Viewing data from:

MITIGARE

NDA

COLCHICINE | N204820 | HIKMA INTERNATIONAL PHARMACEUTICALS LLC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

2033

Today

Aug. 22, 2033

Aug. 22, 2033

Aug. 22, 2033

Aug. 22, 2033

Aug. 22, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Hikma Pharmaceuticals USA Inc. et al v. Micro Labs Ltd. et al 1:2019cv00883 5 patentsANDA 212880colchicine	D. Del.	2019-05-10	Terminated 2020-03-11	—
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	—
Takeda Pharmaceuticals U.S.A., Inc. v. Hikma Pharmaceuticals USA, Inc., et al. 1:2014cv01268 5 patentscolchicine	D. Del.	2014-10-03	Terminated 2018-12-12	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Mitigare (2023)

Total Spending

$25.0M

Total Claims

74,680

Beneficiaries

27,237

Avg Cost/Unit

$6.74

Spending Trend

$9.4M(2019)→$13.0M(2020)→$36.5M(2021)→$37.2M(2022)→$25.0M(2023)

YoY Change:+0.6%

5yr CAGR:+3.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

3 letters from Drugs@FDA

Date	Submission	Document
May 20, 2024	SUPPL -6	View Letter (PDF)
May 3, 2023	SUPPL -4	View Letter (PDF)
Sep 30, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.6MG

RLDAB

5 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 26, 2014

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8927607	Aug 22, 2033	—	—	—	—
9399036	Aug 22, 2033	—	—	—	—
9555029	Aug 22, 2033	—	—	—	—
9675613	Aug 22, 2033	—	—	—	—
9789108	Aug 22, 2033	—	—	—	—