Prod No |
Patent No |
Patent Expiration |
Drug Substance Claim |
Drug Product Claim |
Patent Use Code |
Delist Requested |
|---|---|---|---|---|---|---|---|
| N021588 | 002 | 5521184 | Jan 4, 2015 | ||||
| N021588 | 002 | 5521184*PED | Jul 4, 2015 | ||||
| N021588 | 002 | 6894051 | May 23, 2019 | Y | Y | U - 649 | |
| N021588 | 002 | 6894051*PED | Nov 23, 2019 | ||||
| N021588 | 002 | 6958335 | Dec 19, 2021 | U - 791 | |||
| N021588 | 002 | 6958335*PED | Jun 19, 2022 | ||||
| N021588 | 002 | 7544799 | Jan 16, 2019 | Y | Y | ||
| N021588 | 002 | 7544799*PED | Jul 16, 2019 |
Appl No
Prod No
Exclusivity Code
Exclusivity Expiration
N021588
002
ODE
Feb 1, 2009
N021588
002
PED
Nov 10, 2008
N021588
002
PED
Aug 1, 2009
N021588
002
I
-
583
Dec 19, 2011
N021588
002
I
-
512
Oct 19, 2009
N021588
002
ODE
Oct 19, 2013
N021588
002
I
-
511
Oct 19, 2009
N021588
002
ODE
Oct 19, 2013
N021588
002
ODE
Oct 19, 2013
N021588
002
ODE
Oct 19, 2013
N021588
002
ODE
Oct 19, 2013
N021588
002
I
-
513
Oct 19, 2009
N021588
002
I
-
510
Oct 19, 2009
N021588
002
I
-
514
Oct 19, 2009
Additional information:
- Patents are published upon receipt by the Orange Book Staff and may not reflect the official
receipt date as described in 21 CFR 314.53(d)(5).
- Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and
submitted by the sponsor. These patents may not be flagged with respect to other claims which may apply.
View a list of all patent use codes
View a list of all exclusivity codes
Return to Electronic Orange Book Home Page
FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:
Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through December, 2009
Patent and Generic Drug Product Data Last Updated: February 04, 2010
| Appl No | Prod No | Exclusivity Code | Exclusivity Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| N021588 | 002 | ODE | Feb 1, 2009 | ||||||||
|
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| N021588 | 002 | PED | Nov 10, 2008 | ||||||||
|
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| N021588 | 002 | PED | Aug 1, 2009 | ||||||||
|
|
|||||||||||
| N021588 | 002 | I - 583 | Dec 19, 2011 | ||||||||
|
|
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| N021588 | 002 | I - 512 | Oct 19, 2009 | ||||||||
|
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| N021588 | 002 | ODE | Oct 19, 2013 | ||||||||
|
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| N021588 | 002 | I - 511 | Oct 19, 2009 | ||||||||
|
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| N021588 | 002 | ODE | Oct 19, 2013 | ||||||||
|
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| N021588 | 002 | ODE | Oct 19, 2013 | ||||||||
|
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| N021588 | 002 | ODE | Oct 19, 2013 | ||||||||
|
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|||||||||||
| N021588 | 002 | ODE | Oct 19, 2013 | ||||||||
|
|
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| N021588 | 002 | I - 513 | Oct 19, 2009 | ||||||||
|
|
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| N021588 | 002 | I - 510 | Oct 19, 2009 | ||||||||
|
|
|||||||||||
| N021588 | 002 | I - 514 | Oct 19, 2009 | ||||||||
|
|
|||||||||||
Additional information:
- Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5).
- Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. These patents may not be flagged with respect to other claims which may apply.
View a list of all patent use codes
View a list of all exclusivity codes
Return to Electronic Orange Book Home Page
| FDA/Center for Drug Evaluation and Research |
| Office of Generic Drugs |
| Division of Labeling and Program Support |
| Update Frequency: |
| Orange Book Data - Monthly |
| Generic Drug Product Information & Patent Information - Daily |
| Orange Book Data Updated Through December, 2009 |
| Patent and Generic Drug Product Data Last Updated: February 04, 2010 |
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