NORMOCARB HF 25 Drug Patent Profile

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

NDA:

021910

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

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CC	Magnesium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

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

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

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 NORMOCARB HF 25

NORMOCARB HF 25 is protected by one US patents.

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

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			Y

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

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
World Intellectual Property Organization (WIPO)	0249693
Australia	2620902
Canada	2365787	SOLUTIONS CONCENTREES STERILES FAIBLES EN BICARBONATE POUR DIALYSE (STERILE LOW BICARBONATE DIALYSIS CONCENTRATE SOLUTIONS)

Supplementary Protection Certificates for NORMOCARB HF 25

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	13C0055	France		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		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		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		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
0984957	122012000051	Germany		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		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		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105