RYDAPT Drug Patent Profile

When do Rydapt patents expire, and what generic alternatives are available?

Rydapt is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-two patent family members in twenty-seven countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rydapt

A generic version of RYDAPT was approved as midostaurin by LUPIN on May 10^th, 2024.

Summary for RYDAPT

International Patents:	62
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	12
Patent Applications:	3,851
Drug Prices:	Drug price information for RYDAPT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYDAPT
What excipients (inactive ingredients) are in RYDAPT?	RYDAPT excipients list
DailyMed Link:	RYDAPT at DailyMed

See drug prices for RYDAPT

Recent Clinical Trials for RYDAPT

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

Sponsor	Phase
Baptist Health South Florida	Phase 1/Phase 2
Jazz Pharmaceuticals	Phase 1/Phase 2
Technische Universität Dresden	Phase 1/Phase 2

See all RYDAPT clinical trials

Pharmacology for RYDAPT

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Paragraph IV (Patent) Challenges for RYDAPT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYDAPT	Capsules	midostaurin	25 mg	207997	4	2021-04-28

US Patents and Regulatory Information for RYDAPT

RYDAPT is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	AB	RX	Yes	Yes	8,575,146
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	AB	RX	Yes	Yes	7,973,031

Expired US Patents for RYDAPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	8,222,244

EU/EMA Drug Approvals for RYDAPT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Ltd	Rydapt	midostaurin	EMEA/H/C/004095 Rydapt is indicated:in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive (see section 4.2);as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL).	Authorised	no	no	yes	2017-09-18

International Patents for RYDAPT

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	1638574
Norway	20042123
Taiwan	200512213	New use of staurosporine derivatives
South Korea	20050040842
Mexico	PA05013722	NUEVOS USOS FARMACEUTICOS DE DERIVADOS DE ESTAUROSPORINA. (NEW PHARMACEUTICAL USES OF STAUROSPORINE DERIVATIVES.)
Taiwan	I302836

Supplementary Protection Certificates for RYDAPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638574	LUC00055	Luxembourg		PRODUCT NAME: MIDOSTAURINE OU UN SEL DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1218 20170920
1638574	17C1063	France		PRODUCT NAME: MIDOSTAURINE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	659	Finland
1638574	300917	Netherlands		PRODUCT NAME: MIDOSTAURINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	122018000016	Germany		PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170918
1638574	293 1-2018	Slovakia		PRODUCT NAME: MIDOSTAURIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1218 20170920

Market Dynamics and Financial Trajectory for RYDAPT

Overview of RYDAPT

RYDAPT, also known as midostaurin, is a targeted therapy used primarily for the treatment of various types of cancer, including Acute Myeloid Leukemia (AML) with FLT3 mutations, Aggressive Systemic Mastocytosis (ASM), Systematic Mastocytosis with hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)[1][2][5].

Market Size and Growth

The global RYDAPT market is projected to experience significant growth over the forecast period. As of 2022, the market size was estimated to be around USD 371.1 million. By 2031, it is expected to reach USD 2619.01 million, exhibiting a Compound Annual Growth Rate (CAGR) of 21.4%[1].

Market Segmentation

By Type

The RYDAPT market can be segmented based on the type of cancer it treats, including AML, ASM, SM-AHN, and MCL. The AML segment is anticipated to lead the market during the forecast period due to the increasing prevalence of this type of leukemia[1][4].

By Application

The market is also segmented by application, with the hospital segment expected to dominate due to the complex nature of the treatments involved. Pharmacies also play a significant role but to a lesser extent[1][4].

By Sales Channel

RYDAPT is available through both online and offline sales channels, with offline channels, such as hospitals and pharmacies, being more prominent due to the need for medical supervision and administration[4].

Driving Factors

Increased Lifespan and Efficacy

One of the primary drivers of the RYDAPT market is its ability to increase the lifespan of patients and achieve complete remission quickly. Patients can achieve complete remission within 60 days, which significantly enhances their life expectancy and quality of life[1].

Versatility in Treatment

RYDAPT is not limited to treating a single type of leukemia; it can be used for various categories of cancer, including AML, FLT3, ASM, SM-AHN, and MCL. This versatility increases its demand globally[1].

FDA Approval and Clinical Trials

The FDA approval of RYDAPT for treating FLT3 mutated AML and other mastocytosis-related conditions has bolstered its market position. Clinical trials have shown that RYDAPT, when combined with chemotherapy, improves the completion rate of induction and consolidation therapy compared to placebo[2].

