NITHIODOTE Drug Patent Profile

Which patents cover Nithiodote, and when can generic versions of Nithiodote launch?

Nithiodote is a drug marketed by Hope Pharms and is included in one NDA. There are seven patents protecting this drug.

This drug has fifty-seven patent family members in fifteen countries.

The generic ingredient in NITHIODOTE is sodium nitrite; sodium thiosulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite; sodium thiosulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nithiodote

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 24, 2031. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NITHIODOTE

International Patents:	57
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NITHIODOTE
What excipients (inactive ingredients) are in NITHIODOTE?	NITHIODOTE excipients list
DailyMed Link:	NITHIODOTE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NITHIODOTE

Constraining patent/regulatory exclusivity:

8,568,793

NDA:

201444

Dosage:

SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS

^*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 NITHIODOTE

NITHIODOTE is protected by eight US patents.

This potential generic entry date is based on patent 8,568,793.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	8,496,973		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	9,585,912		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	9,687,506		Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	8,568,793		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	11,753,301		Y	Y

International Patents for NITHIODOTE

When does loss-of-exclusivity occur for NITHIODOTE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NITHIODOTE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	7629976
Japan	2020011992	チオ硫酸ナトリウムを含有する薬学的組成物 (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Japan	2019048852	チオ硫酸ナトリウムを含有する薬学的組成物 (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Japan	7408753
Poland	2395834

Supplementary Protection Certificates for NITHIODOTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
0290047	97C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
2666774	CA 2020 00037	Denmark		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
0957929	SPC/GB06/021	United Kingdom		PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115

Market Dynamics and Financial Trajectory for Nithiodote

Introduction

Nithiodote, a combination product consisting of sodium nitrite and sodium thiosulfate, is a critical medication approved for the treatment of acute cyanide poisoning. Here, we delve into the market dynamics and financial trajectory of this life-saving drug.

Regulatory History

Nithiodote was initially approved by the FDA on January 14, 2011, as a combination product under NDA 201444. This approval was based on a 505(b)(2) application, referencing an earlier NDA held by the Department of the Army[1].

Market Flexibility and Supply Management

The initial approval required the two components to be marketed together in a single package, which posed logistical challenges due to different expiry dates for each component. To address this, Hope Pharmaceuticals submitted separate 505(b)(2) applications for sodium nitrite and sodium thiosulfate, allowing these components to be marketed individually. This change increased flexibility for users, such as hospitals and the military, in managing their supply stocks[1].

Post-Marketing Requirements and Commitments

As part of the approval, Hope Pharmaceuticals was required to fulfill several post-marketing requirements and commitments. These included non-clinical studies to assess leachables from the product packaging and extractable studies on the rubber stopper and vial. The company fulfilled these requirements and submitted information to address the need for alternative container closure systems and sterilization methods[1].

Patent and Exclusivity

Hope Pharmaceuticals received a U.S. patent (No. 8,568,793) for sodium nitrite-containing pharmaceutical compositions, which is set to expire in December 2031. This patent covers the active pharmaceutical ingredient, its formulation, and use in Nithiodote and Sodium Nitrite Injection products. The exclusivity provided by this patent is crucial for the company's market position[5].

Market Exclusivity and Monopoly Strategies

While Nithiodote's approval does not involve orphan drug designations, the strategies employed by other pharmaceutical companies to extend market exclusivity through multiple orphan approvals are noteworthy. Companies like AbbVie and Sigma-Tau Pharmaceuticals have used orphan designations to extend their market monopolies, a tactic that could be observed in other pharmaceutical markets but is not directly applicable to Nithiodote[2][4].

Financial Impact

The financial trajectory of Nithiodote is influenced by its unique market position and the critical nature of the treatment it provides. As the sole supplier of Sodium Nitrite Injection in the United States, Hope Pharmaceuticals enjoys a monopoly in this niche market. The ability to market the components separately has likely reduced costs associated with replacing entire packages and minimized waste, which could contribute to higher profitability[1].

Revenue and Market Share

While specific revenue figures for Nithiodote are not publicly disclosed, the drug's critical role in treating acute cyanide poisoning ensures a steady demand. The patent exclusivity until 2031 protects Hope Pharmaceuticals' market share, allowing the company to maintain a significant revenue stream from this product.

Competitive Landscape

The competitive landscape for Nithiodote is limited due to its specialized use and the absence of direct competitors. Hope Pharmaceuticals' exclusive patent and FDA approval ensure that the company remains the sole provider of this life-saving medication in the U.S. market[5].

Consumer and Healthcare Provider Perspectives

For consumers and healthcare providers, Nithiodote's availability is crucial due to its life-saving potential. The flexibility in managing supply stocks, thanks to the separate marketing of components, is a significant advantage. This flexibility reduces the likelihood of stockouts and ensures that critical care facilities always have access to the medication[1].

Regulatory Oversight and Future Directions

The FDA's regulatory oversight ensures that Nithiodote meets stringent safety and efficacy standards. Future directions may include further research into alternative formulations or delivery methods, but any changes would need to adhere to the FDA's regulatory framework. The agency's focus on ensuring the safety and efficacy of pharmaceutical products will continue to shape the market dynamics for Nithiodote[1].

Key Takeaways

• Regulatory Approval: Nithiodote was approved by the FDA in 2011 as a combination product and later as separate components.
• Market Flexibility: Separate marketing of sodium nitrite and sodium thiosulfate increased supply management flexibility.
• Patent Exclusivity: Hope Pharmaceuticals holds a U.S. patent until 2031, ensuring market exclusivity.
• Financial Impact: Monopoly in the U.S. market and reduced waste contribute to profitability.
• Competitive Landscape: Limited competition due to specialized use and patent protection.

FAQs

What is Nithiodote used for?

Nithiodote is used for the treatment of acute cyanide poisoning that is judged to be life-threatening.

Who is the sole supplier of Sodium Nitrite Injection in the U.S.?

Hope Pharmaceuticals is the sole supplier of Sodium Nitrite Injection in the United States.

What is the significance of the U.S. patent for Nithiodote?

The U.S. patent (No. 8,568,793) provides exclusivity for Hope Pharmaceuticals until December 2031, protecting their market position.

How has the separate marketing of Nithiodote components affected supply management?

The separate marketing of sodium nitrite and sodium thiosulfate has increased flexibility for users, reducing the need to replace entire packages when only one component reaches its expiry date.

What are the post-marketing requirements and commitments for Nithiodote?

The post-marketing requirements include non-clinical studies on leachables and extractable studies on packaging components. The commitments involve evaluating alternative container closure systems and sterilization methods.

Sources

1. FDA Summary Review for Regulatory Action: NDA 203923 Sodium thiosulfate injection, USP[1].
2. KHN Health News: Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies[2].
3. GAO Report: ORPHAN DRUGS: FDA Should Ensure Designation Process Is Transparent and Consistent[3].
4. California Healthline: Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies[4].
5. Biospace: Hope Pharmaceuticals Receives U.S. Patent for Medications Containing Sodium Nitrite[5].