Orange Book product · Brand (NDA)
OTIPRIO
CIPROFLOXACIN
At a glance
Dec 10, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 10, 2015
10 yr 8 mo ago
Today
Patent 11369566 expires
Listed drug product patent expiration.
Apr 21, 2029
in 2 yr 11 mo
Patent 9205048 expires
Listed method-of-use patent (U-1793) expiration.
Apr 21, 2029
in 2 yr 11 mo
Patent 9603796 expires
Listed drug substance patent expiration.
Apr 21, 2029
in 2 yr 11 mo
Patent 9233068 expires
Listed drug product patent expiration.
Dec 11, 2029
in 3 yr 6 mo
Patent 8318817 expires
Listed method-of-use patent (U-1792) expiration.
Apr 27, 2030
in 3 yr 11 mo
Patent 9220796 expires
Listed drug product patent expiration.
Jul 01, 2035
in 9 yr 2 mo
Patent 11040004 expires
Listed method-of-use patent (U-2252) expiration.
Nov 12, 2037
in 11 yr 7 mo
Patent 11246863 expires
Listed drug product patent expiration.
Nov 27, 2038
in 12 yr 7 mo
Pharmaceutical detail
Active ingredient
CIPROFLOXACIN
Strength
6% (60MG/ML)
Dosage form
INJECTABLE, SUSPENSION
Route
OTIC
TE code
Not listed
Application
NDA 207986
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.
- 1997CIPROBrand (NDA)
NDA 020780 · BAYER HLTHCARE
- 1990CIPROBrand (NDA)
NDA 019847 · BAYER HLTHCARE
- 1990CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019857 · BAYER HLTHCARE
- 1990CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019858 · BAYER PHARMS
- 2014CIPROFLOXACINGeneric (ANDA)
ANDA 200563 · CHARTWELL
- 2009CIPROFLOXACINGeneric (ANDA)
ANDA 076717 · HIKMA FARMACEUTICA
- 2009CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078431 · HIKMA FARMACEUTICA
- 2008CIPROFLOXACINGeneric (ANDA)
ANDA 078062 · BAXTER HLTHCARE CORP
- 2008CIPROFLOXACIN IN DEXTROSE 5%Generic (ANDA)
ANDA 076757 · HIKMA FARMACEUTICA
- 2008CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 077888 · BAXTER HLTHCARE
- 2008CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078024 · BAXTER HLTHCARE CORP
- 2008CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078114 · BEDFORD
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11369566 | Apr 21, 2029 | in 2 yr 11 mo | Product |
| 9205048 | Apr 21, 2029 | in 2 yr 11 mo | U-1793 |
| 9603796 | Apr 21, 2029 | in 2 yr 11 mo | SubstanceProductU-2252 |
| 9233068 | Dec 11, 2029 | in 3 yr 6 mo | Product |
| 8318817 | Apr 27, 2030 | in 3 yr 11 mo | U-1792 |
| 9220796 | Jul 01, 2035 | in 9 yr 2 mo | Product |
| 11040004 | Nov 12, 2037 | in 11 yr 7 mo | U-2252 |
| 11246863 | Nov 27, 2038 | in 12 yr 7 mo | Product |
