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Last Updated: May 15, 2021

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NORMOCARB HF 25 Drug Profile

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When do Normocarb Hf 25 patents expire, and what generic alternatives are available?

Normocarb Hf 25 is a drug marketed by Dialysis Sups and is included in one NDA. There is one patent protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in NORMOCARB HF 25 is magnesium chloride; sodium bicarbonate; sodium chloride. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium chloride; sodium bicarbonate; sodium chloride profile page.

DrugPatentWatch® Generic Entry Outlook for Normocarb Hf 25

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 4, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NORMOCARB HF 25
International Patents:4
US Patents:1
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
DailyMed Link:NORMOCARB HF 25 at DailyMed
Drug patent expirations by year for NORMOCARB HF 25
DrugPatentWatch® Estimated Generic Entry Opportunity Date for NORMOCARB HF 25
Generic Entry Date for NORMOCARB HF 25*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INJECTION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for NORMOCARB HF 25

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dialysis Sups NORMOCARB HF 25 magnesium chloride; sodium bicarbonate; sodium chloride SOLUTION;INJECTION 021910-001 Jul 26, 2006 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for NORMOCARB HF 25

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1499331 C300615 Netherlands   Get Started for $10 PRODUCT NAME: NATRIUMSULFAAT, MAGNESIUMSULFAAT EN KALIUMSULFAAT; NAT. REGISTRATION NO/DATE: RVG 110863 20130417; FIRST REGISTRATION: BE 434323 20130220
1020461 300482 Netherlands   Get Started for $10 PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
0984957 122012000051 Germany   Get Started for $10 PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
0124495 SPC/GB01/006 United Kingdom   Get Started for $10 PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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