Viewing data from:

COMTAN

NDA

ENTACAPONE | N020796 | ORION PHARMA

1 strength0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis NCT06324812	Phase 1/2	Completed	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	128	2024-07-10 → 2026-05-25

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

Medicare Part D Spending

CMS annual spending data for Comtan (2023)

Total Spending

$33K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$7.67

Spending Trend

$16K(2021)→$48K(2022)→$33K(2023)

YoY Change:+0.6%

5yr CAGR:+5.4%

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

API Supply Chain14 active DMFs6 inactive

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

FERMION OYENTACAPONE

DMF 124441997

SUVEN PHARMACEUTICALS LTDENTACAPONE

DMF 190922006

WOCKHARDT LTDENTACAPONE USP

DMF 193852006

SUN PHARMACEUTICAL INDUSTRIES LTDENTACAPONE

DMF 203262007

NEULAND LABORATORIES LTDENTACAPONE USP (FORM-A)

DMF 215262008

DIPHARMA FRANCIS SRLENTACAPONE

DMF 225382009

COHANCE LIFESCIENCES LTDENTACAPONE USP

DMF 239372010

APITORIA PHARMA PRIVATE LTDENTACAPONE USP (NON-STERILE DRUG SUBSTANCE)

DMF 241882010

JUBILANT PHARMOVA LTDENTACAPONE

DMF 243612010

MACLEODS PHARMACEUTICALS LTDENTACAPONE

DMF 254102011

HETERO LABS LTDENTACAPONE

DMF 265012012

HEC PHARM CO LTDENTACAPONE NON-STERILE BULK DRUG SUBSTANCE

DMF 271092013

PIRAMAL PHARMA LTDENTACAPONE

DMF 290102015

SUVEN PHARMACEUTICALS LTDENTACAPONE USP

DMF 333302018

USV LTDInactiveENTACAPONE

DMF 221332008

ARCH PHARMALABS LTDInactiveENTACAPONE

DMF 227142009

RANBAXY LABORATORIES LTDInactiveENTACAPONE

DMF 234122009

STANDARD CHEM AND PHARM CO LTDInactiveENTACAPONE

DMF 238042010

ERREGIERRE SPAInactiveENTACAPONE

DMF 239332010

FIS FABBRICA ITALIANA SINTETICI SPAInactiveENTACAPONE

DMF 239842010

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Feb 24, 2016	SUPPL -26	View Letter (PDF)
Jan 20, 2015	SUPPL -24	View Letter (PDF)
Jun 17, 2014	SUPPL -16	View Letter (PDF)
Oct 13, 2010	SUPPL -15	View Letter (PDF)
Feb 3, 2009	SUPPL -13	View Letter (PDF)
Feb 3, 2009	SUPPL -12	View Letter (PDF)
Dec 30, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 19, 1999

No patent or exclusivity listings for this strength.