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SOLOSEC Drug Patent Profile

When do Solosec patents expire, and when can generic versions of Solosec launch?

Solosec is a drug marketed by Evofem Inc and is included in one NDA. There are ten patents protecting this drug.

This drug has sixteen patent family members in five countries.

The generic ingredient in SOLOSEC is secnidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the secnidazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Solosec

Solosec was eligible for patent challenges on September 15, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 4, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SOLOSEC

International Patents:	16
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	2
Patent Applications:	615
Drug Prices:	Drug price information for SOLOSEC
What excipients (inactive ingredients) are in SOLOSEC?	SOLOSEC excipients list
DailyMed Link:	SOLOSEC at DailyMed

See drug prices for SOLOSEC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SOLOSEC

Constraining patent/regulatory exclusivity:

10,849,884

NDA:

209363

Dosage:

GRANULE;ORAL

^*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.

Recent Clinical Trials for SOLOSEC

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

Sponsor	Phase
Lupin Research Inc	Phase 3
Lupin Research Inc	Phase 4

See all SOLOSEC clinical trials

Pharmacology for SOLOSEC

Drug Class

Nitroimidazole Antimicrobial

US Patents and Regulatory Information for SOLOSEC

SOLOSEC is protected by thirty-two US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,849,884.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	11,324,721		Y
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	10,335,390		Y
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	11,020,377		Y
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	10,857,133		Y

International Patents for SOLOSEC

When does loss-of-exclusivity occur for SOLOSEC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Japan

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SOLOSEC around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2959414	SECNIDAZOLE UTILISE DANS LE TRAITEMENT D'UNE VAGINOSE BACTERIENNE (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Japan	6487534
World Intellectual Property Organization (WIPO)	2016037131
Japan	6637624
Australia	2018203882	Secnidazole for use in the treatment of bacterial vaginosis
Japan	2021042246	細菌性膣炎の治療に使用するためのセクニダゾール (SECNIDAZOLE FOR USE IN TREATMENT OF BACTERIAL VAGINOSIS)

SOLOSEC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SOLOSEC

Introduction to SOLOSEC

SOLOSEC®, a single-dose oral antimicrobial agent, has been a significant player in the women's health sector, particularly in treating bacterial vaginosis (BV) and trichomoniasis. Recently, the drug has changed hands from Lupin Limited to Evofem Biosciences, marking a pivotal shift in its market dynamics and financial trajectory.

The Divestiture and Acquisition

In July 2024, Lupin Limited divested its U.S. Commercial Women's Health Specialty Business, including SOLOSEC, to Evofem Biosciences. This move aligns with Lupin's strategic plan to focus on therapeutic areas such as respiratory and neurological diseases, where they can leverage existing synergies[1][4][5].

Financial Implications for Lupin

The divestiture could yield up to $84 million for Lupin, contingent on future milestones. This financial infusion is expected to help Lupin reallocate resources to more synergistic business areas, potentially improving operational efficiency and profitability. The immediate liquidity and strategic clarity from this divestiture may also positively impact Lupin's stock price in the short term[1][4][5].

Strategic Benefits for Evofem

For Evofem, the acquisition of SOLOSEC is a strategic milestone that enhances its women's health portfolio. SOLOSEC, being FDA-approved for both BV and trichomoniasis, addresses significant market opportunities in women's health. Evofem plans to leverage its existing commercial infrastructure and strong relationships with healthcare providers to maximize the growth potential of SOLOSEC[1][4][5].

Market Positioning and Growth Potential

SOLOSEC is the only single-dose oral prescription approved to treat both BV and trichomoniasis. This unique positioning allows Evofem to offer a comprehensive solution for common sexual health infections, potentially strengthening its market presence and offering cross-selling opportunities. The ease of use of SOLOSEC, with one oral dose providing a complete course of treatment, is another factor that could drive its adoption and revenue growth[1][4].

Financial Performance and Projections

Evofem's Q3 2024 financial results reflect the mixed impact of the acquisition. While net product sales decreased by 12% to $4.5 million, the company saw a 31% improvement in operating loss to $2.4 million compared to the previous year. The acquisition of SOLOSEC and other strategic moves, such as the commercial agreement for Phexxi in the Middle East, are expected to diversify and strengthen Evofem's revenue streams in the long term[2][3].

Integration and Execution Risks

The success of Evofem's strategy hinges on its ability to effectively market and distribute SOLOSEC. Integration risks and execution challenges are inherent in such acquisitions, and investors will closely monitor Evofem's performance in meeting the contingent milestones and driving growth from the acquisition[1][2][3].

Market Expansion and Collaborations

Evofem has also forged a commercial agreement for Phexxi in the Middle East, starting with the UAE, and launched a market development collaboration with Pearsanta for endometriosis diagnostics. These moves indicate a broader strategy to expand its market reach and diversify its product portfolio, which could further enhance the financial trajectory of SOLOSEC and other Evofem products[2][3].

Investor Perspective

Retail investors should be aware that while such divestitures and acquisitions can streamline operations and open new revenue streams, they also come with risks. The volatility in Evofem's stock price will likely reflect market participants' scrutiny of the company's ability to integrate and drive growth from the acquisition. Long-term success will depend on Evofem’s execution capabilities and market dynamics[1][2][5].

Key Takeaways

• Strategic Alignment: The divestiture aligns with Lupin's focus on respiratory and neurological diseases, while the acquisition enhances Evofem's women's health portfolio.
• Financial Potential: Lupin could receive up to $84 million based on future milestones, and Evofem expects long-term revenue growth from SOLOSEC.
• Market Positioning: SOLOSEC's unique FDA approval for both BV and trichomoniasis positions it strongly in the women's health market.
• Integration Risks: Success depends on Evofem's ability to effectively market and distribute SOLOSEC.
• Market Expansion: Evofem's strategic moves include expanding into the Middle East and collaborating on endometriosis diagnostics.

FAQs

What is SOLOSEC used for?

SOLOSEC is an FDA-approved single-dose oral antimicrobial agent used to treat bacterial vaginosis (BV) and trichomoniasis in individuals aged 12 and older[1][4].

Why did Lupin divest its U.S. Commercial Women's Health Specialty Business?

Lupin divested its U.S. Commercial Women's Health Specialty Business to focus on therapeutic areas with synergistic potential, such as respiratory and neurological diseases[1][4].

How much could Lupin receive from the divestiture?

Lupin could receive up to $84 million based on future contingent milestones[1][4].

What are the strategic benefits for Evofem from acquiring SOLOSEC?

The acquisition enhances Evofem's women's health portfolio, leverages its existing commercial infrastructure, and offers a comprehensive solution for common sexual health infections[1][4].

What are the financial implications for Evofem from the acquisition?

Evofem's Q3 2024 results showed a mixed financial picture, with a 31% improvement in operating loss but a 12% decrease in net product sales. Long-term revenue growth is expected from the acquisition[2][3].

Sources

1. Lupin Divests U.S. Commercial Women's Health Specialty Business to Evofem, including SOLOSEC - Stock Titan
2. Evofem Biosciences Announces Financial Results for the Third Quarter of 2024 - Stock Titan
3. Evofem Biosciences Announces Financial Results for the Third Quarter of 2024 - PR Newswire
4. Lupin Sells U.S. Women's Health Business to Evofem, Including SOLOSEC - Synapse
5. Evofem expands portfolio with SOLOSEC acquisition - Investing.com