Orange Book product · Brand (NDA)
LODOCO
COLCHICINE
At a glance
Jun 16, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 16, 2023
3 yr 1 mo ago
Today
Patent 10206891 expires
Listed method-of-use patent (U-3641) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 10265281 expires
Listed method-of-use patent (U-3639) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 10842762 expires
Listed method-of-use patent (U-3640) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 11026899 expires
Listed method-of-use patent (U-3639) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 11026900 expires
Listed method-of-use patent (U-3639) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 11026901 expires
Listed method-of-use patent (U-3638) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 11944594 expires
Listed method-of-use patent (U-3864) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 11944595 expires
Listed method-of-use patent (U-3867) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 11944595 expires
Listed method-of-use patent (U-3868) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 12233035 expires
Listed method-of-use patent (U-4132) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 12280025 expires
Listed method-of-use patent (U-4168) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 12364675 expires
Listed method-of-use patent (U-3639) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 9744144 expires
Listed method-of-use patent (U-3643) expiration.
Nov 01, 2033
in 7 yr 6 mo
Patent 10130585 expires
Listed method-of-use patent (U-3642) expiration.
May 09, 2034
in 8 yr
Pharmaceutical detail
Active ingredient
COLCHICINE
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215727
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2019GLOPERBABrand (NDA)
NDA 210942 · SCILEX PHARMS
- 2014MITIGAREBrand (NDA)
NDA 204820 · HIKMA INTL PHARMS
- 2009COLCRYSBrand (NDA)
NDA 022352 · TAKEDA PHARMS USA
- 2026COLCHICINEGeneric (ANDA)
ANDA 212880 · MICRO LABS
- 2026COLCHICINEGeneric (ANDA)
ANDA 210633 · MACLEODS PHARMS LTD
- 2024COLCHICINEGeneric (ANDA)
ANDA 217620 · ANNORA PHARMA
- 2024COLCHICINEGeneric (ANDA)
ANDA 215463 · AUROBINDO PHARMA LTD
- 2024COLCHICINEGeneric (ANDA)
ANDA 210757 · GRANULES
- 2022COLCHICINEGeneric (ANDA)
ANDA 209173 · STRIDES PHARMA
- 2022COLCHICINEGeneric (ANDA)
ANDA 215444 · AUROBINDO PHARMA LTD
- 2021COLCHICINEGeneric (ANDA)
ANDA 208993 · HETERO LABS LTD V
- 2021COLCHICINEGeneric (ANDA)
ANDA 203976 · PH HEALTH
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10206891 | Nov 01, 2033 | in 7 yr 6 mo | U-3641 |
| 10265281 | Nov 01, 2033 | in 7 yr 6 mo | U-3639 |
| 10842762 | Nov 01, 2033 | in 7 yr 6 mo | U-3640 |
| 11026899 | Nov 01, 2033 | in 7 yr 6 mo | U-3639 |
| 11026900 | Nov 01, 2033 | in 7 yr 6 mo | U-3639 |
| 11026901 | Nov 01, 2033 | in 7 yr 6 mo | U-3638 |
| 11944594 | Nov 01, 2033 | in 7 yr 6 mo | U-3864 |
| 11944595 | Nov 01, 2033 | in 7 yr 6 mo | U-3867 |
| 11944595 | Nov 01, 2033 | in 7 yr 6 mo | U-3868 |
| 12233035 | Nov 01, 2033 | in 7 yr 6 mo | U-4132 |
| 12280025 | Nov 01, 2033 | in 7 yr 6 mo | U-4168 |
| 12364675 | Nov 01, 2033 | in 7 yr 6 mo | U-3639 |
| 9744144 | Nov 01, 2033 | in 7 yr 6 mo | U-3643 |
| 10130585 | May 09, 2034 | in 8 yr | U-3642 |
