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Potassium chloride - Generic Drug Details

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What are the generic drug sources for potassium chloride and what is the scope of freedom to operate?

Potassium chloride is the generic ingredient in forty-two branded drugs marketed by Savage Labs, Upsher Smith Labs, Nesher Pharms, Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Anchen Pharms, Glenmark Pharms Ltd, Lannett Co Inc, Lupin Ltd, Novel Labs Inc, Paddock Llc, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Amneal, Belcher, Epic Pharma Llc, Pharma Res Software, Kv Pharm, Abraxis Pharm, Akorn, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Pharma Serve Ny, Watson Labs, Icu Medical Inc, Apotex, Genus Lifesciences, Pharm Assoc, Future Pak, Abbvie, Apothecon, Aurobindo Pharma Ltd, Centaur Pharms Pvt, Copley Pharm, Granules Pharms, Mylan, Paddock Labs Llc, Schering, Sigmapharm Labs Llc, Vitruvias Therap, Yichang Humanwell, and Novartis, and is included in one hundred and five NDAs. Additional information is available in the individual branded drug profile pages.

There are two hundred and forty drug master file entries for potassium chloride. Seventy-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for potassium chloride

US Patents:	0
Tradenames:	42
Applicants:	53
NDAs:	105
Drug Master File Entries:	240
Suppliers / Packagers:	79
Bulk Api Vendors:	248
Patent Applications:	300
Drug Prices:	Drug price trends for potassium chloride
Drug Sales Revenues:	Drug sales revenues for potassium chloride
DailyMed Link:	potassium chloride at DailyMed

See drug prices for potassium chloride

See drug sales revenues for potassium chloride

Generic filers with tentative approvals for POTASSIUM CHLORIDE

Applicant	Application No.	Strength	Dosage Form
		20MEQ	Tablet; Oral
		10MEQ	Tablet, Extended Release; Oral

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for potassium chloride

Drug Class	Potassium Salt Osmotic Laxative
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

US Patents and Regulatory Information for potassium chloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anchen Pharms	POTASSIUM CHLORIDE	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	202886-002	Dec 26, 2013	AB	RX	No	No
Epic Pharma Llc	POTASSIUM CHLORIDE	potassium chloride	FOR SOLUTION;ORAL	210200-001	Nov 23, 2018	AA	RX	No	No
Baxter Hlthcare	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	potassium chloride; sodium chloride	INJECTABLE;INJECTION	017648-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	No
Nesher Pharms	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	076044-001	Apr 5, 2002		DISCN	No	No
Icu Medical Inc	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	potassium chloride	INJECTABLE;INJECTION	020161-004	Aug 11, 1998	AP	RX	Yes	Yes

Expired US Patents for potassium chloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apothecon	KLOTRIX	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	017850-001	Approved Prior to Jan 1, 1982
Nesher Pharms	MICRO-K	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-001	Approved Prior to Jan 1, 1982
Kv Pharm	MICRO-K LS	potassium chloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	019561-003	Aug 26, 1988
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-001	Jun 13, 1986
Nesher Pharms	MICRO-K 10	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-002	May 14, 1984