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

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

Summary for potassium chloride

US Patents:	0
Tradenames:	45
Applicants:	64
NDAs:	132
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	88
Raw Ingredient (Bulk) Api Vendors:	314
Patent Applications:	5,871
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

Drug Sales Revenue Trends for potassium chloride

See drug sales revenues for potassium chloride

Generic filers with tentative approvals for POTASSIUM CHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	20MEQ	Tablet; Oral
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for potassium chloride

A12BA	Potassium
A12B	POTASSIUM
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for potassium chloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tris Pharma Inc	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	214076-001	Jan 26, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	POTASSIUM CHLORIDE	potassium chloride	INJECTABLE;INJECTION	086713-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	potassium chloride	INJECTABLE;INJECTION	019904-001	Dec 26, 1989	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for potassium chloride

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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	⤷ Sign Up	⤷ Sign Up
Schering	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	019439-001	Jun 13, 1986	⤷ Sign Up	⤷ Sign Up
Apothecon	KLOTRIX	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	017850-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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