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CRESEMBA Drug Patent Profile

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

Cresemba is a drug marketed by Astellas and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-two patent family members in nineteen countries.

The generic ingredient in CRESEMBA is isavuconazonium sulfate. One supplier is listed for this compound. Additional details are available on the isavuconazonium sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Cresemba

Cresemba was eligible for patent challenges on March 6, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2030. This may change due to patent challenges or generic licensing.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for CRESEMBA

International Patents:	32
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	5
Drug Prices:	Drug price information for CRESEMBA
What excipients (inactive ingredients) are in CRESEMBA?	CRESEMBA excipients list
DailyMed Link:	CRESEMBA at DailyMed

See drug prices for CRESEMBA

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

Constraining patent/regulatory exclusivity:

TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER

NDA:

207500

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER

NDA:

207501

Dosage:

POWDER;INTRAVENOUS

^*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 CRESEMBA

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

Sponsor	Phase
Pfizer	Phase 4
Jeffrey Jenks, MD, MPH	Phase 3
Astellas Pharma Global Development, Inc.	Phase 3

See all CRESEMBA clinical trials

Pharmacology for CRESEMBA

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for CRESEMBA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CRESEMBA	Capsules	isavuconazonium sulfate	186 mg	207500	4	2024-09-06
CRESEMBA	For Injection	isavuconazonium sulfate	372 mg/vial	207501	2	2024-09-06

US Patents and Regulatory Information for CRESEMBA

CRESEMBA is protected by three US patents and fifteen FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER.

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
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes

Expired US Patents for CRESEMBA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015

International Patents for CRESEMBA

When does loss-of-exclusivity occur for CRESEMBA?

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

Australia

Austria

Canada

Denmark

European Patent Office

Germany

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 CRESEMBA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1902708	Compositions pharmaceutiques stabilisées et solides contenant au moins un médicament et procédé d'élaboration (Drug comprising stabilized pharmaceutical solid compositions and processes for their preparation)
China	109565370	新无线电的上传控制信令 (UPLOAD CONTROL SIGNALING FOR NEW RADIO)
Netherlands	300791

Supplementary Protection Certificates for CRESEMBA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280795	2015/073	Ireland		PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795	15C0096	France		PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795	512	Finland

CRESEMBA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cresemba (Isavuconazole)

Introduction

Cresemba, marketed under the generic name isavuconazole, is an antifungal medication developed by Basilea Pharmaceutica Ltd. and licensed to Pfizer for various regions. This article delves into the market dynamics and financial trajectory of Cresemba, highlighting its commercial success, regulatory approvals, and financial performance.

Regulatory Approvals and Market Coverage

Cresemba is approved in 76 countries worldwide, including the United States, most EU member states, and several countries in the Asia Pacific region and China. It is indicated for the treatment of invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate[4].

Global Sales Performance

The global sales of Cresemba have shown significant growth over the years. Between July 2022 and June 2023, total global in-market sales of Cresemba amounted to $421 million, representing a 19% year-on-year growth[1]. As of the 12 months between April 2023 and March 2024, global sales of Cresemba reached $489 million, marking a 24% year-on-year increase[4].

Regional Performance

Asia Pacific and China

Cresemba's sales performance in the Asia Pacific region and China has been particularly strong. In 2023, the sales in this region triggered a third sales milestone payment of $1.25 million from Pfizer to Basilea, highlighting the significant commercial potential of Cresemba in these markets[1].

Europe

In Europe, excluding the Nordic countries, Cresemba's sales have also been robust. A milestone payment of $25 million was triggered in 2024 due to the strong sales performance of Cresemba by Pfizer in this region[4].

Financial Performance of Basilea Pharmaceutica

Revenue Growth

Basilea has seen substantial revenue growth driven by Cresemba's success. In the financial year 2021, non-deferred revenue from Cresemba and another product, Zevtera, increased by 64.7% to CHF 128.8 million compared to the previous year[3].

For the first half of 2024, Basilea reported a 16.6% growth in royalties from Cresemba to CHF 42.8 million. The company has increased its total revenue guidance for 2024 to approximately CHF 196 million, reflecting the continued commercial success of Cresemba[5].

