Viewing data from:

COLCHICINE

ANDA

COLCHICINE | A210757 | GRANULES PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: MITIGARE(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Hikma Pharmaceuticals USA Inc. et al v. Granules Pharmaceuticals, Inc., USA 1:2018cv00085 5 patentsANDA 210757colchicine	D. Del.	2018-01-12	Terminated 2019-09-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$1.96

per ea

Lowest NADAC/Unit

$1.96

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70010000101COLCHICINE 0.6 MG CAPSULE	$1.96	EA	Generic	—	2026-06-17
70010000103COLCHICINE 0.6 MG CAPSULE	$1.96	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain9 active DMFs6 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

INDENA SPACOLCHICINE USP

DMF 100881993

CHEMPLAST SANMAR LTDCOLCHICINE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 201492007

ALCHEM INTERNATIONAL PRIVATE LTDCOLCHICINE EXTRA PURE GRADE

DMF 225642009

ALKALOIDS BIOACTIVES PRIVATE LTDCOLCHICINE USP (REFINED GRADE)

DMF 241552010

PH HEALTH LTDCOLCHICINE USP

DMF 277222013

HONOUR LAB LIMITEDCOLCHICINE (FORM-A)

DMF 294012015

SOLARA ACTIVE PHARMA SCIENCES LTDCOLCHICINE

DMF 299402015

CHEMICAL RESOURCES (CHERESO)COLCHICINE BP/USP

DMF 320722017

DR WILLMAR SCHWABE INDIA PVT LTDCOLCHICINE USP

DMF 356402021

ROUSSELL UCLAFInactiveCOLCHICINE

DMF 51631983

SM ORGANICS PRIVATE LTDInactiveCOLCHICINE

DMF 117711995

ALCHEM INTERNATIONAL LTDInactiveCOLCHICINE USP

DMF 170032003

ALKALOIDS CORPInactiveCOLCHICINE USP

DMF 180322005

SARV BIO LABS PVT LTDInactiveCOLCHICINE USP

DMF 245252010

VITAL LABORATORIES PVT LTDInactiveCOLCHICINE USP

DMF 247262011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 23, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.6MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 29, 2024

No patent or exclusivity listings for this strength.