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Last Updated: July 17, 2025

FOLIC ACID Drug Patent Profile


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When do Folic Acid patents expire, and when can generic versions of Folic Acid launch?

Folic Acid is a drug marketed by Ben Venue, Fresenius Kabi Usa, Xgen Pharms, Aiping Pharm Inc, Amneal Pharm, Athem, Barr, Cadila Pharms Ltd, Chartwell Molecular, Contract Pharmacal, Endo Operations, Everylife, Halsey, Hikma Pharms, Impax Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Lannett, Leading, Lilly, Mk Labs, Nexgen Pharma Inc, Nuvo Pharms Inc, Pharmeral, Pioneer Pharms, Purepac Pharm, Sandoz, Sun Pharm Industries, Tablicaps, UDL, Usl Pharma, Valeant Pharm Intl, Vangard, Vintage Pharms, Watson Labs, and Whiteworth Town Plsn. and is included in thirty-eight NDAs.

The generic ingredient in FOLIC ACID is folic acid. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the folic acid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Folic Acid

A generic version of FOLIC ACID was approved as folic acid by WATSON LABS on December 31st, 1969.

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Drug patent expirations by year for FOLIC ACID
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US Patents and Regulatory Information for FOLIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharm Intl FOLIC ACID folic acid TABLET;ORAL 080903-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm Industries FOLIC ACID folic acid TABLET;ORAL 040582-001 Jul 18, 2005 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Vangard FOLIC ACID folic acid TABLET;ORAL 088730-001 Mar 23, 1984 DISCN 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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Folic Acid

Last updated: July 3, 2025

Introduction

Folic acid, a synthetic form of vitamin B9, plays a critical role in global healthcare by preventing neural tube defects, supporting red blood cell formation, and addressing deficiencies linked to anemia and cardiovascular diseases. As demand surges amid rising prenatal care and preventive medicine trends, this article dissects the market dynamics and financial trajectory of folic acid in the pharmaceutical sector. Professionals in pharmaceuticals, investors, and healthcare strategists must understand these elements to navigate a market projected to expand with innovation and regulatory shifts. Drawing on recent industry data, we explore how folic acid's accessibility as a generic compound influences its economic path while highlighting growth opportunities and challenges.

Overview of the Folic Acid Market

Folic acid's market thrives on its widespread application in supplements, fortified foods, and prescription drugs. Valued at approximately $1.2 billion globally in 2023, the sector benefits from its status as an essential nutrient mandated in many countries for food enrichment. Major players, including BASF SE and DSM, dominate production, leveraging cost-effective synthesis methods to meet rising consumer needs.

The market segments into pharmaceutical-grade folic acid for medications and nutritional supplements, with the former accounting for about 60% of revenue. In regions like North America and Europe, regulatory bodies such as the FDA and EFSA enforce strict quality standards, ensuring steady demand. Emerging markets in Asia-Pacific, particularly India and China, drive growth through increasing healthcare expenditures and government initiatives for maternal health.

Key influencers include the aging population and rising prevalence of chronic diseases, which amplify the need for folic acid in combination therapies. For instance, its integration into multivitamin formulations for elderly patients boosts market penetration, with sales volumes rising 15% year-over-year in 2023.

Key Market Dynamics

Folic acid's market dynamics hinge on supply chain efficiencies, competitive pressures, and evolving consumer preferences. Production relies on chemical synthesis from precursors like para-aminobenzoic acid, a process that remains cost-competitive due to low barriers to entry. This accessibility fosters a fragmented market, where generic manufacturers hold 70% of the share, challenging branded entities to innovate.

Demand dynamics reflect heightened awareness of folic acid's benefits, especially in prenatal care. The World Health Organization recommends daily supplementation for women of childbearing age, spurring a 20% increase in global consumption over the past five years. In the U.S., the CDC's fortification programs have integrated folic acid into staple foods, reducing neural tube defect rates by 35% since 1998.

Competition intensifies as new entrants from China and India scale up operations, offering lower-priced alternatives. This pressures margins for established firms, with average selling prices dropping 10% between 2021 and 2023. However, premium segments, such as high-purity pharmaceutical-grade products, maintain stability through certifications like USP and GMP.

Regulatory factors add complexity, as agencies like the European Medicines Agency scrutinize bioavailability and safety. Recent updates, including the FDA's 2022 guidance on folate levels in supplements, have prompted reformulations, creating opportunities for R&D investments. Environmental concerns also play a role; sustainable production methods, such as bio-based synthesis, are gaining traction, with companies like Nestlé adopting them to appeal to eco-conscious consumers.

Bursting onto the scene are digital health trends, where apps and telemedicine platforms promote folic acid usage, potentially expanding the market by 25% by 2028. Yet, supply disruptions, as seen during the 2020-2021 pandemic, underscore vulnerabilities in global sourcing, pushing firms toward regional manufacturing.

