CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE - Generic Drug Details

What are the generic sources for citric acid; lactic acid; potassium bitartrate and what is the scope of patent protection?

Citric acid; lactic acid; potassium bitartrate is the generic ingredient in one branded drug marketed by Evofem Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Citric acid; lactic acid; potassium bitartrate has forty-six patent family members in eighteen countries.

One supplier is listed for this compound.

Summary for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

International Patents:	46
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
DailyMed Link:	CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

Constraining patent/regulatory exclusivity:

11,337,989

Dosage:

GEL;VAGINAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

Drug Class	Anti-coagulant Calculi Dissolution Agent
Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

Anatomical Therapeutic Chemical (ATC) Classes for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

A09AB	Acid preparations
A09A	DIGESTIVES, INCL. ENZYMES
A09	DIGESTIVES, INCL. ENZYMES
A	Alimentary tract and metabolism

G01AD	Organic acids
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PHEXXI	Vaginal Gel	citric acid; lactic acid; potassium bitartrate	1.8%/1%/0.4%	208352	1	2023-02-28

US Patents and Regulatory Information for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	11,992,472
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	10,568,855
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	11,337,989
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	11,439,610		Y	Y

Expired US Patents for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020	6,706,276

International Patents for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

Country	Patent Number	Title	Estimated Expiration
Mexico	2021001742
Mexico	365905	COMPOSICIONES Y MÉTODOS PARA MEJORAR LA EFICACIA DE MICROBICIDAS ANTICONCEPTIVOS. (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES.)
Japan	2020125298
World Intellectual Property Organization (WIPO)	2015095793
South Africa	201500111	COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES
South Korea	102407408

Market Dynamics and Financial Trajectory for Citric Acid, Lactic Acid, and Potassium Bitartrate in the Pharmaceutical Sector

Last updated: July 31, 2025

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Introduction

The pharmaceutical industry continually evolves under the influence of technological advancements, regulatory shifts, and fluctuating market demands. Among the myriad of chemical compounds utilized, citric acid, lactic acid, and potassium bitartrate stand out due to their multifaceted applications in pharmaceutical formulations, excipients, and nutraceuticals. This report analyzes the current market dynamics and projects the financial trajectory for these compounds, providing insights essential for industry stakeholders seeking strategic positioning.

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Market Overview

Citric Acid

Citric acid is a naturally occurring organic acid extensively used as a pH adjuster, preservative, and flavoring agent in pharmaceuticals and nutraceuticals. Its widespread use in effervescent tablets, biopharmaceuticals, and injectable formulations underscores its critical role.

The global citric acid market, valued at approximately USD 3.0 billion in 2022, is driven by the surge in demand for organic and natural excipients, rising healthcare expenditure, and innovations in drug delivery systems (MarketWatch, 2023)[1].

Lactic Acid

Lactic acid functions as a pH regulator, antimicrobial agent, and chiral building block. Its application extends to biodegradable polymers, topical formulations, and oral solutions.

The lactic acid market is valued at around USD 2.4 billion globally, with pharmaceutical applications accounting for a significant share. Growth is propelled by the expanding biopharmaceutical sector and rising preference for eco-friendly manufacturing processes (Grand View Research, 2023)[2].

Potassium Bitartrate

Commonly known as cream of tartar, potassium bitartrate is primarily used as an excipient and stabilizer in tablet manufacturing, as well as in the production of effervescent formulations. Although its pharmaceutical use is niche compared to citric and lactic acids, demand persists owing to its stabilizing properties and safety profile.

The market size for potassium bitartrate remains relatively modest at USD 150 million, with incremental growth projected owing to increased research into innovative excipient applications (Research and Markets, 2023)[3].

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Market Dynamics

Supply Chain and Raw Material Accessibility

The raw materials for these compounds are primarily derived from natural sources or through fermentation processes, aligning with the clean-label trend. Citric acid is predominantly produced via fermentation of sugar substrates using Aspergillus niger, offering scalability and sustainability benefits. Lactic acid is similarly produced through bacterial fermentation, with overcapacity in Asia fueling availability.

Environmental regulations promoting green manufacturing practices influence supply chains, with a shift toward bio-based production facilities in North America and Europe. These factors impact raw material cost stability and suppliers’ geopolitical risk.

Regulatory Landscape

Stringent regulatory frameworks governing pharmaceutical excipients necessitate rigorous safety evaluations and compliance with pharmacopeial standards such as USP, EP, and JP. The increasing emphasis on excipient transparency and Good Manufacturing Practices (GMP) influences manufacturing costs and approval timelines.

Recent initiatives encourage the use of natural, non-toxic excipients, benefiting citric and lactic acids, which have established safety profiles. Conversely, potassium bitartrate’s niche position subjects it to less regulatory scrutiny but constrains its growth potential.

Technological Innovations

Advancements in fermentation technologies, purification processes, and scalable manufacturing bolster supply capabilities and reduce costs. The development of novel drug delivery systems, such as liposomes and controlled-release formulations, further enhances the utility of these acids.

