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KLONOPIN

NDA

CLONAZEPAM | N017533 | CHEPLAPHARM ARZNEIMITTEL GMBH

5 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 Klonopin (2023)

Total Spending

$3.7M

Total Claims

14,976

Beneficiaries

2,481

Avg Cost/Unit

$2.97

Spending Trend

$4.3M(2019)→$4.6M(2020)→$4.4M(2021)→$3.7M(2022)→$3.7M(2023)

YoY Change:+0.8%

5yr CAGR:+0.6%

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

API Supply Chain7 active DMFs3 inactive

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

FIS FABBRICA ITALIANA SINTETICI SPACLONAZEPAM

DMF 75051988

CAMBREX PROFARMACO MILANO SRLCLONAZEPAM

DMF 113511995

PH HEALTH LTDCLONAZEPAM

DMF 162452002

SUN PHARMACEUTICAL INDUSTRIES LTDCLONAZEPAM USP

DMF 177272004

APOTEX PHARMACHEM INDIA PVT LTDCLONAZEPAM USP

DMF 221672008

CENTAUR PHARMACEUTICALS PVT LTDCLONAZEPAM USP

DMF 225802009

R L FINE CHEM PVT LTDCLONAZEPAM

DMF 380702023

DIOSYNTH BVInactiveCLONAZEPAM

DMF 86781990

HOECHST CELANESE CORPInactiveCLONAZEPAM

DMF 118971996

LAKE CHEMICALS PRIVATE LTDInactiveCLONAZEPAM

DMF 225832009

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2023	SUPPL -62	View Letter (PDF)
Feb 9, 2021	SUPPL -61	View Letter (PDF)
Oct 30, 2017	SUPPL -59	View Letter (PDF)
Dec 22, 2016	SUPPL -58	View Letter (PDF)
Mar 29, 2016	SUPPL -55	View Letter (PDF)
Nov 6, 2013	SUPPL -53	View Letter (PDF)
Jun 4, 2012	SUPPL -46	View Letter (PDF)
Dec 14, 2011	SUPPL -52	View Letter (PDF)
Sep 21, 2010	SUPPL -48	View Letter (PDF)
May 1, 2009	SUPPL -45	View Letter (PDF)
Jan 29, 2002	SUPPL -37	View Letter (PDF)
Jan 22, 2001	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 0.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 1MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 2MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#005 — 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 9, 1997

#006 — 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 9, 1997