SOFPIRONIUM BROMIDE - Generic Drug Details

What are the generic sources for sofpironium bromide and what is the scope of patent protection?

Sofpironium bromide is the generic ingredient in one branded drug marketed by Botanix Sb and is included in one NDA. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofpironium bromide has one hundred and fifty-two patent family members in twenty-six countries.

There is one drug master file entry for sofpironium bromide. One supplier is listed for this compound.

Summary for SOFPIRONIUM BROMIDE

International Patents:	152
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
Patent Applications:	11
What excipients (inactive ingredients) are in SOFPIRONIUM BROMIDE?	SOFPIRONIUM BROMIDE excipients list
DailyMed Link:	SOFPIRONIUM BROMIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

GEL, METERED;TOPICAL

^*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 SOFPIRONIUM BROMIDE

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

Sponsor	Phase
Brickell Biotech, Inc.	Phase 3
Brickell Biotech, Inc.	Phase 2

See all SOFPIRONIUM BROMIDE clinical trials

US Patents and Regulatory Information for SOFPIRONIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	10,947,192
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,084,788		Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	10,959,983
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	10,961,191
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	10,952,990
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	8,147,809		Y	Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,584,715		Y	Y

International Patents for SOFPIRONIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Malaysia	185814	FORMULATION FOR SOFT ANTICHOLINERGIC ANALOGS
Japan	6461214
Singapore	11201607480S
South Korea	20220119517
Japan	6694908
Mexico	2018000918
Japan	2020189856	ソフピロニウム臭化物の結晶形態及びその製造方法 (CRYSTALLINE FORM OF SOFPIRONIUM BROMIDE AND PREPARATION METHOD THEREOF)

SOFPIRONIUM BROMIDE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Sofpironium Bromide

Introduction to Sofpironium Bromide

Sofpironium bromide is a retrometabolically-designed new chemical entity belonging to the class of anticholinergic medications. It is primarily developed as a topical therapy for the treatment of primary axillary hyperhidrosis, or excessive underarm sweating. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Opportunity and Need

The market for hyperhidrosis treatments is significant, with over 16 million people suffering from the condition in the United States alone. The hyperhidrosis treatment market is estimated to be around $1.6 billion annually and is projected to grow to $2.8 billion by 2030[3].

Clinical Development and Regulatory Status

Sofpironium bromide gel, 15%, has completed a U.S. Phase 3 pivotal clinical program, demonstrating positive results with all co-primary and secondary endpoints being statistically significant and no treatment-related serious adverse events[3].

In December 2022, the U.S. FDA accepted the New Drug Application (NDA) submission for sofpironium bromide gel, 15%, which was a significant milestone for the drug's approval process[2].

Market Research and Stakeholder Feedback

Botanix Pharmaceuticals conducted initial market research involving physicians, payers, and patients. The feedback was positive, highlighting the significant market potential for sofpironium bromide and the unmet need for effective and accessible treatments for axillary hyperhidrosis[3].

Ownership and Licensing Agreements

Originally developed by Brickell Biotech, the rights to sofpironium bromide were acquired by Botanix Pharmaceuticals in May 2022. Under the agreement, Botanix acquired all assets related to sofpironium bromide and agreed to pay Brickell (now Fresh Tracks Therapeutics) upfront and potential milestone payments of up to $177 million, including tiered earn-out payments on net sales[1][4].

Financial Transactions and Milestones

• Upfront and Milestone Payments: Fresh Tracks received an upfront payment of $9 million and is eligible for near-term regulatory milestone payments of up to $9 million over 18 months. Additional success-based regulatory and sales milestone payments could reach up to $168 million[1][4].
• Buyout of Future Payments: In July 2023, Fresh Tracks agreed to sell its rights to forthcoming event-based milestones and profits on net sales of sofpironium bromide to Botanix for $8.25 million. This deal was seen as a win-win, strengthening Fresh Tracks' financial position without equity dilution[4].

