Orange Book product · Brand (NDA)
PENNSAID
DICLOFENAC SODIUM
At a glance
Jan 16, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 16, 2014
12 yr 7 mo ago
Today
Patent 8563613 expires
Listed drug product patent expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 8871809 expires
Listed method-of-use patent (U-1614) expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 9066913 expires
Listed drug product patent expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 9101591 expires
Listed drug product patent expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 9132110 expires
Listed method-of-use patent (U-1488) expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 9168304 expires
Listed drug product patent expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 9168305 expires
Listed method-of-use patent (U-1488) expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 9220784 expires
Listed method-of-use patent (U-1488) expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 9339551 expires
Listed method-of-use patent (U-1488) expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 9339552 expires
Listed drug product patent expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 9539335 expires
Listed method-of-use patent (U-1614) expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 8252838 expires
Listed drug product patent expiration.
Apr 21, 2028
in 1 yr 10 mo
Patent 8217078 expires
Listed method-of-use patent (U-1477) expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 8618164 expires
Listed method-of-use patent (U-1477) expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 8741956 expires
Listed method-of-use patent (U-1435) expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 9370501 expires
Listed method-of-use patent (U-1614) expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 9375412 expires
Listed method-of-use patent (U-1614) expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 9415029 expires
Listed method-of-use patent (U-1614) expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 8546450 expires
Listed method-of-use patent (U-1435) expiration.
Aug 09, 2030
in 4 yr 2 mo
Patent 8546450 expires
Listed method-of-use patent (U-1436) expiration.
Aug 09, 2030
in 4 yr 2 mo
Pharmaceutical detail
Active ingredient
DICLOFENAC SODIUM
Strength
2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 204623
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2014DYLOJECTBrand (NDA)
NDA 022396 · JAVELIN PHARMS INC
- 2009PENNSAIDBrand (NDA)
NDA 020947 · NUVO PHARMS INC
- 2007VOLTAREN ARTHRITIS PAINBrand (NDA)
NDA 022122 · HALEON US HOLDINGS
- 2000SOLARAZEBrand (NDA)
NDA 021005 · FOUGERA PHARMS
- 1998DICLOFENAC SODIUMBrand (NDA)
NDA 020809 · FALCON PHARMS
- 1991VOLTARENBrand (NDA)
NDA 020037 · NOVARTIS
- 2025DICLOFENAC SODIUMGeneric (ANDA)
ANDA 217646 · ENCUBE
- 2023DICLOFENAC SODIUMGeneric (ANDA)
ANDA 213040 · AUROLIFE PHARMA LLC
- 2022DICLOFENAC SODIUMGeneric (ANDA)
ANDA 212506 · ALEMBIC
- 2022DICLOFENAC SODIUMGeneric (ANDA)
ANDA 208098 · SUN PHARMA CANADA
- 2022DICLOFENAC SODIUMGeneric (ANDA)
ANDA 208021 · LUPIN PHARMS
- 2022DICLOFENAC SODIUMGeneric (ANDA)
ANDA 208198 · AMNEAL
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8563613 | Oct 17, 2027 | in 1 yr 4 mo | ProductU-1488 |
| 8871809 | Oct 17, 2027 | in 1 yr 4 mo | U-1614 |
| 9066913 | Oct 17, 2027 | in 1 yr 4 mo | ProductU-1488 |
| 9101591 | Oct 17, 2027 | in 1 yr 4 mo | ProductU-1488 |
| 9132110 | Oct 17, 2027 | in 1 yr 4 mo | U-1488 |
| 9168304 | Oct 17, 2027 | in 1 yr 4 mo | Product |
| 9168305 | Oct 17, 2027 | in 1 yr 4 mo | U-1488 |
| 9220784 | Oct 17, 2027 | in 1 yr 4 mo | U-1488 |
| 9339551 | Oct 17, 2027 | in 1 yr 4 mo | U-1488 |
| 9339552 | Oct 17, 2027 | in 1 yr 4 mo | ProductU-1488 |
| 9539335 | Oct 17, 2027 | in 1 yr 4 mo | U-1614 |
| 8252838 | Apr 21, 2028 | in 1 yr 10 mo | ProductU-1489 |
| 8217078 | Jul 10, 2029 | in 3 yr 1 mo | U-1477 |
| 8618164 | Jul 10, 2029 | in 3 yr 1 mo | U-1477 |
| 8741956 | Jul 10, 2029 | in 3 yr 1 mo | U-1435 |
| 9370501 | Jul 10, 2029 | in 3 yr 1 mo | U-1614 |
| 9375412 | Jul 10, 2029 | in 3 yr 1 mo | U-1614 |
| 9415029 | Jul 10, 2029 | in 3 yr 1 mo | U-1614 |
| 8546450 | Aug 09, 2030 | in 4 yr 2 mo | U-1435 |
| 8546450 | Aug 09, 2030 | in 4 yr 2 mo | U-1436 |
