XACIATO Drug Patent Profile

Which patents cover Xaciato, and what generic alternatives are available?

Xaciato is a drug marketed by Organon Llc and is included in one NDA. There is one patent protecting this drug.

This drug has twelve patent family members in ten countries.

The generic ingredient in XACIATO is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xaciato

A generic version of XACIATO was approved as clindamycin phosphate by HIKMA on April 25^th, 1988.

Summary for XACIATO

International Patents:	12
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	2,414
Drug Prices:	Drug price information for XACIATO
What excipients (inactive ingredients) are in XACIATO?	XACIATO excipients list
DailyMed Link:	XACIATO at DailyMed

See drug prices for XACIATO

Pharmacology for XACIATO

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

US Patents and Regulatory Information for XACIATO

XACIATO is protected by one US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes	11,129,896
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes

International Patents for XACIATO

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

Country	Patent Number	Title	Estimated Expiration
Canada	2993012	FORMULATIONS ET TRAITEMENTS TOPIQUES (TOPICAL FORMULATIONS AND TREATMENTS)
Hungary	E056401
Lithuania	3324938
Mexico	2018000800	FORMULACIONES Y TRATAMIENTOS TOPICOS. (TOPICAL FORMULATIONS AND TREATMENTS.)
Poland	3324938
Portugal	3324938
Spain	2891754

Supplementary Protection Certificates for XACIATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624

Market Dynamics and Financial Trajectory for XACIATO

Introduction to XACIATO

XACIATO, a clindamycin phosphate vaginal gel 2%, is a treatment approved by the U.S. Food and Drug Administration (FDA) for bacterial vaginosis (BV) in females 12 years of age and older. Developed by Daré Bioscience, the drug has been licensed to Organon for commercialization, marking a significant milestone in the women’s health sector.

Commercialization and Market Performance

Organon's Role in Commercialization

Organon initiated commercial marketing activities for XACIATO in the fourth quarter of 2023. This move has been instrumental in driving the drug's market presence. The inclusion of XACIATO in Texas Medicaid's preferred drug list has further boosted its prescription growth, indicating increasing market acceptance[2].

Prescription Growth and Revenue

XACIATO has seen a steady increase in prescriptions, contributing to Daré Bioscience's revenue. In 2023, Daré received milestone payments from Organon, including a $1.0 million payment in July and an additional $1.8 million milestone payment in October, totaling $2.8 million in revenue related to XACIATO[1].

Financial Impact on Daré Bioscience

Revenue Contributions

XACIATO is a non-dilutive source of revenue for Daré Bioscience, providing royalty income. In 2023, the total revenue from XACIATO and other sources was approximately $2.8 million, with a significant portion coming from milestone payments related to XACIATO[1].

Non-Dilutive Funding

The commercial success of XACIATO has also facilitated non-dilutive funding for Daré Bioscience. For instance, XOMA Corporation acquired an economic interest in XACIATO, along with other Daré assets, for an upfront payment of $22 million. This transaction provided Daré with additional financial resources to advance its pipeline[4].

Financial Trajectory

Recent Financial Performance

In 2023, Daré Bioscience reported a net loss of approximately $30.1 million, despite the revenue generated from XACIATO and other sources. However, the company's financial health has been supported by various non-dilutive funding sources, including grants and royalty-backed financing structures[1].

Future Outlook

The financial trajectory for Daré Bioscience, influenced by XACIATO, looks promising. With over $20 million in non-dilutive funding secured, the company is well-positioned to advance its product development and clinical trials. The equity line agreement with Lincoln Park Capital Fund LLC and the royalty monetization transaction with XOMA Corporation further enhance Daré's financial stability[2][3].

Key Financial Metrics

Revenue Breakdown

• License Fee Revenue: $1.0 million in 2023[1].
• Milestone Revenue: $1.8 million in 2023[1].
• Royalty Revenue: $7,885 in 2023[1].

Operating Expenses

• General and Administrative (G&A) Expenses: Approximately $12.1 million in 2023[1].
• Research and Development (R&D) Expenses: Approximately $21.5 million in 2023, with a decrease anticipated in 2024[1].

Market Dynamics and Growth Potential

Market Acceptance

The inclusion of XACIATO in Texas Medicaid's preferred drug list and its steady prescription growth indicate strong market acceptance. This acceptance is crucial for the drug's long-term success and revenue generation[2].

Competitive Landscape

In the women’s health sector, particularly for bacterial vaginosis treatments, XACIATO stands out as an FDA-approved therapy. Its unique positioning and the backing of a global healthcare company like Organon enhance its competitive edge[4].

Future Catalysts

The advancement of Daré Bioscience's pipeline, including other women’s health products like Ovaprene and Sildenafil Cream, is expected to drive further growth. These products, along with XACIATO, represent significant advances in the women’s health category and have substantial growth potential[3].

"XACIATO™, an important therapy, becomes the fifth commercial asset in XOMA’s royalty portfolio, and our royalty monetization transaction with Daré also adds two first-in-category Phase 3 royalty assets that have the potential to create additional value for our shareholders," stated Brad Sitko, Chief Investment Officer at XOMA[4].

Conclusion

XACIATO's market dynamics and financial trajectory are closely tied to its commercial success and the strategic partnerships of Daré Bioscience. With increasing prescriptions, non-dilutive funding, and a strong market presence, XACIATO is poised to continue contributing to Daré's revenue and growth.

Key Takeaways

• Commercial Success: XACIATO has seen steady prescription growth and has been included in Texas Medicaid's preferred drug list.
• Non-Dilutive Funding: The drug has facilitated significant non-dilutive funding for Daré Bioscience through royalty monetization and grants.
• Financial Stability: Daré's financial health is supported by various funding sources, including equity line agreements and royalty-backed financing.
• Market Acceptance: Strong market acceptance indicates long-term revenue potential.
• Competitive Edge: XACIATO's unique positioning and FDA approval enhance its competitive edge in the women’s health sector.

FAQs

Q: What is XACIATO used for?

A: XACIATO is used for the treatment of bacterial vaginosis (BV) in females 12 years of age and older.

Q: Who commercializes XACIATO?

A: XACIATO is commercialized by Organon, a global women’s healthcare company.

Q: How has XACIATO impacted Daré Bioscience's revenue?

A: XACIATO has contributed significantly to Daré Bioscience's revenue through milestone payments and royalty income.

Q: What non-dilutive funding has Daré Bioscience received related to XACIATO?

A: Daré Bioscience has received over $20 million in non-dilutive funding, including grants and a $22 million royalty monetization transaction with XOMA Corporation.

Q: What is the future outlook for XACIATO and Daré Bioscience?

A: The future outlook is promising, with increasing prescriptions, non-dilutive funding, and a strong market presence supporting Daré's financial stability and growth.

Sources

1. Daré Bioscience Reports Full Year 2023 Financial Results and Provides Business Update - IR Daré Bioscience
2. Earnings call: Daré Bioscience reports Q3 financials, advances in women's health - Investing.com
3. Daré Bioscience Reports Second Quarter 2024 Financial Results - Stock Titan
4. XOMA Adds Economic Interests in Three First-in-Category Assets to Its Royalty and Milestone Portfolio - BioSpace