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NORMOCARB HF 25 Drug Patent Profile

When do Normocarb Hf 25 patents expire, and when can generic versions of Normocarb Hf 25 launch?

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

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.

Summary for NORMOCARB HF 25

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	NORMOCARB HF 25 at DailyMed

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

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	5,945,449
Dialysis Sups	NORMOCARB HF 25	magnesium chloride; sodium bicarbonate; sodium chloride	SOLUTION;INJECTION	021910-001	Jul 26, 2006	7,300,674

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
Canada	2365787	SOLUTIONS CONCENTREES STERILES FAIBLES EN BICARBONATE POUR DIALYSE (STERILE LOW BICARBONATE DIALYSIS CONCENTRATE SOLUTIONS)
Australia	2620902
World Intellectual Property Organization (WIPO)	0249693
European Patent Office	1347795

Supplementary Protection Certificates for NORMOCARB HF 25

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	C300517	Netherlands		PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1499331	C300615	Netherlands		PRODUCT NAME: NATRIUMSULFAAT, MAGNESIUMSULFAAT EN KALIUMSULFAAT; NAT. REGISTRATION NO/DATE: RVG 110863 20130417; FIRST REGISTRATION: BE 434323 20130220

NORMOCARB HF 25 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NORMOCARB HF 25

Introduction

NORMOCARB HF 25, a formulation of sodium bicarbonate, is used in various medical applications, including as a pH buffering agent, an electrolyte replenisher, and a systemic alkalizer. To understand the market dynamics and financial trajectory of this drug, it is essential to delve into its uses, market status, and the broader pharmaceutical industry context.

Active Ingredient and Formulation

NORMOCARB HF 25 contains sodium bicarbonate as its active ingredient. Sodium bicarbonate has a molecular formula of CHNaO₃ and is known for its versatility in medical treatments[1].

Medical Uses

Sodium bicarbonate is used in several medical formulations, including those for oral and intravenous administration. It is commonly found in products like Nulytely, which is a solution used for bowel preparation before colonoscopy and other procedures. The drug is also used to treat metabolic acidosis and as an antacid[1].

Market Status

NORMOCARB HF 25, like other sodium bicarbonate formulations, is typically available by prescription. The market status of such drugs can be influenced by factors such as the prevalence of the conditions they treat, competition from other treatments, and regulatory approvals.

Regulatory Environment

The FDA plays a crucial role in the approval and regulation of drugs like NORMOCARB HF 25. The drug development process, which includes preclinical and clinical trials, is rigorous and can take several years. For drugs like sodium bicarbonate, which have been in use for a long time, the focus may be on new formulations or indications rather than initial approval[4].

Orphan Drug Designations

While NORMOCARB HF 25 itself may not be designated as an orphan drug, the strategy of seeking orphan drug designations for other drugs is a significant factor in the pharmaceutical industry. Companies like AbbVie have successfully extended market exclusivity for drugs like Humira by obtaining multiple orphan designations. This strategy can significantly impact the financial trajectory of a drug by extending its monopoly period[2][5].

Financial Impact of Orphan Designations

Orphan drug designations can provide a seven-year exclusivity period, which can be stacked to extend the monopoly period of a drug. For example, Humira, despite being a mass-market drug, has received multiple orphan designations, contributing significantly to its revenue. If a drug like NORMOCARB HF 25 were to be repurposed for rare conditions, it could potentially benefit from similar exclusivity periods, although this is less likely given its current widespread use[2][5].

Competition and Market Share

The market for sodium bicarbonate formulations is competitive, with multiple manufacturers producing similar products. Companies like Braintree, which produces Nulytely, compete based on factors such as formulation, pricing, and distribution networks. The financial trajectory of NORMOCARB HF 25 would depend on its ability to capture and maintain market share in this competitive landscape[1].

Pricing and Revenue

The pricing of NORMOCARB HF 25 is influenced by various factors, including production costs, regulatory approvals, and market demand. While the drug itself may not generate billions of dollars in revenue like blockbuster drugs like Humira, it still contributes significantly to the revenue of its manufacturers. The revenue from such drugs can be substantial, especially if they are widely used in hospitals and clinical settings[2][5].

Industry Trends and Future Outlook

The pharmaceutical industry is constantly evolving, with trends such as personalized medicine, biosimilars, and increased regulatory scrutiny. For drugs like NORMOCARB HF 25, the future outlook may involve innovations in formulation, new indications, and cost-effective production methods to maintain competitiveness.

Impact of Regulatory Changes

Changes in regulatory policies, such as those related to the FDA's approval processes or user fees, can impact the financial trajectory of drugs. For instance, the Prescription Drug User Fee Act and the Medical Device User Fee Modernization Act have imposed fees on manufacturers to fund the FDA's review processes, which can affect the profitability of drugs[4].

Conclusion

The market dynamics and financial trajectory of NORMOCARB HF 25 are influenced by a combination of factors including its medical uses, regulatory environment, competition, and industry trends. While it may not be a blockbuster drug, its widespread use and potential for new formulations or indications make it a significant player in the pharmaceutical market.

Key Takeaways

• Medical Uses: NORMOCARB HF 25 is used as a pH buffering agent, electrolyte replenisher, and systemic alkalizer.
• Regulatory Environment: The drug is regulated by the FDA, with a focus on preclinical and clinical trials.
• Orphan Designations: While not applicable to NORMOCARB HF 25, orphan designations can significantly extend market exclusivity for other drugs.
• Competition and Market Share: The market is competitive, with multiple manufacturers producing similar products.
• Pricing and Revenue: Pricing is influenced by production costs, regulatory approvals, and market demand.
• Industry Trends: The future outlook involves innovations in formulation, new indications, and cost-effective production methods.

FAQs

Q: What is the primary use of NORMOCARB HF 25? A: NORMOCARB HF 25 is primarily used as a pH buffering agent, an electrolyte replenisher, and a systemic alkalizer.

Q: Is NORMOCARB HF 25 an orphan drug? A: No, NORMOCARB HF 25 is not designated as an orphan drug.

Q: How does the FDA regulate drugs like NORMOCARB HF 25? A: The FDA regulates drugs like NORMOCARB HF 25 through a rigorous process involving preclinical and clinical trials before approval.

Q: What is the impact of orphan drug designations on the pharmaceutical industry? A: Orphan drug designations can extend market exclusivity, maximizing the monopoly period and revenue for the drug.

Q: How competitive is the market for sodium bicarbonate formulations? A: The market is highly competitive, with multiple manufacturers producing similar products.

Sources

1. PharmaCompass: Sodium Bicarbonate.
2. KFF Health News: Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies.
3. CRRT Online: AKI&CRRT 2023 Syllabus.
4. JMCP: Review of the Processes for FDA Oversight of Drugs, Medical Devices.
5. California Healthline: Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies.