NORMOCARB HF 25 Drug Patent 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
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 |

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.
Anatomical Therapeutic Chemical (ATC) Classes for NORMOCARB HF 25
US Patents and Regulatory Information for NORMOCARB HF 25
NORMOCARB HF 25 is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NORMOCARB HF 25 is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting NORMOCARB HF 25
Sterile low bicarbonate dialysis concentrate solutions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION IN CONTINUOUS RENAL REPLACEMENT THERAPY
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 NORMOCARB HF 25
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Dialysis Sups | NORMOCARB HF 25 | magnesium chloride; sodium bicarbonate; sodium chloride | SOLUTION;INJECTION | 021910-001 | Jul 26, 2006 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NORMOCARB HF 25
See the table below for patents covering NORMOCARB HF 25 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1347795 | See Plans and Pricing | |
World Intellectual Property Organization (WIPO) | 0249693 | See Plans and Pricing | |
Australia | 2620902 | See Plans and Pricing | |
Canada | 2365787 | SOLUTIONS CONCENTREES STERILES FAIBLES EN BICARBONATE POUR DIALYSE (STERILE LOW BICARBONATE DIALYSIS CONCENTRATE SOLUTIONS) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NORMOCARB HF 25
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1499331 | 13C0055 | France | See Plans and Pricing | PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220 |
1499331 | SPC/GB13/034 | United Kingdom | See Plans and Pricing | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
0984957 | 122012000017 | Germany | See Plans and Pricing | PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812 |
0984957 | C300483 | Netherlands | See Plans and Pricing | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524 |
0984957 | 122012000051 | Germany | See Plans and Pricing | 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 |
0984957 | CR 2012 00035 | Denmark | See Plans and Pricing | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105 |
1020461 | C300482 | Netherlands | See Plans and Pricing | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |