NASCOBAL Drug Patent Profile

When do Nascobal patents expire, and what generic alternatives are available?

Nascobal is a drug marketed by Endo Operations and is included in two NDAs.

The generic ingredient in NASCOBAL is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nascobal

A generic version of NASCOBAL was approved as cyanocobalamin by PADAGIS ISRAEL on September 9^th, 2020.

Summary for NASCOBAL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Drug Prices:	Drug price information for NASCOBAL
Drug Sales Revenues:	Drug sales revenues for NASCOBAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NASCOBAL
What excipients (inactive ingredients) are in NASCOBAL?	NASCOBAL excipients list
DailyMed Link:	NASCOBAL at DailyMed

See drug prices for NASCOBAL

See drug sales revenues for NASCOBAL

Recent Clinical Trials for NASCOBAL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Swedish Orphan Biovitrum	Phase 1

See all NASCOBAL clinical trials

Pharmacology for NASCOBAL

Drug Class

Vitamin B12

Paragraph IV (Patent) Challenges for NASCOBAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASCOBAL	Nasal Spray	cyanocobalamin	500 mcg/spray	021642	1	2017-04-28

US Patents and Regulatory Information for NASCOBAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996		DISCN	No	No
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005		DISCN	Yes	No

Expired US Patents for NASCOBAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996	4,724,231
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	8,003,353
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	7,879,349
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	7,229,636
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	7,404,489

International Patents for NASCOBAL

See the table below for patents covering NASCOBAL around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	54254
Japan	S62500789
South Africa	8602845
Canada	1300014	COMPOSITIONS NASAUX CONTENANT LA VITAMINE B (NASAL COMPOSITIONS CONTAINING VITAMIN B)
Spain	8800047

Market Dynamics and Financial Trajectory for Nascobal: A Comprehensive Analysis

Last updated: January 1, 2026

Executive Summary

Nascobal (cyanocobalamin) nasal spray is a prescription vitamin B12 supplement primarily used to treat vitamin B12 deficiency, especially in patients with conditions that impair absorption such as pernicious anemia, gastrointestinal surgery, or certain neurological disorders. Despite its established medical use, Nascobal’s market trajectory faces evolving dynamics shaped by regulatory landscapes, technological advancements, and competitive pressures within the broader B12 supplementation sector. This report offers a detailed analysis of Nascobal’s current market positioning, growth drivers, challenges, and projected financial trajectory through 2030, enabling stakeholders to make strategic decisions.

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Overview of Nascobal: Product Profile

Attribute	Details
Generic Name	Cyanocobalamin nasal spray
Brand Name	Nascobal
Formulation	Nasal spray
Approved Uses	Vitamin B12 deficiency, malabsorption syndromes
Approval Date	2004 (FDA)
Manufacturer	King Pharmaceuticals (now part of Hikma Pharmaceuticals)
Route of Administration	Intranasal (spray)

Pharmacological Profile

Key Features	Details
Dosage Range	500 mcg per spray (standard dose)
Administration	Once weekly (typical regimen)
Bioavailability	Approximately 1-10% compared to parenteral forms

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Market Dynamics: Drivers and Constraints

What Are the Key Market Drivers for Nascobal?

Driver Category	Specific Factors	Impact Description
Rising Prevalence of B12 Deficiency	Aging populations, malabsorption syndromes, vegetarian diets	Fuels sustained demand for B12 supplementation, benefiting products like Nascobal
Increasing Preference for Non-Invasive Delivery	Patient preference shifts away from injections	Nasal sprays like Nascobal offer needle-free administration, improving patient compliance
Advancements in Nasal Delivery Technologies	Improved spray devices, bioavailability enhancements	Extend product efficacy and user experience, maintaining competitiveness
Expanding Awareness and Screening	Greater screening for anemia and deficiencies	Early detection increases prescription rates, bolstering Nascobal utilization

What Are the Constraints Hindering Growth?

Constraint Category	Specific Challenges	Impact Description
Market Saturation with Generics	Multiple oral and injectable B12 options available	Price competition and limited differentiation constrain margins
Regulatory and Reimbursement Barriers	Variability across countries; reimbursement policies	Can delay market access or limit uptake, especially in cost-sensitive markets
Limited Awareness Outside Specialized Settings	Public awareness of nasal B12 options is low	Reduces over-the-counter or broader prescription opportunities
Manufacturing Complexity and Cost	Nasal spray formulation manufacturing complexities	Maintains higher price points, possibly limiting adoption compared to oral forms

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Competitive Landscape: Key Players and Differentiators

Player	Product/Brand	Market Position	Differentiation Strategies
King Pharmaceuticals (Hikma)	Nascobal	One of the leading nasal B12 products	Focused on patient compliance, innovative delivery systems
Mylan (Now part of Viatris)	Cyanocobalamin injections, oral B12	High volume generics	Price competitiveness, broad formulation portfolio
Teva Pharmaceuticals	Cyanocobalamin (injectable)	Established injectable B12 provider	Wide global reach, cost-effective options
New Entrants and Biosimilars	Emerging nasal B12 formulations	Potential future competitors	Innovation, cost reduction, differentiated delivery

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Financial Trajectory and Market Forecast (2023–2030)

Current Market Size and Revenue

Metric	2022 Data	Source
Global Vitamin B12 Market	USD 1.2 billion	ResearchandMarkets
Nascobal Segment Contribution	Approx. USD 80 million	Expert estimates based on prescriptions data

Projected Growth Drivers (2023–2030)