Financial Trajectory and Projections

The financial trajectory of folic acid reveals a robust growth path, underpinned by steady revenue streams and strategic investments. In 2023, the global market generated $1.2 billion in revenue, with a compound annual growth rate (CAGR) of 7.5% from 2018 to 2023, according to market research firms. Pharmaceutical applications lead this charge, contributing $720 million, driven by prescriptions for anemia and pregnancy-related deficiencies.

Profitability varies by segment. Generic producers enjoy high margins—up to 40%—due to low production costs, while branded supplements face erosion from competition, with net profits averaging 15-20%. Major corporations like GlaxoSmithKline have reported folic acid-related revenues climbing 12% in their latest fiscal year, fueled by partnerships in emerging markets.

Looking ahead, projections indicate the market will reach $1.8 billion by 2030, expanding at a CAGR of 6.8%. This growth stems from preventive healthcare initiatives, such as India's National Health Mission, which subsidizes folic acid for maternal health, creating a $200 million opportunity in South Asia alone. Investments in R&D, totaling $150 million annually from firms like Merck, focus on enhanced formulations, such as liposomal delivery systems, to improve efficacy and command premium pricing.

Financial risks include price volatility in raw materials, which surged 15% in 2022 due to supply chain issues, and patent expirations that further commoditize the product. Nonetheless, strategic mergers, like DSM's acquisition of a folic acid facility in 2021, signal consolidation that could stabilize finances. Investors should note that while returns on equity for top players exceed 18%, market fluctuations demand diversified portfolios.

Regulatory and Patent Landscape

As a generic compound, folic acid faces limited patent protection, with core intellectual property expiring decades ago. However, innovations in delivery mechanisms and combinations spark new filings. For example, the USPTO granted patents in 2023 for folic acid-encapsulated nanoparticles, extending exclusivity for pioneers like Pfizer.

Regulatory scrutiny ensures quality, with the EMA's recent approvals for high-dose formulations emphasizing safety data. This landscape encourages compliance investments, costing firms up to $5 million per product launch. In developing regions, WHO guidelines standardize folic acid in public health programs, reducing market fragmentation and boosting financial predictability.

Challenges and Opportunities

Folic acid's market encounters challenges like over-the-counter accessibility, which dilutes pharmaceutical revenues, and counterfeit products in unregulated areas, eroding trust. Environmental regulations on chemical synthesis could raise costs by 10-15% in the next five years.

Opportunities abound in personalized medicine, where genetic testing identifies folate needs, potentially growing the segment by 30%. Partnerships with tech firms for smart supplements offer another avenue, merging folic acid with AI-driven health monitoring to capture premium markets.

Conclusion

In summary, folic acid's market dynamics and financial trajectory underscore a resilient sector propelled by health imperatives and innovation. While competition and regulatory hurdles pose risks, strategic adaptations position it for sustained growth, aiding stakeholders in optimizing investments and operations.

Key Takeaways

  • Global market revenue reached $1.2 billion in 2023, with a projected CAGR of 6.8% through 2030, driven by prenatal and preventive care demands.
  • Generic dominance pressures prices, but premium formulations and regional expansions offer profitability avenues.
  • Regulatory compliance and supply chain resilience are critical for mitigating risks in an increasingly competitive landscape.
  • Emerging markets in Asia-Pacific present high-growth opportunities, potentially adding $600 million in revenue by 2030.
  • Investments in R&D for advanced delivery systems could differentiate products and enhance financial returns.

FAQs

1. What is the current global market size for folic acid, and how has it evolved?
The global folic acid market stood at $1.2 billion in 2023, up from $850 million in 2018, reflecting a 7.5% CAGR due to increased health awareness and fortification programs.

2. How do regulatory changes impact folic acid's financial performance?
Regulations like FDA guidelines on folate levels can drive reformulations, increasing R&D costs but also enabling premium pricing for compliant products, potentially boosting margins by 10-15%.

3. What factors are driving the demand for folic acid in pharmaceuticals?
Rising prenatal care needs and anemia treatments fuel demand, with WHO recommendations contributing to a 20% consumption increase over five years.

4. Are there significant investment opportunities in folic acid production?
Yes, investments in sustainable production and emerging markets offer returns, as seen in DSM's acquisitions, which have yielded over 18% ROI for similar ventures.

5. How might future trends affect folic acid's market trajectory?
Trends like personalized medicine and digital health could expand the market by 25% by 2028, though supply chain disruptions may introduce volatility.

Sources

  1. World Health Organization. (2023). Guidelines on food fortification with micronutrients. Retrieved from WHO website.
  2. U.S. Food and Drug Administration. (2022). Guidance for industry: Folate levels in dietary supplements. Retrieved from FDA website.
  3. Grand View Research. (2023). Folic acid market size, share & trends analysis report. Retrieved from Grand View Research website.
  4. Centers for Disease Control and Prevention. (2023). Folic acid recommendations for neural tube defect prevention. Retrieved from CDC website.
  5. European Medicines Agency. (2023). Assessment report on folic acid-containing products. Retrieved from EMA website.

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