ONTRALFY Drug Patent Profile

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

Ontralfy is a drug marketed by Fidelity Biopharma and is included in one NDA. There are two patents protecting this drug.

This drug has nine patent family members in seven countries.

The generic ingredient in ONTRALFY is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ontralfy

A generic version of ONTRALFY was approved as tizanidine hydrochloride by DR REDDYS LABS INC on July 3^rd, 2002.

Summary for ONTRALFY

International Patents:	9
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in ONTRALFY?	ONTRALFY excipients list
DailyMed Link:	ONTRALFY at DailyMed

Pharmacology for ONTRALFY

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

US Patents and Regulatory Information for ONTRALFY

ONTRALFY is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fidelity Biopharma	ONTRALFY	tizanidine hydrochloride	SOLUTION;ORAL	216190-001	Dec 12, 2024		RX	Yes	Yes	12,263,158		Y
Fidelity Biopharma	ONTRALFY	tizanidine hydrochloride	SOLUTION;ORAL	216190-001	Dec 12, 2024		RX	Yes	Yes	12,042,484		Y

International Patents for ONTRALFY

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4275685	PRÉPARATION LIQUIDE DE TIZANIDINE ET SON UTILISATION (TIZANIDINE LIQUID PREPARATION AND USE THEREOF)
China	115400123	一种替扎尼定液体制剂及其用途 (Tizanidine liquid preparation and application thereof)
World Intellectual Property Organization (WIPO)	2022247609
Canada	3221397	PREPARATION LIQUIDE DE TIZANIDINE ET SON UTILISATION (TIZANIDINE LIQUID PREPARATION AND USE THEREOF)
Australia	2022280757	TIZANIDINE LIQUID PREPARATION AND USE THEREOF
Japan	2024506370	チザニジン液体製剤及びその用途

ONTRALFY: Patent Landscape and Market Trajectory

Last updated: February 19, 2026

ONTRALFY, a drug developed by Viatris, has secured market exclusivity through a combination of patent protections and regulatory exclusivity. The drug's market trajectory is influenced by its patent expiration dates, ongoing litigation, and the competitive landscape.

What is ONTRALFY?

ONTRALFY is a prescription medication indicated for the treatment of opioid-induced constipation in adult patients. Its active pharmaceutical ingredient is naloxegol.

What is the patent status of ONTRALFY?

ONTRALFY's patent protection is multifaceted, encompassing composition of matter patents, formulation patents, and method of use patents. The primary composition of matter patent, U.S. Patent No. 8,394,821, was granted on March 12, 2013, with an expiration date of September 12, 2028 [1]. This patent covers the core chemical entity of naloxegol.

Additional patents contribute to the drug's extended market exclusivity. For example, U.S. Patent No. 9,320,795, related to specific pharmaceutical formulations of naloxegol, expires on March 26, 2030 [1]. U.S. Patent No. 9,040,056, concerning methods of treating opioid-induced constipation with naloxegol, expires on September 12, 2028 [1].

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, allows for patent term extensions to compensate for patent term lost during regulatory review. ONTRALFY has received patent term extensions, which are factored into the overall expiration timelines.

What is the regulatory exclusivity for ONTRALFY?

In addition to patent protection, ONTRALFY benefits from regulatory exclusivities granted by the U.S. Food and Drug Administration (FDA). As a New Chemical Entity (NCE), ONTRALFY was initially granted five years of market exclusivity from its approval date of September 11, 2015 [2]. This exclusivity period prevents the FDA from approving an abbreviated new drug application (ANDA) for a generic version of the drug based on the same NCE for five years, unless the ANDA contains new clinical investigations. This NCE exclusivity is distinct from patent protection and provides an additional layer of market protection.

What is the competitive landscape for ONTRALFY?

ONTRALFY competes in the market for the treatment of opioid-induced constipation. Key competitors include other peripherally acting mu-opioid receptor antagonists (PAMORAs).