Restraining Factors

Side Effects

Despite its efficacy, RYDAPT is associated with several adverse reactions, including febrile neutropenia, nausea, mucositis, vomiting, and QT prolongation. These side effects can lead to treatment discontinuation and are a significant restraining factor for the market[2].

COVID-19 Impact

The COVID-19 pandemic had a negative impact on the RYDAPT market, reducing demand across all regions compared to pre-pandemic levels. However, the market is expected to recover as demand returns to pre-pandemic levels[1].

Regional Insights

North America

North America is expected to dominate the RYDAPT market during the forecast period, holding around three-fourths of the market share in terms of production and sales. The high incidence of leukemia in the region, particularly in the United States, drives this dominance. According to the American Cancer Society, there were approximately 60,650 new cases of leukemia in 2022, with 20,050 cases of Acute Myeloid Leukemia (AML)[1][4].

Other Regions

Other significant regions include Europe, Asia-Pacific, and South America. These regions are also expected to see growth, although at a slower pace compared to North America. The increasing awareness and incidence of cancer in these regions will drive the demand for RYDAPT[4].

Key Industry Players

Novartis

Novartis is the leading company in the global RYDAPT market. As the sole manufacturer of RYDAPT, Novartis holds a significant market share and is responsible for the drug's distribution and marketing[1][4].

Financial Trajectory

Revenue Projections

The financial trajectory of RYDAPT is highly promising, with the market expected to grow from USD 371.1 million in 2022 to USD 2619.01 million by 2031. This growth is driven by the increasing demand for effective cancer treatments and the drug's proven efficacy in clinical trials[1].

Investment and Research

The market's growth is also supported by ongoing research and development in the pharmaceutical sector. Companies are investing heavily in understanding the molecular mechanisms of cancer and developing targeted therapies like RYDAPT. This investment is expected to continue, driving innovation and market expansion[4].

Competitive Scenario

The competitive landscape of the RYDAPT market is currently dominated by Novartis, with no generic version of the drug available. However, other pharmaceutical companies, such as Lupin, are also involved in the broader market for cancer treatments, which could potentially impact the competitive dynamics in the future[4].

Market Trends and Future Directions

Increasing Awareness and Incidence of Cancer

The rising incidence of cancer globally, particularly in regions like North America and Asia-Pacific, is a key trend driving the RYDAPT market. Increased awareness and the need for effective treatments are expected to continue driving demand for RYDAPT and similar targeted therapies[1][4].

Innovations in Cancer Treatment

Advancements in cancer treatment, including the development of targeted therapies and combination treatments, are expected to shape the future of the RYDAPT market. Clinical trials and research focusing on improving treatment outcomes and reducing side effects will be crucial for sustained market growth[2].

"RYDAPT is a medication that can be used for treating many categories of cancer and is not limited to only one type of leukemia. The versatility of this drug is increasing its demand all over the world."[1]

Key Takeaways

• The global RYDAPT market is projected to reach USD 2619.01 million by 2031, with a CAGR of 21.4%.
• The market is driven by the drug's efficacy in treating various types of cancer, including AML and mastocytosis-related conditions.
• North America is expected to dominate the market due to the high incidence of leukemia in the region.
• Novartis is the sole leading company in the global RYDAPT market.
• Adverse reactions are a significant restraining factor, but ongoing research aims to mitigate these effects.

FAQs

What is the expected market size of RYDAPT by 2031?

The global RYDAPT market is projected to touch USD 2619.01 million by 2031[1].

What is the CAGR of the RYDAPT market?

The RYDAPT market is expected to exhibit a CAGR of 21.4% by 2031[1].

Which segment is expected to lead the RYDAPT market?

The AML segment is anticipated to lead the market during the forecast period[1].

What are the primary driving factors for the RYDAPT market?

The primary driving factors include the drug's ability to increase patient lifespan, its versatility in treating various cancers, and FDA approval[1].

Which company is the leading player in the RYDAPT market?

Novartis is the sole leading company in the global RYDAPT market[1][4].

What are the common side effects associated with RYDAPT?

Common side effects include febrile neutropenia, nausea, mucositis, vomiting, and QT prolongation[2].

Sources

1. Business Research Insights: Rydapt Market Size, Segments & Global Analysis [2031]
2. Novartis: RYDAPT®
3. DataHorizzon Research: Rydapt Market Size, Share & Forecast 2033
4. HTF Market Intelligence: Rydapt Market Analysis by Relevant Business Segment & Application
5. McKesson Specialty Health: RYDAPT Approved for the Treatment of FLT3 Acute Myeloid Leukemia

Last updated: 2024-12-16