Is there a generic for Colchicine?

Yes. The FDA Orange Book lists 17 approved generic (ANDA) applications for Colchicine, referencing the brand LODOCO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Colchicine?

LODOCO (NDA 215727, AGEPHA PHARMA FZ) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Colchicine?

The Orange Book lists 41 patents against Colchicine products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Colchicine are approved?

Colchicine is approved in the following dosage forms: capsule, solution, tablet.

FDA Orange Book · active-ingredient family

Colchicine

Colchicine: 4 brands, 17 generics; first approved Jul 29, 2009; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 17 ANDA applications approved.

Earliest patent expiry Oct 06, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 06, 2028

in 2 yr 2 mo

Brand (NDA) products

Originator applications

LODOCORLDRS
AGEPHA PHARMA FZNDA 2157272023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx —
GLOPERBARLDRS
SCILEX PHARMSNDA 2109422019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG/5ML SOLUTION ORAL Rx —
MITIGARERLDRS
HIKMA INTL PHARMSNDA 2048202014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG CAPSULE ORAL Rx AB
COLCRYSRLD
TAKEDA PHARMS USANDA 0223522009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG/5ML	SOLUTION	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Discontinued	—

Generic (ANDA) products (17)

Abbreviated applications

COLCHICINE
MICRO LABSANDA 2128802026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG CAPSULE ORAL Rx AB
COLCHICINE
MACLEODS PHARMS LTDANDA 2106332026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINE
ANNORA PHARMAANDA 2176202024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG CAPSULE ORAL Rx AB
COLCHICINE
AUROBINDO PHARMA LTDANDA 2154632024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG CAPSULE ORAL Rx AB
COLCHICINE
GRANULESANDA 2107572024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG CAPSULE ORAL Rx AB
COLCHICINE
STRIDES PHARMAANDA 2091732022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINE
AUROBINDO PHARMA LTDANDA 2154442022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINE
HETERO LABS LTD VANDA 2089932021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINERS
PH HEALTHANDA 2039762021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINE
GRANULESANDA 2104252020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINE
ZYDUS PHARMSANDA 21151920192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
0.3MG TABLET ORAL Rx —
COLCHICINE
MYLANANDA 2094702019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINE
DR REDDYSANDA 2098762019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINE
WATSON LABS INCANDA 2044612019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINE
ALKEM LABS LTDANDA 2112502019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB
COLCHICINE
PH HEALTHANDA 2086782018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG CAPSULE ORAL Rx AB
COLCHICINE
AMNEAL PHARMSANDA 2047112016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.6MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB
0.3MG	TABLET	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.6MG	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7964647	Oct 06, 2028	in 2 yr 2 mo	U-1007
8093297	Oct 06, 2028	in 2 yr 2 mo	U-1161
8097655	Oct 06, 2028	in 2 yr 2 mo	U-1020
8415396	Oct 06, 2028	in 2 yr 2 mo	U-1007
8093296	Oct 06, 2028	in 2 yr 2 mo	U-1007
8093298	Oct 06, 2028	in 2 yr 2 mo	U-1116
8415395	Oct 06, 2028	in 2 yr 2 mo	U-1007
7981938	Oct 06, 2028	in 2 yr 2 mo	U-1166
7964648	Oct 06, 2028	in 2 yr 2 mo	U-1161
7619004	Dec 03, 2028	in 2 yr 4 mo	U-1020
7935731	Dec 03, 2028	in 2 yr 4 mo	U-1116
7601758	Feb 10, 2029	in 2 yr 6 mo	U-1007
7820681	Feb 17, 2029	in 2 yr 7 mo	U-1020
7915269	Feb 17, 2029	in 2 yr 7 mo	U-1007
8440722	Feb 17, 2029	in 2 yr 7 mo	U-1020
7906519	Feb 17, 2029	in 2 yr 7 mo	U-1116
8440721	Feb 17, 2029	in 2 yr 7 mo	U-1007
9555029	Aug 22, 2033	in 7 yr 2 mo	U-1020
9789108	Aug 22, 2033	in 7 yr 2 mo	U-1020
9675613	Aug 22, 2033	in 7 yr 2 mo	U-1020
8927607	Aug 22, 2033	in 7 yr 2 mo	U-1020
9399036	Aug 22, 2033	in 7 yr 2 mo	U-1020
12364675	Nov 01, 2033	in 7 yr 4 mo	U-3639
12233035	Nov 01, 2033	in 7 yr 4 mo	U-4132
11026901	Nov 01, 2033	in 7 yr 4 mo	U-3638
11026900	Nov 01, 2033	in 7 yr 4 mo	U-3639
11026899	Nov 01, 2033	in 7 yr 4 mo	U-3639
10842762	Nov 01, 2033	in 7 yr 4 mo	U-3640
10265281	Nov 01, 2033	in 7 yr 4 mo	U-3639
10206891	Nov 01, 2033	in 7 yr 4 mo	U-3641
9744144	Nov 01, 2033	in 7 yr 4 mo	U-3643
11944594	Nov 01, 2033	in 7 yr 4 mo	U-3864
12280025	Nov 01, 2033	in 7 yr 4 mo	U-4168
11944595	Nov 01, 2033	in 7 yr 4 mo	U-3867
10130585	May 09, 2034	in 7 yr 10 mo	U-3642
12274751	Nov 22, 2036	in 10 yr 5 mo	U-2814
12514819	Nov 22, 2036	in 10 yr 5 mo	U-2814
10383820	Nov 22, 2036	in 10 yr 5 mo	ProductU-2814
10383821	Nov 22, 2036	in 10 yr 5 mo	Product
9907751	Nov 22, 2036	in 10 yr 5 mo	Product
10226423	Dec 20, 2037	in 11 yr 6 mo	Product

Approval history

FDA approval span

First approval

Jul 29, 2009

17 yr 3 mo ago

Most recent approval

Feb 17, 2026

6 mo ago

Approvals span 2009–2026 across 21 FDA applications.

Brand (NDA) 419%

Generic (ANDA) 1781%

Colchicine: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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