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Last Updated: December 24, 2024

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phexxi Drug Patent Profile


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When do Phexxi patents expire, 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

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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
Drug patent expirations by year for phexxi
Drug Prices for phexxi

See drug prices for phexxi

Recent Clinical Trials for phexxi

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

SponsorPhase
University of Hawaii FoundationEarly Phase 1
Queen's Medical CenterEarly Phase 1
ParexelPhase 3

See all phexxi clinical trials

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Evofem Inc PHEXXI citric acid; lactic acid; potassium bitartrate GEL;VAGINAL 208352-001 May 22, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Evofem Inc PHEXXI citric acid; lactic acid; potassium bitartrate GEL;VAGINAL 208352-001 May 22, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Evofem Inc PHEXXI citric acid; lactic acid; potassium bitartrate GEL;VAGINAL 208352-001 May 22, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Evofem Inc PHEXXI citric acid; lactic acid; potassium bitartrate GEL;VAGINAL 208352-001 May 22, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for phexxi

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

Country Patent Number Title Estimated Expiration
Japan 2022070924 アルギン酸をベースとする抗菌性化合物を使用して炎症と疾患を阻害するための組成物及び方法 ⤷  Subscribe
Canada 2402589 COMPOSITIONS ET PROCEDES PERMETTANT DE PIEGER ET D'INACTIVER LES MICROBES PATHOGENES ET LES SPERMATOZOIDES (COMPOSITIONS AND METHODS FOR TRAPPING AND INACTIVATING PATHOGENIC MICROBES AND SPERMATOZOA) ⤷  Subscribe
Australia 2001243431 ⤷  Subscribe
Mexico 2021001742 COMPOSICIONES Y METODOS PARA INHIBIR LA INFLAMACION Y LAS ENFERMEDADES UTILIZANDO UN COMPUESTO ANTIMICROBIANO CON BASE EN ACIDO ALGINICO. (COMPOSITIONS AND METHODS FOR INHIBITING INFLAMMATION AND DISEASES USING AN ALGINIC ACID-BASED ANTIMICROBIAL COMPOUND.) ⤷  Subscribe
New Zealand 703203 Compositions and methods for enhancing the efficacy of contraceptive microbicides ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Phexxi Market Analysis and Financial Projection Experimental

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.

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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. 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.