Potassium chloride - Generic Drug Details

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-four 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, Granules, Lannett Co Inc, Lupin Ltd, Novel Labs Inc, Padagis Us, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Amneal, Belcher, Epic Pharma Llc, Pharma Res Software, Rubicon, 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, Nexus Pharms, Icu Medical Inc, Apotex, Genus Lifesciences, Pharm Assoc, Saptalis Pharms, Wes Pharma Inc, Future Pak, Abbvie, Apothecon, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Breckenridge, Copley Pharm, Guangzhou Novaken, Mylan, Schering, Sigmapharm Labs Llc, Vitruvias Therap, Yichang Humanwell, and Novartis, and is included in one hundred and twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for potassium chloride. Eighty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for potassium chloride

US Patents:	0
Tradenames:	44
Applicants:	59
NDAs:	123
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	86
Raw Ingredient (Bulk) Api Vendors:	333
Patent Applications:	300
Drug Prices:	Drug price trends for potassium chloride
Drug Sales Revenues:	Drug sales revenues for potassium chloride
What excipients (inactive ingredients) are in potassium chloride?	potassium chloride excipients list
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	Osmotic Laxative Potassium Salt
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
Padagis Us	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	205993-001	Nov 5, 2015	AB2	RX	No	No
Prinston Inc	POTASSIUM CHLORIDE	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	209026-002	Jun 11, 2019	AB	RX	No	No
B Braun	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	potassium chloride; sodium chloride	INJECTABLE;INJECTION	018722-004	Nov 9, 1982		DISCN	No	No
B Braun	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	potassium chloride; sodium chloride	INJECTABLE;INJECTION	018722-002	Nov 9, 1982		DISCN	No	No

Expired US Patents for potassium chloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nesher Pharms	MICRO-K	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-001	Approved Prior to Jan 1, 1982
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-002	Jun 13, 1986
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