CHLORAPREP ONE-STEP Drug Patent Profile

When do Chloraprep One-step patents expire, and when can generic versions of Chloraprep One-step launch?

Chloraprep One-step is a drug marketed by Becton Dickinson Co and is included in two NDAs. There are two patents protecting this drug.

This drug has twelve patent family members in eleven countries.

The generic ingredient in CHLORAPREP ONE-STEP is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

DrugPatentWatch^® Generic Entry Outlook for Chloraprep One-step

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CHLORAPREP ONE-STEP

International Patents:	12
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	42
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in CHLORAPREP ONE-STEP?	CHLORAPREP ONE-STEP excipients list
DailyMed Link:	CHLORAPREP ONE-STEP at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for CHLORAPREP ONE-STEP

NDA:

020832

Dosage:

SPONGE;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CHLORAPREP ONE-STEP

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Henry Ford Health System	Phase 4
Gebauer Company	Phase 4
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	N/A

See all CHLORAPREP ONE-STEP clinical trials

Pharmacology for CHLORAPREP ONE-STEP

Physiological Effect

Decreased Cell Wall Integrity

Anatomical Therapeutic Chemical (ATC) Classes for CHLORAPREP ONE-STEP

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B05CA	Antiinfectives
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

D08AC	Biguanides and amidines
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

D09AA	Medicated dressings with antiinfectives
D09A	MEDICATED DRESSINGS
D09	MEDICATED DRESSINGS
D	Dermatologicals

R02AA	Antiseptics
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01AX	Other antiinfectives
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for CHLORAPREP ONE-STEP

CHLORAPREP ONE-STEP is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CHLORAPREP ONE-STEP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP ONE-STEP SEPP	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-001	Oct 7, 2002		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-006	Nov 21, 2006		OTC	Yes	Yes			Y
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-004	Aug 20, 2003		OTC	Yes	Yes

Expired US Patents for CHLORAPREP ONE-STEP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-004	Aug 20, 2003
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-004	Aug 20, 2003
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000

International Patents for CHLORAPREP ONE-STEP

When does loss-of-exclusivity occur for CHLORAPREP ONE-STEP?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

European Patent Office

Japan

Mexico

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CHLORAPREP ONE-STEP around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2002243289
Japan	4435478
Canada	2428099	APPLICATEUR DE LIQUIDE DOTE D'AILERONS DIAMETRALEMENT OPPOSES (LIQUID APPLICATOR WITH DIAMETRICALLY OPPOSED WINGS)
World Intellectual Property Organization (WIPO)	9707729