You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 18, 2025

FOLVITE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Folvite, and when can generic versions of Folvite launch?

Folvite is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in FOLVITE 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 Folvite

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

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for FOLVITE?
  • What are the global sales for FOLVITE?
  • What is Average Wholesale Price for FOLVITE?
Summary for FOLVITE
Drug patent expirations by year for FOLVITE
Recent Clinical Trials for FOLVITE

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

SponsorPhase
Korean Cancer Study GroupPhase 3
Asan Medical CenterPhase 3
Jawaharlal Institute of Postgraduate Medical Education & ResearchPhase 3

See all FOLVITE clinical trials

US Patents and Regulatory Information for FOLVITE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms Inc FOLVITE folic acid INJECTABLE;INJECTION 005897-008 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Pharms Inc FOLVITE folic acid TABLET;ORAL 005897-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started 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 FOLVITE

Last updated: July 30, 2025

Introduction

FOLVITE, a well-established B-vitamin supplement primarily composed of folic acid, has historically played a pivotal role in preventive healthcare, especially in prenatal care and anemia management. As a widely prescribed and OTC supplement, its market dynamics are influenced by evolving healthcare policies, demographic shifts, regulatory landscapes, and emerging scientific evidence. This analysis explores the current market environment, growth drivers, competitive positioning, and future financial prospects for FOLVITE.

Market Overview

Global Market Landscape

The global vitamin and supplement market has seen steady growth, driven by rising health awareness, increasing prevalence of nutritional deficiencies, and an aging population. The B-vitamin segment, including folic acid products like FOLVITE, accounts for a significant share of this growth, particularly within prenatal and hematological health sectors [1].

Regional Market Dynamics

  • North America: The U.S. dominates the market due to high healthcare awareness, strong OTC supplement sales, and strict regulatory endorsement of folate's role in pregnancy health. The FDA's recommendations for folic acid intake have further propelled market demand.

  • Europe: Strict regulatory policies and established healthcare protocols have positioned FOLVITE as a key supplement, especially in prenatal care, despite regional variations in supplement usage.

  • Asia-Pacific: Rapid economic growth, increasing health literacy, and government initiatives promoting maternal health have expanded the regional market, with notable demand in China and India.

Market Segments

  • Prescription: Primarily for anemia and neural tube defect prevention.
  • Over-the-Counter (OTC): Widely available for general health maintenance, with increasing consumer-driven demand.
  • Fortified Foods: Incorporation of folic acid into staple foods, influencing demand indirectly.

Key Market Drivers

Demographic Trends

  • Prenatal Care Demand: The rise in pregnancies and infertility treatments has amplified the need for folate supplementation.
  • Aging Population: Age-related deficiencies in B-vitamins foster sustained demand, especially among elderly populations at risk for cognitive decline and cardiovascular issues.

Scientific and Medical Evidence

  • Prevention of Neural Tube Defects: Extensive clinical data underscores folic acid's efficacy in preventing congenital anomalies, cementing its role in standard prenatal protocols [2].
  • Link to Cardiovascular Health: Emerging research suggests benefits in homocysteine reduction, driving broader preventive applications [3].

Regulatory and Policy Support

  • Mandatory Food Fortification: Several countries have mandated folic acid fortification in grains, indirectly boosting demand for supplements like FOLVITE.
  • Healthcare Guidelines: Endorsements from health authorities, including CDC and WHO, continue to reinforce the supplement’s importance.

Market Challenges

  • Regulatory Constraints: Variability in policies across regions can limit marketing and distribution.
  • Market Saturation: Several generic equivalents and competing brands influence pricing strategies and profit margins.
  • Public Awareness: Despite strong evidence, misconceptions about supplementation may impact consumer behavior.

Competitive Landscape

FOLVITE operates within a crowded market of generic and branded folic acid products. Major players include Johnson & Johnson, Pfizer, and local pharmaceutical companies. Differentiation hinges on formulation, dosage, brand trust, and distribution channels.

Positioned as a trusted brand with proven efficacy, FOLVITE benefits from brand recognition and prescriber endorsement, though its market share faces pressure from generics and private labels.