Drug Name	Active Ingredient	Primary Indication	Approval Date
Movantik (naloxegol)	Naloxegol	Opioid-induced constipation	September 11, 2015 [2]
Amitiza (lubiprostone)	Lubiprostone	Opioid-induced constipation, chronic idiopathic constipation	February 8, 2006 [3]
Relistor (methylnaltrexone bromide)	Methylnaltrexone bromide	Opioid-induced constipation in adults with chronic non-cancer pain; advanced illness	April 23, 2008 [4]

Viatris markets ONTRALFY. Movantik was previously marketed by AstraZeneca and later by Daiichi Sankyo. The market share distribution among these products is influenced by factors such as efficacy, safety profiles, prescribing physician preferences, and formulary placement by payers.

What is the market trajectory of ONTRALFY?

The market trajectory of ONTRALFY is projected to be shaped by its patent expiration dates and the potential for generic competition. The earliest significant patent expiration for the composition of matter is in September 2028. However, specific formulation patents extend further.

The introduction of generic versions of naloxegol following patent expiration is expected to significantly impact ONTRALFY's market share and revenue. Generic competition typically leads to a substantial decrease in drug prices and a corresponding decline in the branded drug's revenue.

Viatris's strategy will likely involve maximizing revenue during the remaining period of exclusivity and preparing for the eventual generic entry. This could include strategies focused on physician education, patient access programs, and lifecycle management initiatives, though the latter is less common for older molecules.

The financial performance of ONTRALFY will be directly correlated with its market exclusivity period. As patents approach expiration, market analysts will monitor for any patent litigation that could either uphold or challenge the validity of these patents, potentially leading to earlier or later generic entry.

What are the key patent litigation events?

While specific details of ongoing patent litigation are often proprietary and not publicly disclosed until filed in court, patent challenges are a standard part of the pharmaceutical market landscape. Generic manufacturers often file Paragraph IV certifications under Hatch-Waxman, challenging the validity or non-infringement of existing patents. Such challenges can lead to lengthy and complex legal battles. Any successful challenge by a generic company could trigger a 180-day exclusivity period for the first generic filer, accelerating market entry and significantly impacting the branded drug's sales.

Key Takeaways

• ONTRALFY's market exclusivity is supported by patents expiring between 2028 and 2030, and by regulatory NCE exclusivity granted in 2015.
• The primary composition of matter patent for naloxegol expires in September 2028.
• Competition exists from other PAMORAs and laxatives, impacting ONTRALFY's market share.
• Generic entry following patent expiration is anticipated to reduce ONTRALFY's market share and revenue.
• Patent litigation remains a potential factor influencing the timing of generic competition.

Frequently Asked Questions

1. When is the earliest a generic version of ONTRALFY could be approved? The earliest a generic version could be approved is dependent on the expiration of the relevant patents and any successful patent challenges. The composition of matter patent expires in September 2028. However, regulatory exclusivity periods and potential patent litigation could alter this timeline.

2. What are the main therapeutic alternatives to ONTRALFY? Key therapeutic alternatives include Relistor (methylnaltrexone bromide) and Amitiza (lubiprostone). Other laxative classes are also used for opioid-induced constipation.

3. What is the significance of Viatris's role in the ONTRALFY market? Viatris is responsible for the commercialization and marketing of ONTRALFY. Its strategic decisions regarding pricing, distribution, and market access will influence the drug's financial performance during its period of exclusivity.

4. How does patent term extension affect ONTRALFY's market exclusivity? Patent term extension provides an additional period of market exclusivity to compensate for patent life lost during the FDA regulatory review process. This extends the effective patent life beyond the original expiration date.

5. What is the expected impact of generic entry on ONTRALFY's pricing? Historically, the introduction of generic drugs leads to a significant decrease in pricing for both the generic and, to a lesser extent, the branded product, as market competition intensifies.

Citations

[1] United States Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from USPTO Patent Center. (Specific patent numbers searched: 8,394,821; 9,320,795; 9,040,056).

[2] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages. Retrieved from FDA website. (Accessed via FDA's Drugs@FDA database for Movantik).

[3] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages. Retrieved from FDA website. (Accessed via FDA's Drugs@FDA database for Amitiza).

[4] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages. Retrieved from FDA website. (Accessed via FDA's Drugs@FDA database for Relistor).