SOFDRA Drug Patent Profile

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

Sofdra is a drug marketed by Botanix Sb and is included in one NDA. There are seventeen patents protecting this drug.

This drug has one hundred and fifty-two patent family members in twenty-six countries.

The generic ingredient in SOFDRA is sofpironium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sofpironium bromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Sofdra

Sofdra will be eligible for patent challenges on June 20, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 20, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SOFDRA

International Patents:	152
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	3
What excipients (inactive ingredients) are in SOFDRA?	SOFDRA excipients list
DailyMed Link:	SOFDRA at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217347

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.

US Patents and Regulatory Information for SOFDRA

SOFDRA is protected by seventeen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,123,325		Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes
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	11,034,652		Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	9,492,429		Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	8,628,759
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,584,715		Y	Y

International Patents for SOFDRA

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

Country	Patent Number	Title	Estimated Expiration
China	110917124
Portugal	3325487
European Patent Office	2968267	ESTERS DE ANTICHOLINERGIQUES DOUX POUR LE TRAITEMENT DE L'HYPERHIDROSE (SOFT ANTICHOLINERGIC ESTERS FOR THE TREATMENT OF HYPERHIDROSIS)
Brazil	112021023241	Forma cristalina de brometo de sofpironium e método de preparação da mesma
South Korea	20180030893
Hungary	E062905
China	108137612

SOFDRA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for SOFDRA (Sofpironium)

Introduction to SOFDRA

SOFDRA (sofpironium) is a significant addition to the pediatric drugs market, having received FDA approval in June 2024 for the treatment of primary axillary hyperhidrosis in children 9 years of age and older. This approval marks a crucial milestone in addressing a specific and often overlooked condition in pediatric populations.

Market Approval and Regulatory Support

The FDA approval of SOFDRA is a testament to the stringent regulatory standards and the thorough evaluation process that new drugs undergo. This approval not only validates the efficacy and safety of SOFDRA but also enhances trust among healthcare providers and parents, encouraging the early adoption of this treatment[4].

Market Drivers

Increasing Prevalence of Pediatric Health Issues

The growing awareness among parents about pediatric health issues, coupled with the increasing prevalence of various conditions, drives the demand for specialized pediatric medications. SOFDRA, being the first drug approved for primary axillary hyperhidrosis in children, fills a critical gap in the market and is poised to benefit from this trend[1].

Regulatory Backing

The support from regulatory bodies such as the FDA is crucial for the success of any new drug. The FDA's initiative to publish updates in the American Academy of Pediatrics' monthly magazine helps in disseminating information and fostering trust among pediatricians, which can lead to higher adoption rates of newly approved drugs like SOFDRA[4].

Competitive Landscape

Major Players in the Pediatric Drugs Market

The pediatric drugs market is dominated by major pharmaceutical companies such as Novartis AG, Pfizer Inc., Sanofi, Johnson & Johnson Services, Inc., and Bayer AG. While SOFDRA is not developed by these giants, its approval and market presence are significant in a landscape where innovation and regulatory approval are key differentiators[1][4].

Financial Trajectory

Development and Approval Costs

The development of any new drug, including SOFDRA, involves substantial costs. The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. However, the specific financial details for SOFDRA's development are not publicly disclosed[3].

Revenue Potential

Given the niche market SOFDRA serves, its revenue potential is significant. The pediatric drugs market as a whole is expected to grow at a CAGR of 12.3% from 2024 to 2031, reaching USD 333 billion by 2031. While SOFDRA's specific revenue projections are not available, it is likely to contribute to this growth by addressing a previously unmet medical need[1].

Investment and Funding

Companies investing in pharmaceutical research and development, such as those behind SOFDRA, often face high costs and risks. However, successful drugs can generate substantial returns. For instance, blockbuster drugs like Humira have generated over $20 billion in annual revenue at their peak, highlighting the potential financial rewards for successful pediatric drugs like SOFDRA[3].

Challenges and Opportunities

Drug Development Costs and Regulatory Hurdles

Despite the potential rewards, the development of pediatric drugs like SOFDRA faces significant challenges, including high development costs and stringent regulatory hurdles. The probability of success for a drug candidate entering clinical trials is only around 10%, underscoring the risks involved[3].

Innovation and Affordability

The pediatric drugs market must balance innovation with affordability and access. Companies must navigate these complexities to ensure that drugs like SOFDRA are not only effective but also accessible to the target population. This balance is crucial for long-term market success[4].

Illustrative Statistics

• The global pharmaceutical market revenue is projected to be $1.15 trillion in 2024 and is forecasted to exceed $1.4 trillion by 2028, driven by the escalating global burden of chronic diseases[3].
• The pediatric drugs market is expected to grow at a CAGR of 12.3% from 2024 to 2031, reaching USD 333 billion by 2031[1].

Expert Insights

"The pediatric segment is likely to remain a critical area of focus within the broader healthcare landscape. Companies are now focusing on developing combination vaccines and novel vaccine delivery systems that are more suitable for children," - Industry expert on the growing importance of pediatric drugs[4].

Geographic Expansion

As developing nations gain better access to healthcare, companies are looking to register existing drugs and conduct local clinical trials. This geographic expansion could provide additional growth opportunities for SOFDRA and other pediatric drugs[1].

Key Takeaways

• FDA Approval: SOFDRA received FDA approval in June 2024 for treating primary axillary hyperhidrosis in children.
• Market Drivers: Increasing awareness among parents and regulatory support drive the demand for pediatric medications.
• Financial Trajectory: The drug has significant revenue potential within the growing pediatric drugs market.
• Challenges: High development costs and regulatory hurdles are key challenges.
• Opportunities: Geographic expansion and innovation in drug delivery systems offer future growth opportunities.

FAQs

Q: What is SOFDRA used for? A: SOFDRA (sofpironium) is used for the treatment of primary axillary hyperhidrosis in children 9 years of age and older.

Q: When was SOFDRA approved by the FDA? A: SOFDRA was approved by the FDA in June 2024.

Q: What are the key drivers of the pediatric drugs market? A: Increasing prevalence of pediatric diseases, heightened awareness among parents, and regulatory support are key drivers.

Q: How much is the pediatric drugs market expected to grow by 2031? A: The pediatric drugs market is expected to reach USD 333 billion by 2031, growing at a CAGR of 12.3% from 2024 to 2031.

Q: What are the main challenges faced by pediatric drug developers like SOFDRA? A: High development costs, regulatory hurdles, and the need to balance innovation with affordability and access are significant challenges.

Cited Sources

1. Coherent Market Insights: Pediatric Drugs Market Trends, Size, Share & Analysis 2031.
2. Biospace: Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results.
3. DrugBank Blog: Investment Trends in Pharmaceutical Research.
4. PR Newswire: Global Pediatric Drugs Market is Predicted to Resister Growth at a CAGR of 5 by 2030.