POTASSIUM CHLORIDE Drug Patent Profile

When do Potassium Chloride patents expire, and when can generic versions of Potassium Chloride launch?

Potassium Chloride is a drug marketed by Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Chartwell Molecular, Glenmark Pharms Ltd, Granules, Lupin, Nesher Pharms, Novel Labs Inc, Padagis Us, Ph Health, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Ajenat Pharms, Amneal, Anda Repository, Epic Pharma Llc, Genus, Novitium Pharma, Rubicon Research, Abraxis Pharm, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Nexus, Pharma Serve Ny, Watson Labs, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Genus Lifesciences, Macleods Pharms Ltd, Pharm Assoc, Quagen, Sciegen Pharms, Taro, Wes Pharma Inc, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Pharmobedient, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, Otsuka Icu Medcl, and Icu Medical Inc. and is included in one hundred and thirty-seven NDAs. There is one patent protecting this drug.

The generic ingredient in POTASSIUM CHLORIDE is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.

DrugPatentWatch^® Generic Entry Outlook for Potassium Chloride

Annual sales in 2022 were $9mm indicating the motivation for generic entry (peak sales were $386mm in 2004).

Indicators of Generic Entry

Summary for POTASSIUM CHLORIDE

US Patents:	1
Applicants:	59
NDAs:	137

US Patents and Regulatory Information for POTASSIUM CHLORIDE

POTASSIUM CHLORIDE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	018008-004	Approved Prior to Jan 1, 1982		RX	No	No
Luitpold	POTASSIUM CHLORIDE	potassium chloride	INJECTABLE;INJECTION	087585-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Otsuka Icu Medcl	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	potassium chloride	INJECTABLE;INJECTION	020161-005	Nov 30, 1992	AP	RX	Yes	Yes
B Braun	POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	019630-028	Feb 17, 1988	AP	RX	No	No
Macleods Pharms Ltd	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	218733-002	Sep 10, 2025	AA	RX	No	No
B Braun	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	019630-011	Feb 17, 1988		RX	No	No
Abraxis Pharm	POTASSIUM CHLORIDE	potassium chloride	INJECTABLE;INJECTION	080204-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

International Patents for POTASSIUM CHLORIDE

See the table below for patents covering POTASSIUM CHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	52918
Australia	5514086
Australia	583903
Canada	1270765	CHLORURE DE POTASSIUM A LIBERATION CONTROLEE (CONTROLLED RELEASE POTASSIUM CHLORIDE)
Germany	3671373
Denmark	165123
Denmark	494986

Supplementary Protection Certificates for POTASSIUM CHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0733366	SPC/GB98/031	United Kingdom		PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
1718641	2012/008	Ireland		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1718641	SPC/GB12/028	United Kingdom		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215