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Last Updated: October 27, 2020

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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.

Drug Prices for potassium chloride

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Drug Sales Revenue Trends for potassium chloride

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Generic filers with tentative approvals for POTASSIUM CHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial20MEQTablet; Oral
  Start Trial  Start Trial10MEQTablet, 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
Anchen Pharms POTASSIUM CHLORIDE potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 202886-002 Dec 26, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc POTASSIUM CHLORIDE potassium chloride FOR SOLUTION;ORAL 210200-001 Nov 23, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
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   Start Trial   Start Trial   Start Trial
Nesher Pharms POTASSIUM CHLORIDE potassium chloride TABLET, EXTENDED RELEASE;ORAL 076044-001 Apr 5, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Icu Medical Inc POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER potassium chloride INJECTABLE;INJECTION 020161-004 Aug 11, 1998 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>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

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

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
McKinsey
Boehringer Ingelheim
Baxter
AstraZeneca

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