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

2027

2028

2029

2030

2031

2032

2033

2034

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Lodoco (2023)

Total Spending

$46K

Total Claims

Beneficiaries

Avg Cost/Unit

$17.86

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

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)

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	—	—	—	—