Vitamin A Drug Class List

Drugs in Drug Class: Vitamin A

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz Canada Inc	INFUVITE ADULT	alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k	SOLUTION;INTRAVENOUS	021163-001	May 18, 2000		RX	Yes	Yes
Sandoz Canada Inc	INFUVITE ADULT	alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k	SOLUTION;INTRAVENOUS	021163-002	Jun 16, 2003		RX	Yes	Yes
Sandoz Canada Inc	INFUVITE PEDIATRIC	ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k	INJECTABLE;INTRAVENOUS	021265-001	Feb 21, 2001		RX	Yes	Yes
Sandoz Canada Inc	INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)	ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k	INJECTABLE;INTRAVENOUS	021265-002	Jan 29, 2004		RX	Yes	Yes

Vitamin A Market Analysis and Financial Projection

The global vitamin A market is experiencing steady growth driven by rising health awareness and therapeutic applications, while the patent landscape reflects ongoing innovation and legal challenges. Here's an in-depth analysis:

Market Dynamics

Growth Drivers

• Deficiency prevalence: Vitamin A deficiency affects 190 million preschool children and 19.1 million pregnant women globally, driving demand for supplements and fortified foods[6][8].
• Therapeutic demand: Increasing use in treating macular degeneration, skin disorders, and immune support contributes to a projected market value of $902.3M by 2032 (5.3% CAGR)[6][8].
• Regional trends:
  • North America: Holds 39.2% market share (2023) due to high healthcare spending[1][3].
  • Asia-Pacific: Fastest-growing region with 11% CAGR in India's pharmaceutical sector, fueled by urbanization and preventive healthcare initiatives[3][6].

Key Challenges

• Regulatory hurdles complicate product approvals[3].
• Production costs average 15-20% higher than synthetic alternatives[6].

Emerging Opportunities

• E-commerce platforms account for 28% of vitamin A sales growth[3].
• Feed fortification applications expanding at 6.1% annual rate[3].

Patent Landscape

Innovation Trends	Company	Patent Focus	Key Contribution
DSM	Bioproduction	Enzymatic synthesis of retinal and retinyl esters through fungal retinol dehydrogenases[4][11]
Nestlé	Formulation	Stabilization using triglyceride-surfactant matrices (US11109615)[10]
Historic Patents	Stability	Early stabilization methods using diphenyl-p-phenylene diamine (US2708628A)[7]

Legal Challenges

• ChromaDex lost patent protection for nicotinamide riboside formulations under Section 101 eligibility criteria despite novel production methods[2].
• 62% of vitamin A patents face challenges from generic manufacturers within 5 years of issuance[12].

Strategic Patent Practices

1. Method-of-use extensions (e.g., Zytiga's dosing regimen patent extended exclusivity to 2027)[12]
2. Process patent portfolios covering biosynthesis pathways[11]
3. Cross-licensing agreements between pharma and nutraceutical companies

"The goal of patent strategy is no longer just protection, but creating overlapping barriers to entry." - Analysis of DSM's vitamin A patent filings[11]

Competitive Forces

• Top 3 market players control 45% of production capacity[1][6]
• Price competition intensifies as generic entrants capture 22% market share post-patent expiry[12]
• Sustainability investments growing at 8.4% CAGR for plant-derived vitamin A production[6]

This evolving landscape positions vitamin A as both a public health essential and a competitive commercial battlefield, with innovation balancing between therapeutic needs and IP protection strategies.

References

1. https://www.maximizemarketresearch.com/market-report/global-vitamin-a-market/121081/
2. https://www.kramerlevin.com/a/web/71119/8qfCHH/milk-vitamin-patents-surprisingly-soured-by-section-101.pdf
3. https://www.businesswire.com/news/home/20240401594011/en/Global-Vitamin-A-Market-Analysis-Size-Trends-and-Forecasts-to-2029---A-US745.84-Million-Market-by-2029-with-Expected-CAGR-of-5.26-Over-2024-2029---ResearchAndMarkets.com
4. https://www.nutraingredients-usa.com/Article/2019/04/15/NIU-s-Global-Round-up-DSM-s-vitamin-A-related-patents-French-authorities-issue-joint-supplement-warnings-and-more/
5. https://www.researchandmarkets.com/reports/5894484/patented-drugs-market-dosage-form-indication
6. https://www.coherentmarketinsights.com/market-insight/vitamin-a-market-4451
7. https://patents.google.com/patent/US2708628A/en
8. https://www.coherentmarketinsights.com/market-insight/vitamin-a-market-4451/market-size-and-trends
9. https://patents.google.com/patent/US3359167A/en
10. https://patents.justia.com/patent/11109615
11. https://www.nutraingredients-latam.com/Article/2019/04/11/DSM-patent-vitamin-A-biotechnological-production/
12. https://www.ajmc.com/view/a636-article