Revenue and Expenses

Fresh Tracks Therapeutics reported significant revenue in 2022 primarily from contract revenue related to the asset purchase agreement (APA) and transition services agreement (TSA) with Botanix. This included an upfront payment of $3 million, a milestone payment of $2 million, and fees for consulting services and reimbursed development expenditures[2].

• Revenue Breakdown:

  • Contract revenue: $6.851 million
  • Royalty revenue: $92,000
  • Total revenue: $6.943 million for the year ended December 31, 2022[2].

• Research and Development Expenses:

  • Reduced from $28.2 million in 2021 to $14.0 million in 2022, primarily due to lower clinical expenses related to sofpironium bromide[2].

Cash and Funding Position

As of December 31, 2022, Fresh Tracks had $8.7 million in cash and cash equivalents. The company raised an additional $6.6 million in March 2023 through an at-the-market equity offering program, ensuring sufficient funding for operations for at least the next 12 months[2].

Competitive Landscape

The hyperhidrosis treatment market is competitive, with existing treatments such as self-administered topical antiperspirants, Qbrexza (glycopyrronium) 2.4% topical cloth, and off-label use of oral and compounded topical anticholinergics. Sofpironium bromide's success will depend on its ability to offer a safer, more effective, and more convenient treatment option compared to these competitors[5].

Strategic Focus and Future Development

Following the sale of sofpironium bromide rights, Fresh Tracks has shifted its strategic focus to developing novel therapeutics in the immunology and inflammatory fields. The company is advancing its pipeline, including a first-in-human Phase 1 clinical study for its lead DYRK1A inhibitor, BBI-02, and progressing the development of its lead STING inhibitor, BBI-10[1].

Key Takeaways

• Market Potential: Sofpironium bromide addresses a significant unmet need in the hyperhidrosis treatment market.
• Regulatory Progress: The drug has completed Phase 3 clinical trials and had its NDA accepted by the FDA.
• Financial Transactions: Botanix acquired the rights to sofpironium bromide with substantial upfront and milestone payments.
• Revenue and Expenses: Fresh Tracks generated significant revenue from the APA and TSA with Botanix.
• Competitive Landscape: The drug must compete with existing hyperhidrosis treatments but has shown promising results.
• Strategic Focus: Fresh Tracks is now focused on developing novel therapeutics in immunology and inflammatory fields.

FAQs

Q: What is sofpironium bromide used for? A: Sofpironium bromide is a topical therapy used for the treatment of primary axillary hyperhidrosis, or excessive underarm sweating.

Q: Who currently owns the rights to sofpironium bromide? A: Botanix Pharmaceuticals acquired the rights to sofpironium bromide from Fresh Tracks Therapeutics (formerly Brickell Biotech) in May 2022.

Q: What were the financial terms of the acquisition? A: Botanix paid Fresh Tracks $9 million upfront and agreed to potential milestone payments of up to $177 million, including tiered earn-out payments on net sales.

Q: What is the current regulatory status of sofpironium bromide? A: The U.S. FDA accepted the NDA submission for sofpironium bromide gel, 15%, in December 2022, with a decision expected in the third quarter of 2023.

Q: How does sofpironium bromide compare to existing treatments for hyperhidrosis? A: Sofpironium bromide has shown positive Phase 3 data with no treatment-related serious adverse events, positioning it as a potentially safer and more effective treatment option compared to existing therapies.

Cited Sources

1. GlobeNewswire: Brickell Biotech Announces Sale of Sofpironium Bromide to Botanix Pharmaceuticals.
2. GlobeNewswire: Fresh Tracks Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update.
3. Aspect Huntley: Initial Market Research Sofpironium Bromide.
4. Clinical Trials Arena: Deal focus: Fresh Tracks discloses its $8.25m buyout from Botanix.
5. Annual Reports: BRICKELL BIOTECH, INC. - Annual Reports.