Viewing data from:

LODOCO

NDA

COLCHICINE | N215727 | AGEPHA PHARMA FZ LLC

1 strength13 unique patents0 unique exclusivities

Patent Timeline

13 unique patents by expiration date

Active (13)Today

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Today

Nov. 1, 2033

May. 9, 2034

Nov. 1, 2033

Nov. 1, 2033

Nov. 1, 2033

Nov. 1, 2033

Nov. 1, 2033

Nov. 1, 2033

Nov. 1, 2033

Nov. 1, 2033

Nov. 1, 2033

Nov. 1, 2033

Nov. 1, 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

129 trials from ClinicalTrials.gov — 2 recruiting, 89 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Randomized Multicenter Study for Isolated Skin Vasculitis NCT02939573	Phase 2	Recruiting	University of Pennsylvania	90	2017-01-01 → 2028-12-31
PET Imaging of Inflammation and Lipid Lowering Study NCT04073797	N/A	Recruiting	University of Cambridge	63	2023-03-20 → 2026-03-01
Study of Colchicine to Prevent the Postpericardiotomy Syndrome NCT00128427	Phase 3	Completed	Azienda Sanitaria Locale 3, Torino	360	2005-06 → 2010-06
Colchicine for Symptom and Inflammation in Knee Osteoarthritis NCT02176460	Phase 2/3	Completed	Singapore General Hospital	109	2013-10 → 2015-09
Inflammation and Coronary Endothelial Function NCT02366091	Phase 2	Completed	Johns Hopkins University	111	2015-01 → 2020-09-01
Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI Pilot)NCT04160117	Phase 3	Completed	Population Health Research Institute	202	2020-01-14 → 2022-05-30
Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis NCT03128905	Phase 3	Completed	Lille Catholic University	111	2018-02-05 → 2022-05-13
Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease NCT00700297	Phase 2	Completed	Tehran University of Medical Sciences	169	2002-08 → 2006-05
Drug-Drug Interaction Between Colchicine and Verapamil ER NCT00983242	Phase 1	Completed	Mutual Pharmaceutical Company, Inc.	24	2008-09 → 2008-10
Drug-Drug Interaction Between Colchicine and Ritonavir NCT00983515	Phase 1	Completed	Mutual Pharmaceutical Company, Inc.	24	2008-07 → 2008-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$17.00

per ea

Lowest NADAC/Unit

$17.00

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82867000101LODOCO 0.5 MG TABLET	$17.00	EA	Brand	—	2025-12-29

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$370.39

Highest Price

$370.39

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82867-0001-01LODOCO 0.5MG TAB	$370.39	FSS	Agepha Pharma USA, LLC	05/31/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Lodoco (2024)

Total Spending

$606K

Total Claims

723

Beneficiaries

294

Avg Cost/Unit

$15.74

Spending Trend

$46K(2023)→$606K(2024)

YoY Change:-11.9%

5yr CAGR:-11.9%

Source: CMS Medicare Part D Spending by Drug (2024). 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

1 letter from Drugs@FDA

Date	Submission	Document
Jun 20, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG

RLD

13 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 16, 2023

Patents (13) · 14 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9744144	Nov 1, 2033	—	—	—	—
10130585	May 9, 2034	—	—	—	—
10206891	Nov 1, 2033	—	—	—	—
10265281	Nov 1, 2033	—	—	—	—
10842762	Nov 1, 2033	—	—	—	—
11026899	Nov 1, 2033	—	—	—	—
11026900	Nov 1, 2033	—	—	—	—
11026901	Nov 1, 2033	—	—	—	—
11944594	Nov 1, 2033	—	—	—	—
11944595	Nov 1, 2033	—	—	—	—
12233035	Nov 1, 2033	—	—	—	—
12280025	Nov 1, 2033	—	—	—	—
12364675	Nov 1, 2033	—	—	—	—