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ANAFRANIL

NDA

CLOMIPRAMINE HYDROCHLORIDE | N019906 | SPECGX LLC

3 strengths0 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

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 Anafranil (2023)

Total Spending

$1.1M

Total Claims

230

Beneficiaries

Avg Cost/Unit

$37.47

Spending Trend

$1.5M(2019)→$1.4M(2020)→$1.3M(2021)→$1.4M(2022)→$1.1M(2023)

YoY Change:+0.2%

5yr CAGR:+1.0%

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

API Supply Chain7 active DMFs2 inactive

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

LUNDBECK PHARMACEUTICALS ITALY SPACLOMIPRAMINE HYDROCHLORIDE

DMF 88641990

SIGMA ALDRICH IRELAND LTDCLOMIPRAMINE HYDROCHLORIDE

DMF 109491994

TARO PHARMACEUTICAL INDUSTRIES LTDCLOMIPRAMINE HYDROCHLORIDE USP

DMF 130211998

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCLOMIPRAMINE HYDROCHLORIDE

DMF 308142016

RL FINE CHEM PVT LTDCLOMIPRAMINE HYDROCHLORIDE

DMF 319422017

SUN PHARMACEUTICAL INDUSTRIES LTDCLOMIPRAMINE HYDROCHLORIDE USP

DMF 329962018

MANKIND PHARMA LTDCLOMIPRAMINE HYDROCHLORIDE USP

DMF 349352020

IROPHARM LTDInactiveCLOMIPRAMINE HYDROCHLORIDE

DMF 80471989

EVONIK TECHNOCHEMIE GMBHInactiveCLOMIPRAMINE HYDROCHLORIDE

DMF 131271998

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
May 14, 2019	SUPPL -43	View Letter (PDF)
Aug 27, 2018	SUPPL -41	View Letter (PDF)
May 25, 2017	SUPPL -40	View Letter (PDF)
Jul 29, 2014	SUPPL -39	View Letter (PDF)
Jul 11, 2014	SUPPL -38	View Letter (PDF)
Oct 29, 2012	SUPPL -37	View Letter (PDF)
Jul 24, 2007	SUPPL -34	View Letter (PDF)
Jan 13, 2005	SUPPL -32	View Letter (PDF)
Sep 7, 2004	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 29, 1989

No patent or exclusivity listings for this strength.

#002 — 50MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 29, 1989

#003 — 75MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 29, 1989