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COLCHICINE

ANDA

COLCHICINE | A211519 | ZYDUS PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
TAKEDA PHARMACEUTICALS U.S.A., INC. v. ZYDUS PHARMACEUTICALS (USA) INC. et al 3:2018cv04591 17 patentsANDA 211519colchicine, USP	D.N.J.	2018-03-28	Terminated 2018-10-25	—

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

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
May 15, 2020	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 0.6MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 19, 2019

No patent or exclusivity listings for this strength.

#002 — 0.3MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 14, 2019