DUVYZAT Drug Patent Profile

Which patents cover Duvyzat, and when can generic versions of Duvyzat launch?

Duvyzat is a drug marketed by Italfarmaco Spa and is included in one NDA. There are four patents protecting this drug.

This drug has fifty-nine patent family members in thirty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Duvyzat

Duvyzat will be eligible for patent challenges on March 21, 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 March 21, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DUVYZAT

International Patents:	59
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in DUVYZAT?	DUVYZAT excipients list
DailyMed Link:	DUVYZAT at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER

NDA:

217865

Dosage:

SUSPENSION;ORAL

^*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 DUVYZAT

DUVYZAT is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER.

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
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes	9,421,184
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes	7,329,689		Y	Y
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes	9,867,799
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes	10,688,047		Y

International Patents for DUVYZAT

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1200731	用於治療肌肉萎縮症的二乙基- -羥基氨基甲酰基-苯基-氨基甲酰氧基-甲基 -萘- -基-甲基 -氯化銨 (DIETHYL- [6- (4-HYDROXYCARBAMOYL-PHENYL-CARBAMOYLOXY-METHYL) - NAPHTHALEN-2-YL-METHYL] -AMMONIUM CHLORIDE FOR USE IN THE TREATMENT OF MUSCULAR DYSTROPHY -[6-(4---- )--2--]-)
Japan	2006515028
Japan	2015512869	筋ジストロフィーの治療に用いられるジエチル−［６−（４−ヒドロキシカルバモイル−フェニル−カルバモイルオキシ−メチル）−ナフタレン−２−イル−メチル］−アンモニウムクロリド
San Marino	T202100161

Market Dynamics and Financial Trajectory for DUVYZAT

Introduction to DUVYZAT

DUVYZAT, also known as givinostat, is a groundbreaking drug approved by the FDA in March 2024 for the treatment of Duchenne muscular dystrophy (DMD). Developed by Italfarmaco and marketed in the U.S. by its subsidiary ITF Therapeutics, DUVYZAT is the first non-steroidal, oral treatment for DMD, marking a significant milestone in the treatment landscape for this debilitating disease[1][2][4].

Market Need and Demand

Duchenne muscular dystrophy is a progressive and typically fatal neuromuscular disease, affecting primarily boys and young men. The lack of effective treatments has long been a critical issue, making the approval of DUVYZAT a highly anticipated event. The drug's ability to slow inflammation and muscle loss, regardless of the patient's genetic mutation, fills a significant gap in the treatment options available for DMD patients[1][2].

Competitive Landscape

The treatment landscape for DMD has evolved significantly in recent years. Prior to DUVYZAT, treatments were largely limited to steroids, exon skippers, and more recently, gene therapies like Elevidys from Sarepta Therapeutics. However, these treatments are often restricted to specific subsets of patients based on their genetic mutations or disease stage. DUVYZAT's broad applicability sets it apart, making it a valuable addition to the treatment arsenal[1].

Clinical Efficacy and Safety

DUVYZAT has demonstrated statistically significant benefits in clinical trials, particularly in measures of motor function. The drug works by inhibiting histone deacetylase (HDAC) overactivity, which contributes to muscle damage in DMD. When used in combination with steroids, DUVYZAT showed improved outcomes in patients' ability to climb stairs and overall functional scales[1][4].

However, the drug is not without side effects. Common adverse reactions include diarrhea, stomach pain, nausea, and vomiting. More serious side effects, such as thrombocytopenia (low platelet count), have also been observed, necessitating careful monitoring of patients' platelet counts and triglyceride levels[1][5].

Market Approval and Availability

Following FDA approval, ITF Therapeutics announced that DUVYZAT would be available in the U.S. as of July 25, 2024. Additionally, Italfarmaco's Marketing Authorization Application (MAA) for givinostat has been validated by the European Medicines Agency (EMA), paving the way for potential approval and availability in the European Union[2].

Financial Implications and Pricing

The pricing of DUVYZAT has not been determined yet, according to an ITF Therapeutics spokesperson. However, given its unique position in the market and the significant unmet need it addresses, the drug is likely to command a premium price. The financial trajectory of DUVYZAT will be influenced by its adoption rate, reimbursement policies, and the overall market demand for effective DMD treatments[1].

Market Growth and Projections

The approval of DUVYZAT aligns with broader trends in the pharmaceutical industry, particularly the growing focus on targeted therapies and personalized medicine. The global small molecule drug discovery market, which includes drugs like DUVYZAT, is projected to grow from $40.2 billion in 2023 to $58.4 billion by 2030, at a CAGR of 5.5%[3].

Patient Advocacy and Community Impact

Patient advocacy groups, such as CureDuchenne, have welcomed the approval of DUVYZAT as a significant step forward in treating DMD. Debra Miller, the founder and CEO of CureDuchenne, highlighted the drug's potential to accelerate transformative treatments for all DMD patients, regardless of their genetic mutation[1].

Research and Development Continuum

The development of DUVYZAT is a testament to decades of dedication by scientists and researchers. Pier Lorenzo Puri, a key researcher involved in the drug's development, emphasized the ongoing work to synergize gene therapy and HDAC inhibitors without the need for steroids, indicating a continued pipeline of innovative treatments for DMD[2].

Key Takeaways

• Broad Applicability: DUVYZAT is the first non-steroidal treatment approved for all DMD patients aged six and above, regardless of genetic mutation.
• Clinical Efficacy: The drug has shown significant benefits in motor function and slowing disease progression.
• Safety Monitoring: Requires careful monitoring of platelet counts and triglyceride levels due to potential side effects.
• Market Availability: Available in the U.S. as of July 25, 2024, with potential approval in the EU.
• Financial Trajectory: Pricing yet to be determined, but expected to be premium due to its unique market position.
• Market Growth: Part of a growing small molecule drug discovery market projected to reach $58.4 billion by 2030.

FAQs

1. What is DUVYZAT and how does it work?

   • DUVYZAT (givinostat) is an HDAC inhibitor that works by blocking HDAC overactivity, which leads to muscle damage in Duchenne muscular dystrophy, thereby slowing the breakdown of muscle fibers.

2. Who is eligible for DUVYZAT treatment?

   • DUVYZAT is approved for use in all DMD patients who are at least six years old, regardless of their genetic mutation.

3. What are the common side effects of DUVYZAT?

   • Common side effects include diarrhea, stomach pain, nausea, and vomiting. More serious side effects can include thrombocytopenia (low platelet count).

4. How does DUVYZAT compare to other DMD treatments?

   • Unlike other treatments that are often restricted to specific subsets of patients, DUVYZAT is broadly applicable and can be used in combination with steroids to enhance treatment outcomes.

5. What is the current status of DUVYZAT's availability?

   • DUVYZAT is available in the U.S. as of July 25, 2024, and is under review by the European Medicines Agency (EMA) for potential approval in the EU.

Cited Sources

1. FDA clears first-of-its-kind Duchenne drug for broad use - BioPharma Dive
2. Decades of dedication led to FDA approval of a new treatment for Duchenne muscular dystrophy - Sanford Burnham Prebys
3. Small Molecule Drug Discovery Market Research Report 2024-2030 - GlobeNewswire
4. Muscular Dystrophy Association's Funding of Foundational Research Leads to New FDA-Approved Treatment DUVYZAT (Givinostat) for Duchenne Muscular Dystrophy - BioSpace
5. 217865Orig1s000 OTHER REVIEW(S) - FDA.gov