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Last Updated: April 25, 2025

Drugs in MeSH Category Vitamins


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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Long Grove Pharms CALCITRIOL calcitriol INJECTABLE;INJECTION 078066-002 Jan 29, 2008 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Strides Softgels CALCITRIOL calcitriol CAPSULE;ORAL 091356-001 Dec 12, 2014 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Amneal Pharms CALCITRIOL calcitriol CAPSULE;ORAL 203289-002 Jun 14, 2017 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Vitamins Market Analysis and Financial Projection

The global vitamins market has experienced robust growth, driven by increasing health consciousness and fortified by innovations in product formulations. This growth is paralleled by a complex patent landscape that balances intellectual property protection with accessibility challenges.

Market Dynamics of Vitamin Supplements and Fortified Products

The global vitamin supplements market was valued at $47.9 billion in 2021 and is projected to reach $98.6 billion by 2031, growing at a 7.6% CAGR[8]. Broader vitamin applications (including fortified foods and beverages) are expected to expand from $6.7 billion in 2023 to $8.9 billion by 2028 at a 6.0% CAGR[4]. Key drivers include:

  • Post-pandemic demand: Sales surged during COVID-19, with multivitamin use rising by 59% and immune-supporting vitamins (C, D) by 44% and 37%, respectively, among younger demographics[1].
  • Regional growth: North America leads due to preventive healthcare trends, while Asia-Pacific shows the fastest growth, driven by rising middle-class populations[11][14].
  • Product innovation: Gummies, liquid supplements, and plant-based formulations cater to diverse consumer preferences[11].

Regulatory and Quality Challenges

Despite growth, 34% of dietary supplements face issues like adulteration or mislabeling, prompting calls for stricter global quality standards[1]. The MeSH classification for vitamins (e.g., D014807 for Vitamin D[9]) and dietary supplements (D019587[12]) aids in standardizing research and regulatory efforts.


Patent Landscape and Innovation Trends

Vitamin-related patents face unique challenges under U.S. patent law (§101), particularly for formulations combining natural ingredients.

Key Patent Strategies

  • Novel formulations: Successful patents specify precise dosages and applications. For example, a method patent for stabilizing macular degeneration includes ranges like 420–600 mg vitamin C and 400–540 IU vitamin E[2].
  • Avoiding eligibility pitfalls: Courts have invalidated patents claiming natural processes, such as regulating hydronium ions via beta-alanine[2], or formulations of nicotinamide riboside (a milk-derived vitamin)[15].

Notable Cases

  • Ocuvite vs. generics: Bausch + Lomb’s macular degeneration formula survived challenges by narrowly defining therapeutic applications[2].
  • ChromaDex v. Elysium: A Delaware court invalidated patents on a milk-based anti-aging supplement despite novel formulation claims[15].

Global Diffusion Through Patent Pools

The Medicines Patent Pool (MPP) has increased generic drug access in developing countries by 33%, with follow-on trials for vitamin cocktails rising by 18%[5]. However, royalty structures and geographic licensing restrictions complicate market entry for patented vitamin blends.


Future Outlook and Strategic Considerations

  • Natural/organic demand: Plant-based and clean-label products drive 25% of new launches[11].
  • Patent viability: Only 12% of herbal formulations meet non-obviousness standards, emphasizing the need for R&D in synergistic ingredient combinations[7].
  • Emerging markets: Africa and the Middle East show untapped potential, with 63.4% of Algerians increasing supplement use post-pandemic[1].

"The test for inventiveness hinges on whether a formulation delivers a technical effect previously unrealized." – Intellectual Property Analysis[7].

Companies must navigate regulatory rigor while leveraging MeSH taxonomy[6][13] to align research with global standards. As the market approaches $300 billion by 2028[1], strategic patenting and quality control will define competitive advantage.

References

  1. https://pmc.ncbi.nlm.nih.gov/articles/PMC10421343/
  2. https://ipwatchdog.com/2018/09/24/ipatent-protection-pharmaceuticals-dietary-supplements/id=101364/
  3. https://www.newhope.com/regulatory/the-possibilities-for-patenting-supplement-formulations
  4. https://www.marketsandmarkets.com/Market-Reports/vitamins-market-159097794.html
  5. https://www.canadiancentreforhealtheconomics.ca/wp-content/uploads/2022/11/Wang-2022.pdf
  6. https://www.nitrd.gov/nitrdgroups/images/a/ad/ElsevierResponseNLM.pdf
  7. https://priority-ip.co.uk/can-you-protect-herbal-food-supplements-as-products-or-formulations-under-the-current-ip-legal-provisions-to-make-any-investment-in-research-development-worthwhile/
  8. https://www.alliedmarketresearch.com/vitamin-supplements-market-A16898
  9. https://www.ncbi.nlm.nih.gov/mesh?Cmd=DetailsSearch&Term=%22Vitamin+D%22%5BMeSH+Terms%5D
  10. https://patents.justia.com/patents-by-us-classification/514/904
  11. https://www.databridgemarketresearch.com/reports/global-vitamins-market
  12. https://meshb.nlm.nih.gov/record/ui?ui=D019587
  13. https://pmc.ncbi.nlm.nih.gov/articles/PMC6221467/
  14. https://www.grandviewresearch.com/industry-analysis/vitamin-supplements-market-report
  15. https://www.kramerlevin.com/a/web/71119/8qfCHH/milk-vitamin-patents-surprisingly-soured-by-section-101.pdf

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