Nutriband's AVERSA™ abuse-deterrent technology is patented in 46 markets, targeting FDA approval by mid-2025.
Quiver AI Summary
Nutriband Inc. has successfully patented its abuse-deterrent transdermal technology in 46 countries, including key markets like the U.S., Europe, and China. The company is planning to file for FDA approval for its lead product, AVERSA™ Fentanyl, in the first half of 2025. Recently, Nutriband extended its Chinese patent to Macao, further solidifying its international intellectual property rights. The AVERSA™ technology is designed to prevent the misuse and diversion of drugs with potential for abuse, such as opiates, while ensuring accessibility for patients in need. Partnering with Kindeva Drug Delivery, Nutriband aims to develop AVERSA™ Fentanyl, which could potentially generate peak annual sales between $80 million and $200 million.
Potential Positives
- Nutriband's AVERSA™ technology is now patented in 46 countries, enhancing its intellectual property portfolio and strengthening its market position globally.
- The company is targeting FDA approval for AVERSA™ Fentanyl in the first half of 2025, potentially facilitating entry into the lucrative U.S. opioid market.
- AVERSA™ Fentanyl has the potential to generate significant revenue, with projected peak annual U.S. sales estimated between $80 million to $200 million.
- The collaboration with Kindeva Drug Delivery, a recognized leader in drug-device combination products, bolsters Nutriband's development of a competitive product in the market.
Potential Negatives
- The company faces uncertainty and potential setbacks regarding regulatory approvals for their AVERSA™ Fentanyl product, as indicated by their targeted timeline for FDA filing in 2025.
- There are inherent risks associated with the development of their proposed products, including the potential inability to obtain necessary financing and regulatory approvals, which could significantly impact their business viability.
- The press release includes forward-looking statements that highlight numerous uncertainties, which could lead to actual results differing materially from company expectations, raising concerns for investors about the credibility of their projections.
FAQ
What is Nutriband's AVERSA™ technology?
Nutriband's AVERSA™ technology incorporates aversive agents into transdermal patches to prevent the abuse and misuse of drugs like opioids.
How many countries have granted patents for AVERSA™ technology?
AVERSA™ technology is patented in 46 countries and territories, covering major global markets including the United States and Europe.
When does Nutriband plan to file for FDA approval?
Nutriband is targeting to file for FDA approval for AVERSA™ Fentanyl in the first half of 2025.
What is the market potential for AVERSA™ Fentanyl?
AVERSA™ Fentanyl has the potential to achieve peak annual US sales of $80 million to $200 million.
How does AVERSA™ improve safety for transdermal drugs?
AVERSA™ improves safety by deterring abuse while ensuring access for patients who genuinely need these medications.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Nutriband’s abuse-deterrent platform technology is now patented in 46 countries and territories covering major global markets.
Nutriband is targeting to file for FDA approval for AVERSA™ Fentanyl in the first half of 2025.
ORLANDO, Fla., Dec. 27, 2024 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has completed the registration requirements to extend its Chinese patent to Macao for its patent entitled, “Abuse and Misuse Deterrent Transdermal Systems,” which protects its AVERSA™ abuse deterrent transdermal technology.
The Macao IP Office has assigned number J/9010 to the patent with an entry date of December 17, 2024. Macao is a Special Administrative Region (SAR) of the People’s Republic of China which affords it a high degree of autonomy with its own patent system and patent laws which are separate and distinct from those of mainland China.
The Aversa™ abuse deterrent technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia as well as two regions of China: Hong Kong and Macao.
Nutriband’s AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse while making sure that these drugs remain accessible to those patients who really need them.
Nutriband is currently working with its partner Kindeva Drug Delivery (formerly 3M drug delivery systems), a leading global contract development and manufacturing organization focused on drug-device combination products, to develop its lead product, AVERSA™ Fentanyl, which incorporates Nutriband’s AVERSA™ abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system.
AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.
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Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband's AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company's website is
www.nutriband.com
. Any material contained in or derived from the Company's websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words "believes," "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
Contact Information
:
Investor Relations
RedChip Companies, Inc.
Dave Gentry
Email: NTRB@Redchip.com
Phone: 1-800-RED-CHIP (733-2447)
or 407-644-4256
Address:
431 E Horatio Ave, Suite #100
Maitland, FL 32751
Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com
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