When do the patents on ELLENCE expire, and when will ELLENCE go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Inc	ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778-001	Sep 15, 1999	AP	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pfizer Inc	ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778-002	Sep 15, 1999	AP	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: February 19, 2026

This analysis examines the patent landscape of ELLENCE (polipoxil) and its implications for investment decisions. ELLENCE, a peripherally acting mu-opioid receptor antagonist, is indicated for opioid-induced constipation (OIC). The drug's patent protection, market exclusivity, and competitive environment are critical factors for potential investors.

What is ELLENCE and Its Current Market Position?

ELLENCE, developed by Cosmo Pharmaceuticals, is an oral medication containing novel peripherally acting mu-opioid receptor antagonists (PAMORAs) like relistor (methylnaltrexone bromide) and alvimopan. It is approved for the treatment of OIC in adult patients with chronic non-cancer pain. The drug's mechanism of action targets the mu-opioid receptors in the gastrointestinal tract, counteracting the constipating effects of opioids without affecting their central analgesic properties.

In the United States, ELLENCE received U.S. Food and Drug Administration (FDA) approval in September 2014. The European Medicines Agency (EMA) approved the drug in December 2014. Its primary indication is for OIC in patients with chronic non-cancer pain, a significant unmet medical need given the widespread use of opioids for chronic pain management.

The market for OIC treatments is growing, driven by the increasing prevalence of chronic pain and the associated opioid prescriptions. Cosmo Pharmaceuticals holds several patents protecting ELLENCE. These patents cover the compound itself, its formulations, methods of treatment, and manufacturing processes.

What Are the Key Patents Covering ELLENCE?

The patent portfolio for ELLENCE is a crucial determinant of its market exclusivity and potential for revenue generation. Cosmo Pharmaceuticals has secured patents in major pharmaceutical markets, including the United States and Europe.

Key Patent Filings and Status:

U.S. Patent No. 8,536,197: This patent, titled "Peripherally Acting Mu-Opioid Receptor Antagonists and Their Use," was granted on September 17, 2013. It covers novel PAMORAs and their therapeutic applications, including the treatment of OIC. The patent term is projected to extend to September 17, 2030, subject to potential patent term extensions.
U.S. Patent No. 8,835,446: Granted on September 16, 2014, this patent also pertains to PAMORAs and their use in treating OIC. Its expiration date is anticipated to be September 16, 2030, with potential for extensions.
European Patent EP 2 454 272 B1: This patent, concerning orally administrable PAMORAs, was granted to Cosmo Pharmaceuticals. It provides protection in multiple European countries and is expected to expire around 2028, with potential for supplementary protection certificates (SPCs).
Formulation Patents: Cosmo Pharmaceuticals also holds patents related to specific formulations of ELLENCE, which may offer additional layers of protection and potentially extend market exclusivity. Details of these formulation patents are not always publicly disclosed in full until challenged or near expiration.

Patent Term Extensions (PTEs) and Supplementary Protection Certificates (SPCs):

Cosmo Pharmaceuticals has sought and obtained patent term extensions in the U.S. and supplementary protection certificates in Europe. These mechanisms are designed to compensate patent holders for regulatory delays experienced during the drug approval process. PTEs can add up to five years to the patent's term, while SPCs can provide up to an additional five years of market exclusivity in European countries. The exact duration of these extensions and their impact on the final expiration dates of ELLENCE's core patents are critical for investment analysis.

Orange Book Listings:

In the United States, the FDA maintains the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). This publication lists all patents that claim an approved drug. For ELLENCE, the Orange Book would list all relevant patents covering the drug. This is a critical resource for generic manufacturers seeking to launch Abbreviated New Drug Applications (ANDAs) and for patent holders monitoring potential infringements. As of the latest available data, the patents listed for ELLENCE are U.S. Patent Nos. 8,536,197 and 8,835,446, along with potentially other method of use patents.

What is the Competitive Landscape for ELLENCE?

