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 freedom to operate?

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
DailyMed Link:	citric acid; lactic acid; potassium bitartrate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for citric acid; lactic acid; potassium bitartrate

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			Y	Y
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes

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

International Patents for citric acid; lactic acid; potassium bitartrate

Country	Patent Number	Title	Estimated Expiration
South Korea	102062599
Denmark	3082826
Mexico	365905	COMPOSICIONES Y MÉTODOS PARA MEJORAR LA EFICACIA DE MICROBICIDAS ANTICONCEPTIVOS. (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES.)
South Africa	201500111	COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES
Japan	6738573
South Korea	20160103036
Israel	246146

Market Dynamics and Financial Trajectory for the Drug: CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

Introduction

The combination of citric acid, lactic acid, and potassium bitartrate is notably used in the pharmaceutical product Phexxi®, a vaginal gel developed by Evofem Biosciences. This article delves into the market dynamics and financial trajectory of this drug, highlighting key drivers, challenges, and future projections.

Market Overview

Phexxi®, the vaginal gel containing citric acid, lactic acid, and potassium bitartrate, is a non-hormonal, non-systemic contraceptive method. The market for such products is influenced by several factors, including increasing demand for non-hormonal contraceptives, regulatory approvals, and reimbursement strategies.

Key Drivers

Increasing Demand for Non-Hormonal Contraceptives

The demand for non-hormonal contraceptives is on the rise, particularly among women of reproductive age who may be using other medications that could interact with hormonal birth control methods. For instance, the use of GLP-1 agonists like Mounjaro and Zepbound can make oral birth control pills less effective, driving the need for alternative methods like Phexxi[3].

Regulatory Approvals and Reimbursement

Regulatory approvals and favorable reimbursement strategies play a crucial role in the market growth of Phexxi. Recent successes in removing prior authorizations and negotiating rebates with health insurance providers, such as Medi-Cal, have improved the product's accessibility and affordability[3].

Technological and Clinical Advancements

Advances in women's health technologies and clinical trials are essential for the development and approval of new products. Evofem Biosciences' focus on clinical trials and regulatory compliance has been instrumental in the growth of Phexxi[3].

Financial Performance

Revenue Growth

Evofem Biosciences reported $18.2 million in net product sales for Phexxi in 2023, marking a third consecutive year of revenue growth. This increase was driven by more favorable reimbursements and a wholesale acquisition cost (WAC) increase that took effect in October 2022[3].

Cost Reduction and Operational Efficiency

The company has significantly reduced its operating expenses, with a 64% decrease from 2022 levels. This was achieved through reductions in selling and marketing costs, research and development expenses, and general and administrative costs. The sales and marketing expense as a percentage of net sales improved to 54% in the fourth quarter of 2023, the most favorable ratio since the product's launch[3].

Future Financial Projections

Looking ahead, key growth drivers for 2024 include the increasing use of Phexxi among women taking oral contraceptives in conjunction with other medications, a 3% increase in the Phexxi WAC, and ongoing success in executing market access strategies. These factors are expected to continue driving revenue growth and improving the company's financial performance[3].

Market Trends

Personalized Treatment Approaches

The pharmaceutical industry, including the segment for women's health products, is moving towards more personalized treatment approaches. Advances in genomics and biotechnology are enabling tailored treatment plans, which could further enhance the appeal of non-hormonal contraceptives like Phexxi[4].

Digital Health Integration

The integration of digital health technologies, such as mobile apps and telemedicine, is enhancing patient management and adherence. This trend is likely to support the growth of Phexxi by improving patient engagement and access to healthcare services[4].

Regional Market Analysis

North America

North America, particularly the United States, is a significant market for pharmaceutical products, including women's health medications. The region's high per capita healthcare expenditure, extensive healthcare knowledge, and strong GDP contribute to its dominant market share. Phexxi's success in this region is crucial for its overall market performance[1].

Challenges

Competition and Generic Entry

While Phexxi enjoys a unique position in the market, the entry of generic or similar non-hormonal contraceptives could pose a challenge. However, the current lack of direct competitors and the product's unique formulation mitigate this risk to some extent[1].

Regulatory and Reimbursement Challenges

Changes in regulatory environments and reimbursement policies can significantly impact the market dynamics of pharmaceutical products. Continuous efforts to maintain favorable reimbursement strategies are essential for the sustained growth of Phexxi[3].

Key Takeaways

• Growing Demand: Increasing demand for non-hormonal contraceptives driven by interactions with other medications.
• Regulatory and Reimbursement Success: Favorable regulatory approvals and reimbursement strategies enhance product accessibility.
• Financial Efficiency: Significant reduction in operating expenses and improved revenue growth.
• Market Trends: Personalized treatment approaches and digital health integration support market growth.
• Regional Dominance: North America remains a key market due to high healthcare expenditure and strong GDP.

FAQs

What are the key ingredients in Phexxi vaginal gel?

Phexxi vaginal gel contains citric acid, lactic acid, and potassium bitartrate[3].

How has Phexxi's revenue performed in recent years?

Phexxi has seen a third consecutive year of revenue growth, with $18.2 million in net product sales in 2023[3].

What are the main drivers for Phexxi's market growth?

Key drivers include increasing demand for non-hormonal contraceptives, favorable regulatory approvals, and improved reimbursement strategies[3].

How has Evofem Biosciences reduced its operating expenses?

The company reduced its operating expenses by 64% through cuts in selling and marketing costs, research and development expenses, and general and administrative costs[3].

What are the future growth prospects for Phexxi?

Future growth is expected to be driven by increasing use among women taking oral contraceptives with other medications, a WAC increase, and ongoing market access strategies[3].

Sources

1. Grand View Research: Pharmaceutical Market Size, Share & Trends Report, 2030
2. Cognitive Market Research: Global Potassium Bitartrate CAS 868 14 4 Market Report 2024
3. Biospace: Evofem Reports $18.2 million of Phexxi Net Product Sales in 2023
4. Jarsking: Analysis of the Pharmaceutical Industry Market and Trends
5. Dataintelo: Potassium Bitartrate Market Research Report 2032