potassium chloride - Profile

What are the generic drug sources for potassium chloride and what is the scope of patent protection?

Potassium chloride is the generic ingredient in forty-five branded drugs marketed by Savage Labs, Upsher Smith Labs, Nesher Pharms, Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Chartwell Molecular, Glenmark Pharms Ltd, Granules, Lupin Ltd, Novel Labs Inc, Padagis Us, Ph Health, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Genus, Ajenat Pharms, Amneal, Anda Repository, Epic Pharma Llc, Novitium Pharma, Rubicon Research, Kv Pharm, Abraxis Pharm, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Nexus, Pharma Serve Ny, Watson Labs, Otsuka Icu Medcl, Genus Lifesciences, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Macleods Pharms Ltd, Pharm Assoc, Quagen, Sciegen Pharms, Taro, Wes Pharma Inc, Future Pak, Abbvie, Apothecon, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Pharmobedient, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, and Novartis, and is included in one hundred and thirty-eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are two tentative approvals for this compound.

Summary for potassium chloride

US Patents:	1
Tradenames:	45
Applicants:	65
NDAs:	138

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.

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
Savage Labs	K-LEASE	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	073398-001	Jan 28, 1992		DISCN	No	No
Savage Labs	K-LEASE	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	072427-001	Mar 28, 1990		DISCN	No	No
Upsher Smith Labs	KLOR-CON	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	203106-001	Jul 10, 2015		DISCN	No	No
Upsher Smith Labs	KLOR-CON	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	203106-002	Jul 10, 2015		DISCN	No	No
Nesher Pharms	MICRO-K	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for potassium chloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-002	Jun 13, 1986	4,863,743
Kv Pharm	MICRO-K LS	potassium chloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	019561-003	Aug 26, 1988	4,259,315
Nesher Pharms	MICRO-K	potassium chloride	CAPSULE, EXTENDED RELEASE;ORAL	018238-001	Approved Prior to Jan 1, 1982	4,259,315
Apothecon	KLOTRIX	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	017850-001	Approved Prior to Jan 1, 1982	4,140,756
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-001	Jun 13, 1986	4,863,743