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. There are six patents protecting this drug and one Paragraph IV challenge.

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:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1
Patent Applications:	57
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

NASCOBAL is protected by six US patents.

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	7,404,489		Y
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005		DISCN	Yes	No	8,940,714
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005		DISCN	Yes	No	7,879,349		Y
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005		DISCN	Yes	No	8,003,353
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005		DISCN	Yes	No	7,229,636		Y
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005		DISCN	Yes	No	9,415,007

Expired US Patents for NASCOBAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	9,415,007
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	8,940,714
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
Spain	8800047
Spain	553999
Germany	3672430
Hungary	T43493
Ireland	58533	Nasal compositions containing vitamin B
Australia	584703
Japan	H0669952

NASCOBAL Market Analysis and Financial Projection Experimental

Vitamin B12 Market Dynamics and Financial Trajectory: A Deep Dive into NASCOBAL and Related Segments

Introduction to Vitamin B12 and NASCOBAL

Vitamin B12, a crucial nutrient for the human body, is essential for the production of red blood cells, nerve function, and DNA synthesis. NASCOBAL, a brand of vitamin B12, is part of a broader market that is experiencing significant growth driven by various factors.

Global Vitamin B12 Market Size and Growth

The global vitamin B12 market is projected to grow substantially over the next decade. By 2032, the market size is expected to reach $346.6 million, up from $205.0 million in 2024, with a Compound Annual Growth Rate (CAGR) of 6.8% during the forecast period[1][4].

Market Segmentation by Type

The vitamin B12 market is segmented into several types, including cyanocobalamin, hydroxocobalamin, methylcobalamin, adenosylcobalamin, and others.

Cyanocobalamin

Cyanocobalamin dominates the market with the largest revenue share due to its stability, affordability, and widespread availability. It is commonly prescribed by doctors and available in pharmacies, supermarkets, and health food shops[4].

Methylcobalamin

Methylcobalamin holds the second-largest market share, driven by its superior bioavailability, enhanced neurological benefits, and suitability for individuals with genetic mutations. Its pharmacological activities and neurological benefits are key advantages[1].

Adenosylcobalamin

Adenosylcobalamin also holds considerable revenue due to its increased accessibility and wide availability, coupled with advancements in production technologies. This segment is expected to grow as more people opt for these supplements[1].

Market Segmentation by Application

The market is segmented into pharmaceutical grade, food grade, and feed grade applications.

Pharmaceutical Grade

The pharmaceutical grade segment is anticipated to grow significantly, driven by the safety and purity of these products. The rising prevalence of conditions such as peripheral neuropathy, macular degeneration, and atrophic gastritis is expected to fuel the use of cobalamin as adjuvant therapy[1][4].

Food Grade

The food grade segment dominated the market in 2023, driven by the growing health awareness and increasing consumption of fortified foods. The aging population, age-related complications, and the shift toward vegan diets are key factors contributing to this growth[1].

Feed Grade

While less prominent, the feed grade segment also plays a role, particularly in animal nutrition, where vitamin B12 is essential for the health and growth of livestock.

Market Segmentation by End-User

The market is categorized into the pharmaceutical industry, food & nutraceuticals industry, and others.

Pharmaceutical Industry

The pharmaceutical industry is a significant end-user, with a growing demand for vitamin B12 supplements due to neurological conditions and pernicious anemia. This segment is expected to grow considerably during the forecast period[1][4].

Food & Nutraceuticals Industry

The food & nutraceuticals industry dominated the market in 2023, driven by the growing demand for nutrition products. The increasing usage of cobalamin as a fortifying agent in products like dairy, meat substitutes, and energy drinks is a key factor[1].

Regional Market Dynamics

North America

North America holds the largest market share, driven by the high prevalence of vitamin B12 deficiency, advanced healthcare sector, and the availability of a wide range of products. The region's robust healthcare infrastructure and focus on preventative care also contribute to its dominance[1][4].