Milestone Payments

Milestone payments have been a significant contributor to Basilea's revenue. In 2021, upfront and milestone payments from partners amounted to CHF 49.4 million, a substantial increase from CHF 9.0 million in the previous year[3]. In 2024, Basilea received a $25 million milestone payment following strong Cresemba sales performance in Europe[4].

Operating Results and Profitability

Basilea has reported improved operating results and profitability. For the first half of 2024, the company achieved an operating result of CHF 9.3 million and a net profit of CHF 20.7 million. The full-year 2024 guidance indicates an expected operating result increase of 88% to CHF ~36 million and a net profit increase of 300% to CHF ~42 million compared to the previous year[5].

Strategic Focus and Future Outlook

Basilea is strategically focused on anti-infectives, with Cresemba being a key product. The company is exploring options to maximize the value of its oncology assets while maintaining a strong focus on its anti-infectives business. Sustainable profitability is expected from 2023 onwards, driven by the continued success of Cresemba[3].

Cost and Expense Management

Basilea has managed its costs effectively, with selling, general, and administrative expenses decreasing to CHF 15.3 million in the first half of 2024 compared to CHF 16.5 million in the same period of the previous year. The cost of products sold increased due to the significant rise in product revenue[5].

Market Need and Competitive Position

Cresemba serves a high medical need, particularly for patients with invasive mold infections. The drug's approval in multiple countries and its strong sales performance indicate its competitive position in the antifungal market.

"Cresemba continues to serve a high medical need and also reflects the significant commercial potential of Cresemba in this region," - David Veitch, Basilea’s Chief Executive Officer[1].

Conclusion

Cresemba has established itself as a leading antifungal medication with strong market dynamics and a robust financial trajectory. The drug's global sales growth, significant milestone payments, and Basilea's improved financial performance underscore its commercial success. As Basilea continues to focus on anti-infectives and optimize its business strategies, Cresemba is poised to remain a key driver of the company's growth and profitability.

Key Takeaways

• Global Sales Growth: Cresemba's global sales have grown significantly, reaching $489 million between April 2023 and March 2024.
• Regional Success: Strong sales performance in the Asia Pacific region, China, and Europe.
• Financial Performance: Basilea has seen substantial revenue growth and improved profitability driven by Cresemba.
• Milestone Payments: Significant milestone payments from Pfizer have contributed to Basilea's revenue.
• Strategic Focus: Basilea is focused on anti-infectives with a long-term outlook for sustainable profitability.
• Cost Management: Effective management of costs while increasing product revenue.

FAQs

Q: What is Cresemba used for?

A: Cresemba (isavuconazole) is used for the treatment of invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate.

Q: In how many countries is Cresemba approved?

A: Cresemba is approved in 76 countries worldwide, including the United States, most EU member states, and several countries in the Asia Pacific region and China.

Q: What was the total global sales of Cresemba between April 2023 and March 2024?

A: The total global sales of Cresemba between April 2023 and March 2024 amounted to $489 million.

Q: How much was the milestone payment received by Basilea from Pfizer in 2024?

A: Basilea received a $25 million milestone payment from Pfizer in 2024 due to strong Cresemba sales performance in Europe.

Q: What is Basilea's expected total revenue for 2024?

A: Basilea has increased its total revenue guidance for 2024 to approximately CHF 196 million.

Sources

1. Basilea Pharmaceutica Ltd. - Continued strong Cresemba® (isavuconazole) sales performance in Asia Pacific and China triggers third sales milestone payment for the region from Pfizer this year[1].
2. Basilea Pharmaceutica Ltd. - Basilea reports strong financial results for half-year 2021 with 26% growth year-on-year[2].
3. Basilea Pharmaceutica Ltd. - Basilea to become a leading anti-infectives company backed by strong financial results 2021[3].
4. Nasdaq - Basilea Receives $25 Mln Milestone Payment Following Strong Cresemba Sales Performance[4].
5. Biospace - Basilea reports strong 2024 half-year results and significantly increases full-year revenue and profit guidance[5].