SONIDEGIB PHOSPHATE - Generic Drug Details

What are the generic sources for sonidegib phosphate and what is the scope of patent protection?

Sonidegib phosphate is the generic ingredient in one branded drug marketed by Sun Pharm and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sonidegib phosphate has one hundred and eighteen patent family members in forty-nine countries.

There is one drug master file entry for sonidegib phosphate. One supplier is listed for this compound.

Summary for SONIDEGIB PHOSPHATE

International Patents:	118
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	2
Patent Applications:	72
DailyMed Link:	SONIDEGIB PHOSPHATE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,266,523

Dosage:

CAPSULE;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.

Recent Clinical Trials for SONIDEGIB PHOSPHATE

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

Sponsor	Phase
Senhwa Biosciences, Inc.	Phase 1
Novartis Pharmaceuticals	Phase 2
National Cancer Institute (NCI)	Phase 2

See all SONIDEGIB PHOSPHATE clinical trials

Pharmacology for SONIDEGIB PHOSPHATE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SONIDEGIB PHOSPHATE

L01XJ	Hedgehog pathway inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for SONIDEGIB PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes	8,063,043		Y	Y
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes	10,266,523		Y	Y
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes	8,178,563			Y

International Patents for SONIDEGIB PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016155630
Hong Kong	1127043	COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS
Georgia, Republic of	P20125592	SALTS OF N-[6-(CIS-2,6-DIMETHYLMORPHOLIN-4-YL)- PYRIDINE-3-YL]-2-METHYL-4'- (TRIFLUOROMETHOXY)[1,1'- BIPHENYL]-3-CARBOXAMIDE
El Salvador	2011003857	SALES N-[6-(CIS-2,6-DIMETIL-MORFOLIN-4-IL)- PIRIDIN-3-IL]-2-METIL-4'-(TRIFLUORO-METOXI)-[1,1'-BIFENIL]-3-CARBOXAMIDA.
Israel	194818	תרכובות ותכשירים כמאפננים של שביל קיפוד (Compounds and compositions as hedgehog pathway modulators)

Supplementary Protection Certificates for SONIDEGIB PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	1590062-4	Sweden		PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/15/1030 20150818
2021328	658	Finland
2021328	PA2015051	Lithuania		PRODUCT NAME: SONIDEGIBUM; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328	64/2015	Austria		PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/15/1030 (MITTEILUNG) 20150818
2021328	92883	Luxembourg		PRODUCT NAME: SONIDEGIB OU UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; FIRST REGISTRATION: 20150818

SONIDEGIB PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sonidegib Phosphate

Introduction

Sonidegib phosphate, marketed under the trade name Odomzo, is a Hedgehog pathway inhibitor developed by Novartis for the treatment of various types of cancer, most notably basal cell carcinoma (BCC). Here, we delve into the market dynamics and financial trajectory of this drug.

Current Market Indications

Sonidegib phosphate is primarily indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or in cases where patients are not candidates for these treatments[4].

Clinical Development and Expansion

Beyond its primary indication, sonidegib phosphate is under clinical development for several other types of cancer. For instance, Sun Pharma Advanced Research is currently conducting Phase I trials for its use in non-small cell lung cancer (NSCLC)[2].

Market Authorization and Regulatory Approvals

Sonidegib phosphate has received regulatory approvals in several countries. In Canada, Health Canada issued a Notice of Compliance (NOC) for Odomzo in June 2020, based on efficacy and safety data from clinical trials[3]. Similarly, the FDA approved Odomzo in 2015 for the treatment of locally advanced BCC[4].

Financial Performance and Projections

The financial performance of sonidegib phosphate has been significant, particularly given its niche market. Sales of Odomzo are expected to peak at $653 million USD by 2024, indicating a strong market presence[1].

Competitive Landscape

The competitive landscape for Hedgehog pathway inhibitors is relatively specialized, with sonidegib phosphate being one of the key players. However, the expansion into new indications, such as NSCLC, could introduce new competitors and alter market dynamics[2].

Clinical Trials and Phase Transition Success Rates

The Phase I trials for sonidegib phosphate in NSCLC have an 80% phase transition success rate (PTSR) benchmark for progressing into Phase II, according to GlobalData. This indicates a promising outlook for the drug's potential expansion into new markets[2].

Economic Impact of Sustainable Synthesis

The development of a more sustainable synthesis route for sonidegib phosphate, using aqueous micellar conditions and low levels of palladium catalyst, is expected to reduce production costs and environmental impact. This could enhance the drug's economic viability and contribute to its financial trajectory[1].

Patient and Market Response

Clinical trials have shown that sonidegib phosphate has a favorable benefit-harm-uncertainty profile. For example, in the BOLT trial, the objective response rate was 47% at 6 months and 56% at 42 months, with a median duration of response of 26.1 months. This positive response from both patients and clinicians supports the drug's market position[3].

Adverse Reactions and Safety Profile

While sonidegib phosphate has shown efficacy, it also comes with a range of adverse reactions, including musculoskeletal pain, muscle spasms, and elevated serum creatine kinase levels. Managing these side effects is crucial for maintaining patient compliance and market acceptance[4].

Pharmacokinetics and Drug Interactions

The drug's pharmacokinetics, including its high bioavailability when taken with food and extensive distribution in the body, influence its dosing regimen. Understanding these dynamics is essential for optimizing treatment outcomes and minimizing adverse effects[3].

Future Development and Pipeline

Sun Pharma Advanced Research's ongoing development of sonidegib phosphate for various cancers, along with other therapeutic focuses, indicates a robust pipeline. This continuous innovation is likely to sustain the drug's market presence and financial growth[2].

Key Takeaways

• Market Indications: Primarily for locally advanced BCC, with ongoing trials for NSCLC and other cancers.
• Financial Projections: Expected to peak at $653 million USD by 2024.
• Regulatory Approvals: Approved by FDA and Health Canada.
• Sustainable Synthesis: New synthesis methods reduce costs and environmental impact.
• Clinical Response: Favorable benefit-harm-uncertainty profile with significant response rates.
• Adverse Reactions: Musculoskeletal pain, muscle spasms, and elevated serum CK levels are common.
• Future Development: Ongoing trials for new indications and continuous pipeline innovation.

FAQs

Q: What is the primary indication for sonidegib phosphate?

A: The primary indication for sonidegib phosphate (Odomzo) is the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or in cases where patients are not candidates for these treatments[4].

Q: What are the ongoing clinical developments for sonidegib phosphate?

A: Sonidegib phosphate is currently under clinical development for the treatment of non-small cell lung cancer (NSCLC) and other types of cancer, such as adenocarcinoma of the gastroesophageal junction and medulloblastoma[2].

Q: What are the expected sales projections for sonidegib phosphate?

A: Sales of Odomzo are expected to peak at $653 million USD by 2024[1].

Q: How does the new synthesis method impact the production of sonidegib phosphate?

A: The new synthesis method uses aqueous micellar conditions and low levels of palladium catalyst, reducing production costs and environmental impact[1].

Q: What are the common adverse reactions associated with sonidegib phosphate?

A: Common adverse reactions include musculoskeletal pain, muscle spasms, and elevated serum creatine kinase levels[4].

Cited Sources

1. An Environmentally Responsible 3-pot, 5-step Synthesis of the Anticancer Drug Sonidegib - Royal Society of Chemistry.
2. Sonidegib phosphate by Sun Pharma Advanced Research for Non-Small Cell Lung Cancer - Pharmaceutical Technology.
3. Summary Basis of Decision for Odomzo - Health Canada.
4. ODOMZO (sonidegib) - FDA Medical Review - FDA.