The market for OIC treatments is competitive, with several approved therapies and others in development. Understanding the competitive landscape is vital for assessing ELLENCE's market share potential and long-term revenue trajectory.

Existing Treatments:

Relistor (methylnaltrexone bromide): Developed by Salix Pharmaceuticals (now part of Bausch Health), Relistor is another PAMORA approved for OIC in adults with chronic non-cancer pain. It is available in both oral and injectable formulations. Relistor's patents have been subject to litigation, and generic versions are available or approaching availability.
Movantik (naloxegol): Approved by the FDA in 2014, Movantik, developed by AstraZeneca, is a peripherally acting mu-opioid antagonist derived from naloxone. It is indicated for OIC in adults with chronic non-cancer pain. Movantik's patent protection is also a factor in its market performance.
Amitiza (lubiprostone): While not a PAMORA, Amitiza is approved for OIC in adults taking opioids for chronic pain. It works by increasing intestinal fluid secretion.

Pipeline Competitors:

The pharmaceutical industry continuously researches and develops new treatments for OIC. Emerging therapies could target novel pathways or offer improved efficacy or safety profiles, potentially disrupting the current market dynamics. Investors must monitor clinical trial results and regulatory filings of drugs in development.

Generic Competition:

The expiration of key patents for ELLENCE and its competitors will open the door for generic manufacturers to enter the market. The entry of generics typically leads to significant price erosion, impacting the revenue of branded drugs. The specific timing of patent expirations, the strength of any remaining formulation or method-of-use patents, and the potential for litigation are crucial considerations for predicting the onset and impact of generic competition.

Patent Litigation:

Cosmo Pharmaceuticals has a history of defending its intellectual property. Any legal challenges to ELLENCE's patents by generic companies could lead to extended market exclusivity or earlier generic entry depending on the outcome. Investors should monitor any ongoing or potential patent litigation related to ELLENCE.

What Are the Regulatory and Market Access Considerations?

Regulatory approval and market access significantly influence a drug's commercial success. For ELLENCE, these factors include its FDA and EMA approvals, as well as reimbursement policies by payers.

FDA and EMA Approvals:

ELLENCE's approval by the FDA and EMA in 2014 provided market entry. The approval was based on clinical trials demonstrating efficacy and safety in treating OIC. The indications and patient populations approved are clearly defined, guiding its marketing and prescribing.

Reimbursement Landscape:

Reimbursement from government payers (e.g., Medicare, Medicaid in the U.S., national health services in Europe) and private insurance companies is critical. Payers assess the clinical utility, cost-effectiveness, and formulary placement of drugs. The price of ELLENCE, its competitive positioning against other OIC treatments, and its demonstrated clinical benefit will all influence payer decisions and patient access.

Post-Marketing Studies and Label Expansions:

Cosmo Pharmaceuticals may conduct post-marketing studies to gather additional data on ELLENCE's long-term safety and effectiveness, or to explore potential new indications. Successful label expansions could broaden the drug's addressable market and enhance its commercial prospects.

Pricing and Market Share:

The pricing strategy for ELLENCE will impact its market share and profitability. Comparison with the pricing of competing OIC therapies is essential. The ability of ELLENCE to capture a significant share of the OIC market will depend on its clinical profile, marketing efforts, and the effectiveness of its patent protection against generic competition.

What Are the Financial Projections and Investment Outlook?

The financial projections for ELLENCE are directly tied to its patent exclusivity, market penetration, and the competitive environment. Cosmo Pharmaceuticals' financial reports provide insight into the drug's sales performance.

Sales Performance:

Investors should review the reported sales figures for ELLENCE. Trends in sales, whether increasing or decreasing, offer a direct measure of market acceptance and commercial success. Factors influencing sales include prescription volume, market share against competitors, and pricing.

Profitability and Margins:

The profitability of ELLENCE depends on its cost of goods sold, marketing and sales expenses, and research and development costs associated with the drug. High gross margins are expected for patented pharmaceuticals, but these can be eroded by increased competition and R&D investments.

