PHEXXI Drug Patent Profile

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

Phexxi is a drug marketed by Evofem Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-five patent family members in twenty-three countries.

The generic ingredient in PHEXXI is citric acid; lactic acid; potassium bitartrate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; lactic acid; potassium bitartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Phexxi

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for PHEXXI

International Patents:	65
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Drug Prices:	Drug price information for PHEXXI
What excipients (inactive ingredients) are in PHEXXI?	PHEXXI excipients list
DailyMed Link:	PHEXXI at DailyMed

See drug prices for PHEXXI

Recent Clinical Trials for PHEXXI

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

Sponsor	Phase
University of Hawaii Foundation	Early Phase 1
Queen's Medical Center	Early Phase 1
Parexel	Phase 3

See all PHEXXI clinical trials

Pharmacology for PHEXXI

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

Paragraph IV (Patent) Challenges for PHEXXI

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 PHEXXI

PHEXXI is protected by five US patents.

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	11,337,989
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	11,439,610		Y	Y
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes	11,992,472

Expired US Patents for PHEXXI

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 PHEXXI

See the table below for patents covering PHEXXI around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2002126560
China	1431895
Austria	489937

Market Dynamics and Financial Trajectory for Phexxi

Introduction

Phexxi, a hormone-free, locally-acting contraceptive gel developed by Evofem Biosciences, has been making significant strides in the women's health market since its U.S. commercial launch in 2020. Here, we delve into the market dynamics and financial trajectory of Phexxi, highlighting key milestones, challenges, and future prospects.

Market Demand and Growth

Phexxi has consistently demonstrated strong market demand, leading to consecutive years of net sales growth. For the year ended December 31, 2023, Evofem reported $18.2 million in net product sales, a notable increase from the $16.8 million in the prior year[1][2][4].

This growth is attributed to several factors, including improved reimbursement rates and a price increase that took effect on October 1, 2022. The expansion of coverage and reimbursement, such as the removal of prior authorization for Phexxi for 1.8 million lives in Washington state and a negotiated rebate with Medi-Cal, have also contributed to the increased sales[1][3][4].

Cost Management and Operational Efficiency

Evofem has shown remarkable fiscal discipline, significantly reducing its operating expenses. In 2023, total operating expenses decreased by 64% to $36.1 million, compared to $101.0 million in the prior year. This reduction was driven by a 73% decrease in selling and marketing costs and an 88% cut in research and development expenses following the suspension of clinical activities in the fourth quarter of 2022[1][2][3].

Financial Performance

The financial performance of Evofem has improved substantially. The loss from operations for 2023 was $17.8 million, a significant improvement from the $84.1 million loss in the prior year. For the fourth quarter of 2023, the loss from operations was $3.4 million, down from $12.1 million in the corresponding period of 2022[1][2].

Sales and Marketing Efficiency

The sales and marketing expenses as a percentage of net sales have been optimized, reaching 54% in the fourth quarter of 2023, the most favorable ratio since Phexxi's launch in 2020. This indicates a more efficient use of resources and a strong market reception of the product[1][2].

Acquisition by Aditxt

In December 2023, Evofem entered into a definitive agreement to be acquired by Aditxt, Inc. (Nasdaq: ADTX). This acquisition is expected to close in the second half of 2024 and is seen as a strategic move to accelerate Evofem's growth trajectory and expand into a multi-product women's health franchise. The merger aims to leverage synergies and economies of scale to enhance Evofem's market position and product portfolio[1][3][5].

Market Position and Competitive Advantage

Phexxi's unique position as the first and only FDA-approved hormone-free, locally-acting contraceptive gel has given it a competitive edge. The product's effectiveness and the growing consumer trend towards health-conscious, hormone-free products have contributed to its strong market demand. The expansion of use cases, such as supplemental contraception for women taking GLP-1 agonists like Mounjaro and Zepbound, further solidifies Phexxi's market position[5].

Future Growth Drivers

Key growth drivers for 2024 include the ongoing success in executing Phexxi's market access strategy, such as the recent wins in reimbursement and coverage. Additionally, the increasing use of Phexxi as a supplemental contraceptive method among women taking certain medications that may reduce the effectiveness of oral contraceptives is expected to drive growth[1][3][5].

Challenges and Risks

Despite the positive trajectory, Evofem faces challenges such as regulatory risks and integration complexities associated with the acquisition by Aditxt. The company's small market capitalization and significant operating loss margin also pose risks. However, the strategic cost reductions and improved operational efficiency have positioned the company for better financial health[2][3].

Consumer Demand and Product-Market Fit

The strong consumer demand for Phexxi is a testament to its effective value proposition and brand loyalty. The product's ability to meet the growing consumer trend towards hormone-free and health-conscious products has been a critical factor in its success. As Saundra Pelletier, CEO of Evofem Biosciences, noted, "Strong consumer demand for Phexxi and the expansion of coverage and reimbursement enabled us to achieve our third consecutive year of revenue growth"[3].

Regulatory and Patent Landscape

Phexxi has recently been granted a new U.S. patent covering its composition of matter, further securing its market position. This patent protection is crucial for maintaining competitive advantage and ensuring long-term growth[5].

Key Takeaways

• Consecutive Sales Growth: Phexxi has achieved three consecutive years of net sales growth.
• Cost Efficiency: Significant reductions in operating expenses, particularly in selling and marketing costs.
• Improved Financial Performance: Substantial improvement in loss from operations.
• Acquisition by Aditxt: Expected to accelerate growth and expand the product portfolio.
• Market Position: Strong competitive advantage as the first and only FDA-approved hormone-free, locally-acting contraceptive gel.
• Future Growth Drivers: Ongoing market access strategies and increasing use as a supplemental contraceptive method.

FAQs

Q: What are the key factors driving the growth of Phexxi sales? A: Improved reimbursement rates, a price increase effective October 1, 2022, and the expansion of coverage and reimbursement are key drivers.

Q: How has Evofem managed its operating expenses? A: Evofem reduced its total operating expenses by 64% in 2023, primarily through a 73% decrease in selling and marketing costs and an 88% cut in research and development expenses.

Q: What is the significance of the acquisition by Aditxt? A: The acquisition is expected to accelerate Evofem's growth trajectory and expand its product portfolio into a multi-product women's health franchise.

Q: What unique market position does Phexxi hold? A: Phexxi is the first and only FDA-approved hormone-free, locally-acting contraceptive gel, giving it a competitive edge in the market.

Q: What are the potential challenges for Evofem moving forward? A: Regulatory risks, integration complexities with Aditxt, and the company's small market capitalization and significant operating loss margin are potential challenges.

Sources

1. PR Newswire: Evofem Reports $18.2 million of Phexxi Net Product Sales in 2023.
2. Investing.com: Evofem slashes expenses, sees Phexxi sales growth in 2023.
3. Stocktitan: Evofem Biosciences Announces Strong Preliminary Results, Record Phexxi Net Sales for Fiscal 2023.
4. PR Newswire: Evofem Biosciences Announces Strong Preliminary Results, Record Phexxi Net Sales for Fiscal 2023.
5. BioSpace: Evofem Announces Issuance of New U.S. Patent Covering Phexxi Composition of Matter.