POTASSIUM CHLORIDE Drug Patent Profile

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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, Adaptis, Ajenat Pharms, Amneal, 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, 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-six NDAs. There are two patents protecting this drug.

The generic ingredient in POTASSIUM CHLORIDE is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. 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:	2
Applicants:	59
NDAs:	136

US Patents and Regulatory Information for POTASSIUM CHLORIDE

POTASSIUM CHLORIDE is protected by two 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
Granules	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	213392-002	Jan 29, 2021	AA	RX	No	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

Supplementary Protection Certificates for POTASSIUM CHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
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;
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
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
1441735	SPC/GB08/020	United Kingdom		PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102