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ODOMZO Drug Patent Profile

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

Odomzo is a drug marketed by Sun Pharm and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and eighteen patent family members in forty-nine countries.

The generic ingredient in ODOMZO is sonidegib phosphate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sonidegib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Odomzo

Odomzo was eligible for patent challenges on July 24, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ODOMZO

International Patents:	118
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	6
Patent Applications:	583
Drug Prices:	Drug price information for ODOMZO
What excipients (inactive ingredients) are in ODOMZO?	ODOMZO excipients list
DailyMed Link:	ODOMZO at DailyMed

See drug prices for ODOMZO

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

NDA:

205266

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 ODOMZO

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

Sponsor	Phase
Gruppo Oncologico del Nord-Ovest	Phase 2
Melanoma Institute Australia	Phase 2
Anne Chang	Phase 2

See all ODOMZO clinical trials

Pharmacology for ODOMZO

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

US Patents and Regulatory Information for ODOMZO

ODOMZO is protected by three US patents.

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
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes				Y
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes			Y	Y
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes			Y	Y

International Patents for ODOMZO

When does loss-of-exclusivity occur for ODOMZO?

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

China

European Patent Office

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 ODOMZO around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	2018021
Nicaragua	201100051	SALES DE N - [ 6 - ( CIS - 2, 6 - DIMETIL - MORFOLIN - 4 - IL ) - PIRIDIN - 3 - IL ] - 2 - METIL - 4' - ( TRIFLUORO - METOXI ) - [ 1, 1' - BIFENIL] - 3 - CARBOXAMIDA.
Costa Rica	10399	COMPUESTOS Y COMPOSICIONES COMO MODULADORES DE LA SENDA DE HEDGEHOG
South Korea	20080108343	COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS
Tunisia	SN08437	COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS
Denmark	2342198
Cyprus	1114471

Supplementary Protection Certificates for ODOMZO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021328	PA2015051,C2021328	Lithuania		PRODUCT NAME: SONIDEGIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, HIDRATAS ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/15/1030 20150818
2021328	300790	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2021328	122016000001	Germany		PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1030 20150814
2021328	2015/055	Ireland		PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTRATION NO/DATE: EU/1/15/1030(C(2015)5890 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	CA 2015 00057	Denmark		PRODUCT NAME: SONIDEGIB ELLER ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER SONIDEGIBFOSFAT; REG. NO/DATE: EU/1/15/1030 20150818
2021328	255 5026-2015	Slovakia		FORMER OWNER: NOVARTIS AG, CH

ODOMZO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ODOMZO

Introduction to ODOMZO

ODOMZO, also known as sonidegib, is a cancer medication that targets the hedgehog signaling pathway, a critical pathway in cell development that, when mutated, can lead to cancer. It is primarily used to treat adults with locally advanced basal cell carcinoma (laBCC), a type of skin cancer that has started to spread nearby but not to other parts of the body[4].

Market Size and Growth

The hedgehog pathway inhibitors market, which includes ODOMZO, has been experiencing significant growth. As of 2021, the global hedgehog pathway inhibitors market was valued at USD 531.39 million and is expected to reach USD 840.58 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 5.90% during the forecast period of 2022 to 2029[1].

Drivers of Market Growth

Several factors are driving the growth of the market for hedgehog pathway inhibitors like ODOMZO:

Increasing Prevalence of Basal Cell Carcinoma

The rising prevalence of basal cell carcinoma is a major driver. According to the American Cancer Society, 5.4 million people worldwide are diagnosed with squamous and basal cell skin cancer each year, with basal cell carcinoma being the most common type. This increasing incidence is expected to boost the demand for ODOMZO and other hedgehog pathway inhibitors[1].

Preference Over Conventional Treatments

Patients and healthcare providers are increasingly preferring hedgehog pathway inhibitors over conventional cancer treatments due to their effectiveness and the potential for less painful treatment. This preference is further fueling the market growth[1].