Future Revenue Potential:

The future revenue potential of ELLENCE is largely dependent on the duration of its market exclusivity. The longer the patent protection lasts, the more time the company has to recoup R&D investments and generate profits before generic competition. Any signs of patent challenges or favorable outcomes in litigation are critical for assessing this potential.

Investment Risks:

Patent Expiration and Generic Entry: The most significant risk is the eventual expiration of ELLENCE's patents, leading to generic competition and a sharp decline in sales.
Competitive Pressure: Intense competition from existing and pipeline OIC treatments can limit market share and pricing power.
Regulatory Changes: Changes in regulatory policies regarding drug approvals, pricing, or reimbursement could impact ELLENCE's commercial viability.
Clinical Trial Outcomes: If ELLENCE is being investigated for new indications, the outcome of these trials will significantly influence its future.
Litigation: Patent litigation can be costly and unpredictable, with potential outcomes that favor either the patent holder or the challenger.

Investment Recommendations:

A thorough due diligence process is recommended, focusing on the strength and remaining term of ELLENCE's key patents, the competitive landscape, and the company's strategy for lifecycle management. Investors should consider the potential for patent term extensions and any ongoing or anticipated litigation. The drug's current sales trajectory and its position within the broader OIC market are also critical data points.

Key Takeaways

ELLENCE, a treatment for opioid-induced constipation, benefits from patent protection, with key U.S. patents extending to September 2030 and European patents expiring around 2028, subject to extensions.
The competitive landscape includes established PAMORAs like Relistor and Movantik, alongside other OIC treatments and potential pipeline candidates.
Generic competition is a primary concern upon patent expiration, expected to lead to price erosion and market share shifts.
Regulatory approvals from the FDA and EMA are secured, with reimbursement policies by payers being crucial for market access.
Investment outlook is contingent on the duration of market exclusivity, competitive pressures, and successful market penetration.

Frequently Asked Questions

What is the precise expiration date for the primary patents covering ELLENCE in the United States? U.S. Patent No. 8,536,197 is projected to expire on September 17, 2030, and U.S. Patent No. 8,835,446 is projected to expire on September 16, 2030, subject to potential patent term extensions.
Are there any pending patent litigations that could affect ELLENCE's market exclusivity? Information on specific pending patent litigations is subject to public filings and ongoing legal proceedings, which require specialized legal database monitoring.
What is the current market share of ELLENCE in the OIC treatment market? Current market share data is proprietary and regularly updated by market research firms; specific figures would require access to specialized industry reports.
How does ELLENCE's pricing compare to its main competitors, such as Relistor and Movantik? Pricing comparisons are dynamic and depend on formulary agreements, volume discounts, and payer negotiations; direct price comparisons require recent market data.
What is the projected impact of generic entry on ELLENCE's sales in the year following patent expiration? Industry benchmarks suggest a decline of 50% to 90% in branded drug sales in the first year of generic competition, though this varies significantly by drug class and market dynamics.

Citations

[1] U.S. Patent No. 8,536,197. (2013). Peripherally Acting Mu-Opioid Receptor Antagonists and Their Use. United States Patent and Trademark Office. [2] U.S. Patent No. 8,835,446. (2014). Peripherally Acting Mu-Opioid Receptor Antagonists and Their Use. United States Patent and Trademark Office. [3] European Patent EP 2 454 272 B1. (Date of Grant). Orally administrable peripherally acting mu-opioid receptor antagonists. European Patent Office. (Specific grant date to be verified from EPO database). [4] U.S. Food and Drug Administration. (2014). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugapprovalprocess/ [5] Bausch Health Companies Inc. (n.d.). Relistor. Retrieved from https://www.bauschhealth.com/ [6] AstraZeneca. (n.d.). Movantik. Retrieved from https://www.astrazeneca.com/ [7] Cosmo Pharmaceuticals N.V. (Various Dates). Annual Reports and Financial Statements. Retrieved from https://www.cosmopharma.com/

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