AIM ImmunoTech Granted U.S. Patent Covering Methods of Manufacturing Therapeutic dsRNA, Including Ampligen®
- New patent extends manufacturing protection for Ampligen until 2041, providing long-term market exclusivity
- Comprehensive patent portfolio covers manufacture, composition, and therapeutic applications of Ampligen
- Multiple Orphan Drug Designations from FDA and EMA provide additional 7-10 years of market exclusivity after approval
- Broad therapeutic potential across multiple high-value indications including cancer, viral diseases, and immune disorders
- FDA approval still pending for Ampligen across various indications
- Long development timeline required for multiple therapeutic applications
Insights
AIM secures manufacturing patent for Ampligen until 2041, completing comprehensive IP protection strategy.
AIM ImmunoTech has secured a critical U.S. patent (No. 12312376) covering manufacturing methods for therapeutic double-stranded RNA (dsRNA), including their flagship drug Ampligen. This patent extends protection until January 2041, providing nearly 16 years of manufacturing exclusivity from now.
This patent grant represents the final piece in AIM's strategic intellectual property portfolio. The company now holds three layers of protection: manufacturing methods (until 2041), drug composition, and therapeutic applications for specific conditions including cancer (until 2039), post-COVID fatigue (until 2042), and endometriosis (until 2040).
What makes this particularly valuable is how it complements AIM's multiple Orphan Drug Designations from both FDA and EMA. These designations provide additional market exclusivity after potential commercial approval - 7 years in the US and 10 years in Europe - for serious conditions including metastatic melanoma, renal cell carcinoma, pancreatic cancer, Ebola, chronic fatigue syndrome, and HIV.
For a biopharmaceutical company developing a complex product with multiple potential indications, this extended protection timeline provides crucial runway to navigate the regulatory approval process without immediate competitive pressure. While patent protection doesn't guarantee regulatory success, it significantly reduces long-term competitive risk if approvals are obtained.
This strategic IP milestone demonstrates management's focus on maximizing Ampligen's long-term commercial potential across multiple therapeutic areas where the drug has shown activity in clinical trials.
Patent portfolio now includes protection for manufacture, methods and compositions
Provides AIM with patent protection for manufacturing Ampligen until 2041
OCALA, Fla., June 12, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (OTC Pink: AIMID) (“AIM” or the “Company”) today announced the United States Patent and Trademark Office has granted U.S. patent No. 12312376, titled “Therapeutic Double Stranded RNA and Methods for Producing the Same.” The patent expires January 25, 2041.
The new patent covers methods involving the manufacture of a range of therapeutic double-stranded RNA (dsRNA) products, of which Ampligen is included. Combined with AIM’s multiple compositions and methods patents involving Ampligen, this manufacturing patent, along with AIM’s other issued patents, further secures the Company’s control over the synthesis and use of the first-in-class drug, and provides patent protection for manufacturing until 2041.
The new patent significantly extends the potential development runway for the drug, securing AIM additional time to safely and confidently develop its drug program as it seeks U.S. Food and Drug Administration (“FDA”) approval for Ampligen in any of a series of indications. Ampligen has demonstrated broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
AIM’s overall intellectual property portfolio covers the manufacture and use of Ampligen. AIM’s patents include Ampligen in the treatment of cancer (U.S. patent 11,813,279, expires August 9, 2039), the Post-COVID condition of fatigue (Netherlands’ patent 2032813, expires August 21, 2042) and endometriosis (U.S. patent 12,102,649, expires October 22, 2040).
AIM CEO Thomas K. Equels commented, “This patent is a significant milestone for AIM as it represents the final step in a multi-year project to strengthen and secure our global patent portfolio surrounding Ampligen. AIM now has extended patent protection for the manufacture of Ampligen, the composition of Ampligen and the way in which Ampligen can be utilized as a therapeutic for a diverse collection of unmet medical needs, from deadly cancers to Post-COVID conditions to endometriosis.”
Significantly, AIM’s intellectual property protection for Ampligen also includes multiple Orphan Drug Designations (“ODD”) from the FDA and the European Medicines Agency (“EMA”). FDA designation grants seven years of market exclusivity after commercial approval and EMA designation grants 10 years of market exclusivity after such approval. AIM’s orphan drug designations include Metastatic Melanoma (US), Renal Cell Carcinoma (US), Pancreatic Adenocarcinoma (US and EU), Ebola Virus Disease (US and EU), Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (US) and HIV (US).
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.
Cautionary Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a prophylactic or therapy for any indication. The granting of patents and Orphan Medicinal Production Designation, while beneficial, do not assure commercial approval. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com
FAQ
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