Additionally, the integration of these acids in bioconjugation and stabilization strategies opens avenues for innovative applications, increasing their pharmaceutical relevance.

Market Drivers

• Growing demand for natural excipients: Consumers and regulators favor bio-based, non-toxic excipients, bolstering the use of citric and lactic acids.
• Expansion of biopharmaceuticals: Both acids serve as pH regulators and stabilizers, essential in antibody formulations, vaccines, and gene therapies.
• Innovation in drug delivery systems: Effervescent and controlled-release formulations rely heavily on citric acid and potassium bitartrate.
• Regulatory pressures: Enhanced safety and quality standards drive adoption of well-characterized acids.

Market Challenges

• Price volatility: Fluctuations in raw material costs, especially in regions with supply chain susceptibilities.
• Regulatory hurdles: Extended approval processes and need for extensive documentation can delay product launch.
• Market saturation: Mature markets with established suppliers limit growth opportunities in certain regions.

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Financial Trajectory and Forecast

Short to Mid-Term Outlook (2023–2028)

The compounded annual growth rate (CAGR) for citric acid and lactic acid in pharmaceutical applications is projected at approximately 5–7%, driven by increased demand for clean-label excipients and biologics (MarketsandMarkets, 2023)[4]. Potassium bitartrate's growth, constrained by its niche application, is estimated at 2–3% CAGR.

Factors influencing these trajectories include:

• Expansion of biosimilars and biologics: The need for pH buffers in formulations sustains demand.
• Shift toward plant-based and sustainable manufacturing: Favorable for bio-fermentation processes, encouraging industry investments.
• Emerging markets: India, China, and Latin America are expected to see accelerated consumption growth owing to expanding pharmaceutical manufacturing capacities.

Revenue Projections

Compound	2023 (USD Billion)	2028 (USD Billion)	CAGR (%)	Key Drivers
Citric Acid	3.0	4.5	7%	Biopharmaceutical expansion, natural trend
Lactic Acid	2.4	3.5	6.5%	Biodegradable polymers, topical use
Potassium Bitartrate	0.15	0.20	3%	Niche applications, innovation potential

Investment and Profitability Outlook

Manufacturers investing in bio-fermentation facilities and R&D for novel excipients are positioned to capitalize on the steady growth. Cost efficiencies via process optimization and scale-up are anticipated to enhance profit margins. Premium formulations requiring high-purity grades command higher pricing, positively impacting revenues.

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Strategic Implications for Industry Stakeholders

• Diversification: Companies should diversify sourcing and manufacturing bases to mitigate geopolitical and supply chain risks.
• Innovation: Investment in novel applications, such as targeted drug delivery systems, can unlock premium markets.
• Regulatory alignment: Maintaining compliance with evolving standards accelerates approval and market access.
• Sustainability: Emphasizing bio-based and eco-friendly production aligns with market trends and consumer preferences.

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Key Takeaways

• The pharmaceutical application of citric acid and lactic acid is poised for sustained growth driven by innovation, regulatory support, and increasing demand for natural excipients.
• Potassium bitartrate maintains a niche but stable market, with incremental growth opportunities arising from research into new excipient functions.
• Supply chain resilience hinges on bio-fermentation technology advancements and geographic diversification.
• Industry players should prioritize R&D to develop value-added formulations, optimize manufacturing processes, and adhere to stringent safety standards.
• Strategic investments in sustainable production methods will bolster competitiveness amid tightening environmental regulations and market preferences.

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FAQs

1. What factors primarily influence the price of citric acid in the pharmaceutical industry?
   Raw material costs, production scale, regulatory compliance expenses, and supply chain stability significantly impact citric acid pricing, with bio-fermentation process efficiencies playing a key role.

2. How does the growth of biological pharmaceuticals impact the demand for these acids?
   The expansion of biologics increases demand for pH regulators and stabilizers like citric and lactic acids, which are integral to formulation stability and biocompatibility.

3. Are there emerging applications for potassium bitartrate in pharmaceuticals?
   Yes, ongoing research explores its use as a stabilizer in innovative, controlled-release, and effervescent drug formulations, suggesting potential for growth despite a niche position.

4. What manufacturing trends are shaping the future of these compounds?
   The shift toward sustainable, plant-based, and bio-fermentation manufacturing methods enhances scalability, cost-effectiveness, and environmental compliance.

5. Which regions are expected to lead in the market growth for these acids?
   Asia-Pacific, particularly China and India, will likely lead due to expanding pharmaceutical manufacturing capacity and investments in bio-production facilities.

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References

1. MarketWatch. (2023). Global Citric Acid Market Size, Share & Trends.
2. Grand View Research. (2023). Lactic Acid Market Analysis.
3. Research and Markets. (2023). Potassium Bitartrate Industry Overview.
4. MarketsandMarkets. (2023). Excipients Market in Pharmaceuticals.

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This comprehensive review equips pharmaceutical industry stakeholders with a strategic understanding of market forces and financial outlooks for citric acid, lactic acid, and potassium bitartrate, facilitating informed decision-making amid dynamic market conditions.