Healthcare Infrastructure Investment

The increasing investment in healthcare infrastructure is another significant factor. Improved healthcare facilities and better access to advanced treatments are enhancing the market for these inhibitors[1].

Acquisition and Ownership

In 2016, Sun Pharma acquired ODOMZO from Novartis for $175 million, along with potential milestone payments. This acquisition was part of Sun Pharma's strategy to expand its oncology portfolio, particularly in the branded dermatology segment[3].

Financial Performance

When Novartis owned ODOMZO, the drug generated less than $21 million in revenue during the third quarter of 2016. Despite this relatively low revenue, the acquisition by Sun Pharma was seen as a strategic move to bolster its oncology offerings. Sun Pharma's financials indicated a strong cash position and increasing gross sales, which supported the acquisition and further development of ODOMZO[3].

Clinical Efficacy and Approval

ODOMZO was approved by the FDA in mid-2015 for the treatment of locally advanced basal cell carcinoma in patients whose cancer had returned after surgery or radiation or who were not candidates for these treatments. Clinical trials showed that around 56% of patients on the 200-mg dose and 45% on the 800-mg dose responded to treatment, indicating its efficacy in reducing tumor size and improving other signs of cancer[4].

Pricing and Access

To make ODOMZO more accessible, Sun Pharma offers various financial assistance programs. Patients with commercial health insurance can pay as little as $10 per month for ODOMZO through these programs. Additionally, there is a Patient Assistance Program available for those who need further financial support[2].

Distribution Channels

ODOMZO is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. This diverse distribution network helps ensure that the drug is readily available to patients across different healthcare settings[1].

Competitive Landscape

The market for hedgehog pathway inhibitors is competitive, with other drugs like Erivedge and Daurismo also playing significant roles. However, ODOMZO's specific approval for locally advanced basal cell carcinoma and its clinical efficacy make it a key player in this segment[1].

Future Outlook

Given the increasing prevalence of basal cell carcinoma and the preference for targeted therapies, the demand for ODOMZO is expected to continue growing. Sun Pharma's ongoing efforts to expand its oncology portfolio and improve access to the drug through financial assistance programs will likely contribute to its financial trajectory.

Key Takeaways

• Market Growth: The hedgehog pathway inhibitors market, including ODOMZO, is expected to grow at a CAGR of 5.90% from 2022 to 2029.
• Clinical Efficacy: ODOMZO has shown significant efficacy in treating locally advanced basal cell carcinoma.
• Financial Assistance: Various programs are available to make ODOMZO more affordable for patients.
• Distribution: The drug is distributed through multiple channels, ensuring wide availability.
• Acquisition: Sun Pharma acquired ODOMZO from Novartis in 2016 to expand its oncology offerings.

FAQs

1. What is ODOMZO used for? ODOMZO is used to treat adults with locally advanced basal cell carcinoma, a type of skin cancer that has started to spread nearby but not to other parts of the body[4].

2. Who acquired ODOMZO from Novartis? Sun Pharma acquired ODOMZO from Novartis in 2016 for $175 million, along with potential milestone payments[3].

3. What is the expected market size of hedgehog pathway inhibitors by 2029? The global hedgehog pathway inhibitors market is expected to reach USD 840.58 million by 2029[1].

4. How effective is ODOMZO in treating basal cell carcinoma? Clinical trials showed that around 56% of patients on the 200-mg dose and 45% on the 800-mg dose responded to treatment, indicating its efficacy in reducing tumor size and improving other signs of cancer[4].

5. What financial assistance programs are available for ODOMZO? Patients with commercial health insurance can pay as little as $10 per month for ODOMZO through various financial assistance programs, including the Patient Assistance Program[2].

Cited Sources:

1. Data Bridge Market Research - Global Hedgehog Pathway Inhibitors Market – Industry Trends and Forecast to 2029.
2. ODOMZO - Start saving on ODOMZO.
3. BioPharma Dive - Novartis, Sun Pharma enter deal for oncology drug Odomzo.
4. European Medicines Agency (EMA) - Odomzo.