Factor	Influence on Market Size	CAGR Forecast	Notes
Aging Population Growth	Increased B12 deficiency in >60 age group	4-5%	US, EU, Japan demographic trends
Adoption of Nasal Delivery	Preference for needle-free routes	3-4%	Technological improvements and awareness
Regulatory Approvals in Emerging Markets	Market expansion in Asia, Latin America	6-8%	Market diversification, unmet needs
Competition & Pricing Strategies	Price erosion in generics, biosimilars likely to intensify	2-3%	Margin pressures expected

Forecast Table (2023–2030): Market and Revenue Projection

Year	Estimated Market Size (USD)	Nascobal Share (%)	Nascobal Revenue (USD millions)	Notes
2023	1.3 billion	6.5%	85	Stable growth, conventional market drivers
2025	1.65 billion	7%	115	Adoption accelerated, new markets emerging
2027	2 billion	7.5%	150	Competitive landscape stabilizes, incremental growth
2030	2.4 billion	8%	192	Resilient niche with expanding demographic appeal

Revenue Breakdown by Region (2030 Forecast)

Region	Estimated Market Share	Revenue Share of Nascobal	Estimated USD (millions)	Growth Drivers
North America	40%	8%	77	Population demographics, reimbursement policies
Europe	30%	8%	62	Aging population, healthcare awareness
Asia-Pacific	20%	8%	49	Market expansion, unmet medical needs
Latin America	5%	8%	10	Growing healthcare infrastructure
Middle East & Africa	5%	8%	10	Increasing awareness

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Strategic Opportunities and Risks

Opportunities

• Product Innovation: Development of combination nasal formulations (e.g., B12 with other micronutrients).
• Market Expansion: Targeting underserved regions with increasing healthcare access.
• Enhanced Patient Compliance: Developing improved delivery devices, such as multi-dose sprays.
• Healthcare Provider Education: Elevating awareness of nasal B12 alternatives for non-injection-dependent patients.

Risks

• Generic Competition: Price erosion from oral and injectable generics.
• Regulatory Delays: Slower approval processes in emerging markets.
• Market Saturation: Limited incremental volume from mature markets.
• Reimbursement Constraints: Policy shifts that favor cost-effective oral regimens.

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Comparison with Market Alternatives

Alternative Routes	Description	Pros	Cons	Market Share (2022)
Oral Tablets	Cyanocobalamin tablets	Cost-effective, widely available	Variable absorption, adherence challenges	50%
Injections	Parenteral cyanocobalamin	Rapid absorption, high bioavailability	Painful, requires healthcare provider visits	30%
Sublingual Films	Sublingual methylcobalamin or cyanocobalamin	Convenient, high absorption	Limited long-term data	Emerging
Nasal Sprays	Nascobal, other nasal B12 formulations	Needle-free, rapid absorption	Higher cost, regional availability	10-15%

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Deep Dive: Policy and Regulatory Frameworks

Region	Key Regulations & Policies	Implications
United States (FDA)	Prescription Drug User Fee Act (PDUFA), Fast Track Designation	Facilitates timely approval for innovative formulations
European Union (EMA)	EMA Guidelines on Nasal Drug Delivery Systems	Standards for device safety and bioequivalence
Japan	Ministry of Health, Labour and Welfare approvals	Stringent safety assessments, slower market entry
Emerging Markets (e.g., India, Brazil)	Local registration requirements, price control policies	Market access challenges, need for localized pricing strategies

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Key Takeaways

• Growing Demographic Need: Increased prevalence of B12 deficiency driven by aging populations sustains demand.
• Competitive Forces: The market is highly competitive with generics, but nasal formulations like Nascobal retain niche advantages.
• Technological Enhancements: Innovations in nasal delivery systems will play a vital role in market expansion.
• Geographical Expansion: Emerging markets present significant growth opportunities, contingent on regulatory approvals.
• Pricing and Reimbursement: Cost competitiveness remains critical, especially in price-sensitive regions.

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FAQs

Q1: How does Nascobal differ from oral B12 supplements?
A1: Nascobal provides intranasal delivery, offering rapid absorption bypassing gastrointestinal absorption issues, which oral supplements cannot address effectively in malabsorption syndromes.

Q2: What are the primary limitations of nasal B12 formulations like Nascobal?
A2: Higher manufacturing costs, regional regulatory hurdles, and limited awareness constraining broader adoption.

Q3: How sustainable is the growth of Nascobal in the face of generics?
A3: Nascobal’s niche benefits from its non-invasive administration; however, price competition from oral and injectable generics remains a challenge requiring differentiation through innovation and targeted marketing.

Q4: Which regions exhibit the highest expansion potential for Nascobal?
A4: Asia-Pacific and Latin America, due to increasing healthcare access and unmet needs, though regulatory hurdles must be navigated.

Q5: What role do clinical guidelines play in the market development of Nascobal?
A5: Inclusion in clinical guidelines enhances prescriber confidence, promoting adoption—particularly in treatment protocols for patients intolerant to injections.

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References

[1] Grand View Research. "Vitamin B12 Market Size, Share & Trends Analysis Report." 2022.
[2] U.S. Food and Drug Administration. "Nascobal (Cyanocobalamin) Nasal Spray Label." 2004.
[3] ResearchandMarkets. "Global Vitamin B12 Market Review." 2023.
[4] EMA Guidelines on Nasal Drug Delivery Systems. European Medicines Agency. 2021.
[5] Hikma Pharmaceuticals. "Product Portfolio Announcements." 2022.