Financial Trajectory Analysis

Revenue Generation and Growth Trends

FOLVITE’s revenue trajectories are closely aligned with the growth of prenatal and general health supplement segments. In mature markets, sales volume growth may plateau, but price stability and incremental penetration into new regional markets provide avenues for sustained revenues.

Market Penetration Strategies

  • Expanding Indications: Leveraging emerging scientific evidence to endorse additional uses, such as cognitive health.
  • Geographic Expansion: Targeted marketing in emerging markets post-regulatory approval.
  • Product Line Extensions: Developing formulations with added nutrients or formulations catering to specific demographics.

Profitability Outlook

Profit margins for folic acid products are generally high owing to low manufacturing costs and high demand. However, intense competition and regulatory actions may pressure pricing, necessitating innovation and strategic marketing to maintain margins.

Investment and R&D Considerations

Ongoing clinical research adds value to FOLVITE’s market position. Investment in clinical trials, bioequivalence studies, and novel delivery mechanisms (e.g., sustained-release formulations) can bolster market share and open new revenue streams.

Short to Mid-Term Outlook

Given current demographic and regulatory trends, FOLVITE is poised for moderate growth over the next 3 to 5 years. Market saturation in developed regions may temper growth, but expansion into emerging markets and endorsements for broader health benefits provide growth catalysts.

Long-Term Forecast

In the long run, the trajectory depends heavily on scientific advancements, regulatory changes, and competitive responses. Potential breakthroughs in personalized nutrition and digital health integration could reshape market strategies, propelling FOLVITE further.

Future Market Opportunities

  • Personalized Supplementation: Tailoring folic acid dosages based on genetic testing to optimize efficacy.
  • Digital Health Integration: Utilizing apps and telemedicine platforms to increase consumer engagement and adherence.
  • Synergistic Formulations: Combining folic acid with other essential nutrients, such as vitamin B12 or iron, for comprehensive nutritional support.

Regulatory and Ethical Considerations

Compliance with international standards (FDA, EMA, etc.) remains paramount. Transparency regarding manufacturing processes, sourcing, and clinical evidence enhances consumer trust and mitigates regulatory risks.

Risks and Mitigation Strategies

  • Regulatory Changes: Active monitoring and early adaptation to policy updates.
  • Market Competition: Continual innovation and robust marketing to preserve brand loyalty.
  • Scientific Disputes: Investing in credible research to substantiate health claims.

Key Takeaways

  • FOLVITE enjoys a stable demand baseline driven by prenatal health needs and demographic shifts.
  • Expansion into emerging markets and broader health indications represent significant growth avenues.
  • Competitive differentiation, R&D investment, and regulatory compliance are critical to sustaining profitability.
  • Advancements in personalized nutrition and digital health integration will shape future market trajectories.
  • Strategic positioning as a trusted and innovative brand will underpin long-term financial performance.

FAQs

1. What is the primary medical indication for FOLVITE?
FOLVITE is mainly indicated for the prevention of neural tube defects during pregnancy and treatment of folic acid deficiency anemia.

2. How does regulatory variability affect FOLVITE's global market?
Differences in food fortification policies, prescription requirements, and labeling standards across countries influence manufacturing, marketing, and sales strategies, potentially creating barriers or opportunities in various regions.

3. Can FOLVITE be used for non-pregnancy-related health benefits?
Yes. Emerging evidence suggests benefits in cardiovascular health and cognitive function, prompting some broad-spectrum use, although official indications primarily focus on pregnancy and anemia.

4. What are the main competitive challenges faced by FOLVITE?
Market saturation with generic options, price competition, and the need for ongoing scientific validation to differentiate the brand.

5. What future innovations could influence FOLVITE’s market position?
Advancements in personalized supplementation, combination formulations, and integrating digital health tools can enhance consumer engagement and efficacy perceptions.


References

[1] MarketsandMarkets, "Vitamins Market by Type and Geography," 2022.
[2] World Health Organization, "Prevention of neural tube defects," 2019.
[3] Johnson, E. et al., "Folic acid and cardiovascular health," Journal of Nutritional Science, 2021.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.