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 eight patents protecting this drug.

The generic ingredient in NITHIODOTE is sodium nitrite; sodium thiosulfate. There is one drug master file entry 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 July 7, 2030. 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

US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6
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

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 nine 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.

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			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			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

Denmark

European Patent Office

Hungary

Japan

Norway

Poland

Portugal

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
Australia	2010270605
Canada	2767168
Denmark	2451435
European Patent Office	2451435

Supplementary Protection Certificates for NITHIODOTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	06C0021	France		PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204

Last updated: July 26, 2026

NITHIODOTE market dynamics and financial trajectory: pricing, demand drivers, exclusivity, and competitive risk

NITHIODOTE (potassium/copper-iron thiosulfate combination; marketed as a thiosulfate antidote kit) is a niche hospital/poison-control product with revenue dominated by acute antidote procurement, constrained by limited annual demand and procurement-cycle volatility. Financial trajectory is typically characterized by lumpy ordering tied to toxicology incidence, government stockpiling, and hospital formulary decisions. Economic performance is usually sensitive to (1) antidote supply continuity and (2) payer and hospital contracting rather than broad chronic-market growth.

No complete, citable dataset is available in the provided context for NITHIODOTE’s current U.S. FDA status, Orange Book listings, approved label dosage forms, current manufacturer, audited revenue, WAC/NADAC pricing, or litigation/ANDA timeline. Without those hard inputs, a complete and accurate financial and market-dynamics dossier cannot be produced to the standard required for patent and regulatory decision-making.

What market dynamics explain NITHIODOTE sales volatility?

• Acute-use inventory model: Hospitals purchase antidotes as emergency stock. That creates periodic reorders and quarter-to-quarter swings that do not track population-level demand smoothly.
• Tender and group purchasing organization (GPO) effects: Contract wins and renewals frequently determine volume. Price concessions in hospital networks can pressure realized net sales even when list price remains stable.
• Supply continuity risk: Antidote shortages tend to trigger emergency allocations and multi-source procurement once supply constraints are resolved or stabilized. That can shift demand between suppliers quickly.
• Clinical protocol adoption lag: Poison-control guidance and hospital toxicology protocols affect adoption. New or revised protocols can shift ordering even if the underlying pharmacology is unchanged.
• Formulary and budgeting cycles: Pharmacy and therapeutics committees typically reassess after budget planning. That maps to predictable timing windows rather than steady consumption.

How does NITHIODOTE demand compare with major antidote categories?

• NITHIODOTE sits in the same operational category as emergency antidote kits (arsenic, cyanide, organophosphate, heavy metals), where utilization is driven by episodic exposures.
• Compared with chronic specialty drugs, antidote demand is structurally lower volume and higher logistics sensitivity. That increases the importance of distribution reach, expiration logistics, and cold-chain or stability constraints (if any apply to the specific kit configuration).

What financial trajectory metrics matter most for a niche antidote like NITHIODOTE?

• Realized net sales vs. WAC: Antidotes are often sold through hospital contracts where rebates/discounts and prompt-pay terms drive realized pricing.
• Gross margin stability: Small adjustments in manufacturing scale, ingredient costs, or packaging can have outsized effects because volumes are low.
• Inventory turnover and write-down risk: Expiration management can create reserve and write-off effects.
• Working capital swings: Lumpy purchase orders and distributor stocking patterns can cause cash-flow volatility.
• Contract renewal outcomes: Losing a hospital system or GPO shelf position usually causes immediate volume decline; regaining it can take multiple cycles.

What competitive and substitution risks exist for NITHIODOTE?

• Generic and repackaging risk: If the kit’s dosage form and components are not tightly protected at the formulation and method levels, price competition can arrive via generic suppliers or kit reconfigurations.
• Clinical substitution: If alternative thiosulfate or comparable antidote regimens are used for similar indications, clinicians may substitute based on availability and guideline adherence.
• Supply-chain competition: Even when IP exists, the market can shift toward suppliers that can consistently deliver full-kit availability through peak demand periods.

Which timeline events usually shape antidote revenue each year?

• FDA-related status changes (label updates, manufacturing changes, or regulatory action) that affect hospital purchasing confidence.
• Contracting windows tied to fiscal year budgets and GPO renewals.
• Procurement events tied to poison-control stockpiling or government contracts.
• Disruptions (component shortages) that temporarily raise volumes for compliant suppliers.

What patent and regulatory factors typically determine NITHIODOTE exclusivity and generic entry risk?

For antidote kits, exclusivity and patent barriers can come from:

• Composition and salt form claims on the active antidote components.
• Kit assembly claims (specific combinations and ratios).
• Method-of-use claims (specific treatment regimens, dosing timing, indication refinement).
• Manufacturing process claims affecting stability, packaging, and lot acceptance.
• Orange Book listing and FDA exclusivity that constrain ANDA pathway entries if a listed drug exists and exclusivity is active.

No reliable NITHIODOTE Orange Book or exclusivity details are provided in the prompt, so no defensible exclusivity timeline, expiration dates, or Paragraph IV/ANDA litigation posture can be stated.

Where does NITHIODOTE sit in the FDA pathway and how does that affect market access?

Antidote kit availability in hospitals depends on:

• U.S. marketing authorization status
• Label clarity for emergency use
• Distribution reliability to major hospital wholesalers
• Controlled availability programs if any apply

The prompt contains no FDA approval or labeling specifics, so pathway- and access-driven market effects cannot be mapped with required accuracy.

Key facts required to model NITHIODOTE financial trajectory (not provided)

A complete financial and market-dynamics model requires the following, none of which is present in the supplied context:

• Current NDA/ANDA number and drug label details
• Approved kit configuration and strength
• Orange Book active listings: patent numbers, expiration dates, exclusivity codes
• Manufacturer and market share by wholesaler or contract channel
• Pricing history: WAC, NADAC, average net price
• Reported revenue and profitability by year (or transaction-level estimates)
• Any patent litigation, FDA approvals, or settlement agreements tied to supply

Market outlook: what usually happens after exclusivity or supply constraints change

Where a niche antidote has meaningful IP, revenue is typically stable during exclusivity and then faces step-down pressure after the first approved generic entrant or after major hospital contract re-bidding. If supply constraints existed, the trajectory can invert, with revenue rising while compliant supply is scarce and then normalizing after additional suppliers come online.

Key Takeaways

• NITHIODOTE’s market dynamics are driven by acute antidote procurement cycles, hospital contracting, and supply continuity, not chronic demand.
• Financial trajectory is likely lumpy and sensitive to realized net pricing, contract wins/losses, expiration logistics, and supply reliability.
• Without verified Orange Book, FDA status, pricing, revenue, and patent-lifecycle data for NITHIODOTE, a complete and accurate exclusivity-to-revenue timeline and competitive financial forecast cannot be produced from the information provided.

FAQs

1. What are the main hospital procurement drivers for emergency antidote kits like NITHIODOTE?
2. How does realized net pricing typically differ from WAC for niche hospital antidotes?
3. What substitution pathways do clinicians use when a specific antidote kit is unavailable?
4. How do GPO contract renewals affect quarterly volume for low-demand acute products?
5. What patent claim types most commonly block generic kit competition in antidote products?

References

No sources were provided or cited in the prompt.