QUTENZA Drug Patent Profile

When do Qutenza patents expire, and when can generic versions of Qutenza launch?

Qutenza is a drug marketed by Averitas and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in QUTENZA is capsaicin. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the capsaicin profile page.

DrugPatentWatch^® Generic Entry Outlook for Qutenza

Qutenza was eligible for patent challenges on November 16, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 26, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for QUTENZA

International Patents:	67
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	27
Drug Prices:	Drug price information for QUTENZA
What excipients (inactive ingredients) are in QUTENZA?	QUTENZA excipients list
DailyMed Link:	QUTENZA at DailyMed

See drug prices for QUTENZA

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

Constraining patent/regulatory exclusivity:

8,821,920

NDA:

022395

Dosage:

PATCH;TOPICAL

^*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 QUTENZA

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

Sponsor	Phase
Nantes University Hospital	Phase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	N/A
Leiden University Medical Center	N/A

See all QUTENZA clinical trials

US Patents and Regulatory Information for QUTENZA

QUTENZA is protected by three US patents.

This potential generic entry date is based on patent 8,821,920.

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
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes	9,226,903		Y
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes	10,034,841		Y
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes	8,821,920		Y

Expired US Patents for QUTENZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009	6,239,180
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009	10,463,598
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009	8,263,059
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009	10,869,827

EU/EMA Drug Approvals for QUTENZA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Grunenthal GmbH	Qutenza	capsaicin	EMEA/H/C/000909 Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.	Authorised	no	no	no	2009-05-15

International Patents for QUTENZA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1791533
Canada	2497771	COMPOSITIONS ET KITS POUR L'ELIMINATION DE COMPOSES IRRITANTS DE SURFACES CORPORELLES (COMPOSITIONS AND KITS FOR THE REMOVAL OF IRRITATING COMPOUNDS FROM BODILY SURFACES)
Poland	2529732
Eurasian Patent Organization	012367	КОМПОЗИЦИЯ И СПОСОБ ОЧИСТКИ ПОВЕРХНОСТИ ТЕЛА ОТ КАПСАИЦИНА, НАБОР И СПОСОБ ЛЕЧЕНИЯ БОЛИ (COMPOSITION AND METHOD FOR REMOVAL CAPSAICIN FROM BODILY SURFACE, A KIT THEREFOR AND METHOD FOR TREATING PAIN)

Market Dynamics and Financial Trajectory for Qutenza

Introduction to Qutenza

Qutenza, a topical, non-systemic, non-opioid pain treatment, has been a significant player in the management of neuropathic pain. Developed by Grünenthal and marketed in the U.S. by its subsidiary Averitas Pharma, Inc., Qutenza has seen substantial growth and expansion in its indications.

Market Size and Growth

The U.S. diabetic neuropathy market, in which Qutenza is a key player, is projected to grow significantly. By 2030, the market is expected to be valued at US$ 2,635.9 million, with a Compound Annual Growth Rate (CAGR) of 5.2% from 2022 to 2030[1].

Key Indications and Approvals

Qutenza has received several critical approvals that have driven its market growth. It was initially approved for treating neuropathic pain associated with postherpetic neuralgia. In 2020, the U.S. Food and Drug Administration (FDA) granted approval for Qutenza to treat neuropathic pain related to diabetic peripheral neuropathy (DPN) of the feet in adults[1][4].

Ongoing Clinical Trials and Future Indications

Averitas Pharma has completed patient recruitment for the Phase III AV001 clinical study, which is assessing Qutenza for the treatment of post-surgical neuropathic pain (PSNP). This trial, if successful, could lead to an expanded indication for Qutenza in the U.S. market, further boosting its market presence[3].

Financial Performance of Grünenthal

Grünenthal, the parent company of Averitas Pharma, has reported strong financial results. In 2023, Grünenthal generated €1.8 billion in revenues, a 10% increase over the prior year. The adjusted EBITDA was €427 million, although it decreased by 3% due to increased investments in Research & Development (R&D), acquisitions, and modernizing production facilities[2][5].

