Orange Book product · Brand (NDA)
COLCRYS
COLCHICINE
At a glance
Jul 29, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 2009
17 yr 2 mo ago
Today
Patent 7964647 expires
Listed method-of-use patent (U-1007) expiration.
Oct 06, 2028
in 2 yr 4 mo
Patent 7964648 expires
Listed method-of-use patent (U-1161) expiration.
Oct 06, 2028
in 2 yr 4 mo
Patent 7981938 expires
Listed method-of-use patent (U-1166) expiration.
Oct 06, 2028
in 2 yr 4 mo
Patent 8093296 expires
Listed method-of-use patent (U-1007) expiration.
Oct 06, 2028
in 2 yr 4 mo
Patent 8093297 expires
Listed method-of-use patent (U-1161) expiration.
Oct 06, 2028
in 2 yr 4 mo
Patent 8093298 expires
Listed method-of-use patent (U-1116) expiration.
Oct 06, 2028
in 2 yr 4 mo
Patent 8097655 expires
Listed method-of-use patent (U-1020) expiration.
Oct 06, 2028
in 2 yr 4 mo
Patent 8415395 expires
Listed method-of-use patent (U-1007) expiration.
Oct 06, 2028
in 2 yr 4 mo
Patent 8415396 expires
Listed method-of-use patent (U-1007) expiration.
Oct 06, 2028
in 2 yr 4 mo
Patent 7619004 expires
Listed method-of-use patent (U-1020) expiration.
Dec 03, 2028
in 2 yr 6 mo
Patent 7935731 expires
Listed method-of-use patent (U-1116) expiration.
Dec 03, 2028
in 2 yr 6 mo
Patent 7601758 expires
Listed method-of-use patent (U-1007) expiration.
Feb 10, 2029
in 2 yr 8 mo
Patent 7820681 expires
Listed method-of-use patent (U-1020) expiration.
Feb 17, 2029
in 2 yr 8 mo
Patent 7906519 expires
Listed method-of-use patent (U-1116) expiration.
Feb 17, 2029
in 2 yr 8 mo
Patent 7915269 expires
Listed method-of-use patent (U-1007) expiration.
Feb 17, 2029
in 2 yr 8 mo
Patent 8440721 expires
Listed method-of-use patent (U-1007) expiration.
Feb 17, 2029
in 2 yr 8 mo
Patent 8440722 expires
Listed method-of-use patent (U-1020) expiration.
Feb 17, 2029
in 2 yr 8 mo
Pharmaceutical detail
Active ingredient
COLCHICINE
Strength
0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 022352
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.
- 2023LODOCOBrand (NDA)
NDA 215727 · AGEPHA PHARMA FZ
- 2019GLOPERBABrand (NDA)
NDA 210942 · SCILEX PHARMS
- 2014MITIGAREBrand (NDA)
NDA 204820 · HIKMA INTL PHARMS
- 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 (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7964647 | Oct 06, 2028 | in 2 yr 4 mo | U-1007 |
| 7964648 | Oct 06, 2028 | in 2 yr 4 mo | U-1161 |
| 7981938 | Oct 06, 2028 | in 2 yr 4 mo | U-1166 |
| 8093296 | Oct 06, 2028 | in 2 yr 4 mo | U-1007 |
| 8093297 | Oct 06, 2028 | in 2 yr 4 mo | U-1161 |
| 8093298 | Oct 06, 2028 | in 2 yr 4 mo | U-1116 |
| 8097655 | Oct 06, 2028 | in 2 yr 4 mo | U-1020 |
| 8415395 | Oct 06, 2028 | in 2 yr 4 mo | U-1007 |
| 8415396 | Oct 06, 2028 | in 2 yr 4 mo | U-1007 |
| 7619004 | Dec 03, 2028 | in 2 yr 6 mo | U-1020 |
| 7935731 | Dec 03, 2028 | in 2 yr 6 mo | U-1116 |
| 7601758 | Feb 10, 2029 | in 2 yr 8 mo | U-1007 |
| 7820681 | Feb 17, 2029 | in 2 yr 8 mo | U-1020 |
| 7906519 | Feb 17, 2029 | in 2 yr 8 mo | U-1116 |
| 7915269 | Feb 17, 2029 | in 2 yr 8 mo | U-1007 |
| 8440721 | Feb 17, 2029 | in 2 yr 8 mo | U-1007 |
| 8440722 | Feb 17, 2029 | in 2 yr 8 mo | U-1020 |