Europe

Europe is expected to grow the fastest during the forecast period, driven by an increasing inclination towards preventative healthcare measures and a rising prevalence of chronic diseases. The region's development in research and innovation in healthcare and nutrition also supports this growth[1][4].

Asia Pacific

The Asia Pacific region is also experiencing significant growth, attributed to increasing awareness, rising prevalence of Neglected Tropical Diseases (NTDs), and micronutrient malnourishment. The region's large population and growing healthcare needs are additional drivers[1].

Competitive Landscape

The vitamin B12 market is competitive, with several major players including EUROAPI, CSPC Pharmaceutical Group Co., Ltd., and Ningxia Kingvit Pharmaceutical. Hebei Yuxing is notable for its robust production capacity, which has helped it dominate the market[1].

Financial Trajectory

The financial trajectory of the vitamin B12 market is positive, with a projected CAGR of 6.8% from 2024 to 2032. The market's growth is supported by increasing healthcare provisions, consumer demand for both imported and domestic pharmaceutical products, and the expanding use of vitamin B12 in various industries[1][4].

Key Drivers of Market Growth

• Increasing Health Awareness: Growing health awareness and the rising demand for health supplements are significant drivers.
• Preventative Healthcare: The shift towards preventative healthcare measures, especially in regions like Europe, is boosting the market.
• Vegan Diet Trends: The increasing adoption of vegan diets is driving the demand for vitamin B12 supplements and fortified foods.
• Technological Advancements: Advancements in production technologies are enhancing the availability and quality of vitamin B12 supplements.
• Chronic Diseases: The rising prevalence of chronic diseases and conditions such as peripheral neuropathy and pernicious anemia is fueling the demand for pharmaceutical-grade vitamin B12[1][4].

Challenges and Opportunities

Challenges

• Regulatory Hurdles: Strict regulatory environments can pose challenges for new entrants and product approvals.
• Competition: The market is highly competitive, which can make it challenging for new players to gain significant market share.

Opportunities

• Emerging Markets: Regions like the Asia Pacific offer significant growth opportunities due to increasing awareness and healthcare needs.
• Innovative Products: The development of bio-available supplements and fortified foods presents opportunities for market expansion.
• Research and Development: Continuous research and innovation in healthcare and nutrition can lead to new applications and growth avenues[1][4].

Key Takeaways

• The global vitamin B12 market is expected to grow significantly, driven by health awareness, preventative healthcare, and technological advancements.
• North America dominates the market, but Europe and the Asia Pacific are expected to show rapid growth.
• The pharmaceutical and food & nutraceuticals industries are key end-users, with the pharmaceutical segment witnessing significant CAGR growth.
• Major players like EUROAPI and CSPC Pharmaceutical Group Co., Ltd. are driving the market forward.

FAQs

What is the projected market size of the global vitamin B12 market by 2032?

The global vitamin B12 market is projected to reach $346.6 million by 2032[1].

Which segment dominates the vitamin B12 market by type?

The cyanocobalamin segment dominates the market with the largest revenue share due to its stability and affordability[4].

What are the key drivers of the vitamin B12 market growth?

Key drivers include increasing health awareness, preventative healthcare measures, vegan diet trends, technological advancements, and the rising prevalence of chronic diseases[1][4].

Which region holds the largest market share in the vitamin B12 market?

North America holds the largest market share, driven by the high prevalence of vitamin B12 deficiency and advanced healthcare infrastructure[1][4].

What are the major applications of vitamin B12 in the market?

The major applications include pharmaceutical grade, food grade, and feed grade, with the pharmaceutical and food grade segments being the most significant[1].

Sources

1. Fortune Business Insights: Vitamin B12 Market Size, Share, Growth | Industry Report [2032][1]
2. Lupin Annual Report 2018: lupin-annual-report-2018.pdf[2]
3. Roots Analysis: Nasal Drug Delivery Market Size, Growth & Analysis 2035[3]
4. GlobeNewswire: Global Vitamin B12 Market Size To Exceed USD 0.59 Billion By 2033[4]