Regional Performance

Grünenthal's strong business performance in the United States, Latin America, and Europe has been a significant factor in its revenue growth. Qutenza, in particular, has seen increased demand in the U.S., where it is indicated for treating postherpetic neuralgia and pain related to diabetic neuropathy of the feet[2].

Competitive Landscape

The neuropathic pain market is competitive, with several major pharmaceutical companies involved. Key players include Novartis AG, Teva Pharmaceuticals, Abbott Laboratories, and Pfizer Inc., among others. However, Qutenza's unique position as a topical, non-systemic, non-opioid treatment sets it apart in the market[4].

Distribution Channels

The distribution of Qutenza is primarily through drug stores and retail pharmacies, which dominated the market in 2022. However, the online pharmacies segment is expected to grow at a higher CAGR due to convenience, improvements in logistics, and ease of payment options[4].

Strategic Investments

Grünenthal has invested significantly in R&D, with over €1 billion spent since 2017. This investment has advanced its R&D pipeline, including the development of Qutenza for new indications. The company has also acquired established brands and grown its presence in key pharmaceutical markets like the United States[2].

CEO Insights

Gabriel Baertschi, CEO and Chairman of the Corporate Executive Board of Grünenthal, highlighted the company's consistent growth strategy and significant investments in R&D. He emphasized that these efforts are aimed at developing innovative solutions for pain management, aligning with the company's vision of a "World Free of Pain"[2].

Patient Impact

Qutenza has advanced the treatment trajectory for patients with neuropathic pain, particularly those with diabetic peripheral neuropathy and postherpetic neuralgia. The treatment provides up to three months of relief from nerve pain with a single local topical application, significantly improving the quality of life for these patients[1][3].

Future Outlook

Given the positive trial data and the potential for expanded indications, Qutenza is poised for continued growth. The submission of a supplemental new drug application (sNDA) in 2026 for the treatment of post-surgical neuropathic pain could further enhance its market position[3].

Key Takeaways

• Market Growth: The U.S. diabetic neuropathy market, driven by Qutenza, is expected to reach US$ 2,635.9 million by 2030.
• Approvals and Indications: Qutenza has received FDA approvals for treating neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.
• Clinical Trials: Ongoing Phase III trials for post-surgical neuropathic pain could lead to expanded indications.
• Financial Performance: Grünenthal's revenue and adjusted EBITDA have shown significant growth, driven by strong performance in the U.S. and other regions.
• Strategic Investments: Substantial investments in R&D and acquisitions have positioned Grünenthal for continued growth.

FAQs

Q: What is Qutenza used for?

A: Qutenza is used for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet and postherpetic neuralgia.

Q: Who is the manufacturer of Qutenza?

A: Qutenza is developed by Grünenthal and marketed in the U.S. by its subsidiary Averitas Pharma, Inc.

Q: What is the unique feature of Qutenza?

A: Qutenza is a topical, non-systemic, non-opioid pain treatment that delivers prescription-strength capsaicin directly into the skin.

Q: What are the ongoing clinical trials for Qutenza?

A: Averitas Pharma is conducting a Phase III clinical trial to assess Qutenza for the treatment of post-surgical neuropathic pain.

Q: How has Grünenthal's financial performance been in recent years?

A: Grünenthal has reported record revenues and adjusted EBITDA, with a 10% increase in revenues in 2023 compared to the prior year.

Sources

1. Coherent Market Insights: U.S. Diabetic Neuropathy Market Size and Forecast to 2030.
2. Grünenthal: 2023 full-year results.
3. Clinical Trials Arena: Averitas completes recruitment for trial of QUTENZA to treat PSNP.
4. Allied Market Research: Neuropathic Pain Market Size, Share, Trends & Demand [2032].
5. The Pharma Letter: Grünenthal's revenue and earnings growth goes steadily on.

Last updated: 2024-12-16