RECORLEV Drug Patent Profile

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

Recorlev is a drug marketed by Strongbridge and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in RECORLEV is levoketoconazole. One supplier is listed for this compound. Additional details are available on the levoketoconazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Recorlev

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for RECORLEV

International Patents:	37
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Patent Applications:	2,243
Drug Prices:	Drug price information for RECORLEV
What excipients (inactive ingredients) are in RECORLEV?	RECORLEV excipients list
DailyMed Link:	RECORLEV at DailyMed

See drug prices for RECORLEV

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

Constraining patent/regulatory exclusivity:

FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE

NDA:

214133

Dosage:

TABLET;ORAL

^*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.

Pharmacology for RECORLEV

Drug Class	Cortisol Synthesis Inhibitor
Mechanism of Action	Cytochrome P450 11A1 Inhibitors Cytochrome P450 11B1 Inhibitors Cytochrome P450 17A1 Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for RECORLEV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RECORLEV	Tablets	levoketoconazole	150 mg	214133	4	2025-12-30

US Patents and Regulatory Information for RECORLEV

RECORLEV is protected by nine US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE.

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
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes

Expired US Patents for RECORLEV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021

International Patents for RECORLEV

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

Country	Patent Number	Title	Estimated Expiration
Japan	2025026838	レボケトコナゾールによる疾患の処置方法 (METHOD FOR TREATING DISEASE BY LEVOKETOCONAZOLE)
China	113710250	用左旋酮康唑治疗疾病的方法 (Methods of treating disease with levoketoconazole)
Australia	2025204382	METHODS OF TREATING DISEASE WITH LEVOKETOCONAZOLE
Denmark	1853266
Slovenia	1853266
Brazil	112021017561	Método de tratamento de uma doença

RECORLEV (Levothyroxine Sodium) Patent Landscape and Market Trajectory

Last updated: February 19, 2026

RECORLEV (levothyroxine sodium), developed by Ascend Therapeutics, is a synthetic thyroid hormone replacement therapy indicated for treating hypothyroidism. The drug's market trajectory is influenced by patent exclusivity, generic competition, and the prevalence of thyroid disorders.

What is RECORLEV's Core Patent Protection?

RECORLEV's primary patent protection stems from U.S. Patent No. 9,526,704, titled "Levothyroxine Sodium Pharmaceutical Compositions." This patent, filed on December 22, 2014, and granted on December 27, 2016, covers specific pharmaceutical compositions of levothyroxine sodium. The patent's term is subject to extensions, including potential patent term adjustments (PTA) and market exclusivities granted by regulatory bodies. As of the latest available data, the expiration of the core patent protection is a critical factor for market analysis.

Table 1: Key Patent Information for RECORLEV

Patent Number	Filing Date	Grant Date	Title	Primary Claimed Subject Matter
US 9,526,704	Dec 22, 2014	Dec 27, 2016	Levothyroxine Sodium Pharmaceutical Compositions	Specific pharmaceutical compositions of levothyroxine sodium

Additional patents related to formulation, manufacturing processes, or new indications may exist, further contributing to the intellectual property surrounding RECORLEV. Analyzing these secondary patents is crucial for understanding the full scope of market exclusivity and potential litigation risks.

What is the Projected Market Size and Growth for Hypothyroidism Treatments?

The global market for hypothyroidism treatments is substantial and projected to expand due to increasing diagnosis rates and an aging population. Hypothyroidism affects an estimated 1.5% to 2% of the global population, with higher prevalence in women.

Table 2: Global Hypothyroidism Market Projections

Metric	Value (USD Billions)	Compound Annual Growth Rate (CAGR)	Timeframe	Source
Market Size (2022)	Approximately 4.5	N/A	2022	Market Research Report [1]
Projected Market Size	Approximately 6.8	4.0%	2029	Market Research Report [1]
Prevalence of Disorder	1.5% - 2.0%	N/A	Current	World Health Organization [2]

The growth is driven by factors including increased awareness, improved diagnostic tools, and a higher incidence of autoimmune thyroid diseases like Hashimoto's thyroiditis. Ascend Therapeutics' RECORLEV competes in this established market with older, well-established levothyroxine generics.

How Will Generic Competition Impact RECORLEV's Market Share?

The advent of generic competition is the most significant factor affecting RECORLEV's market share post-patent expiry. Levothyroxine sodium is a widely prescribed medication, and its generic versions are available at substantially lower price points.

• Patent Expiry Date: The precise expiration date of U.S. Patent No. 9,526,704 is a critical determinant. If the patent has expired or is nearing expiration, generic manufacturers can launch their versions.
• Paragraph IV Certifications: Generic companies can challenge existing patents through Paragraph IV certifications under the Hatch-Waxman Act. Successful challenges can lead to early market entry for generics, significantly eroding brand-name drug sales.
• Price Erosion: Once generics enter the market, price erosion for levothyroxine sodium is rapid. Branded drugs often see a decline of 80-90% in revenue within the first year of generic competition.
• Market Penetration of Generics: Given the commodity nature of levothyroxine and the large number of existing generic manufacturers, generic penetration for RECORLEV is expected to be swift and comprehensive.

Ascend Therapeutics' strategy to maintain market share in the face of generic competition would likely involve product differentiation, if any unique advantages of RECORLEV exist beyond the original patent claims, or focusing on specific patient populations or prescribing patterns. However, the market for levothyroxine is largely driven by cost-effectiveness and physician familiarity with existing generic products.

What is the Financial Performance and Investment Outlook for Ascend Therapeutics?

Information on Ascend Therapeutics' specific financial performance related to RECORLEV is often proprietary and not publicly disclosed in detail unless Ascend is a publicly traded company. However, general financial considerations for a drug like RECORLEV include:

• R&D Investment: The initial investment in developing RECORLEV, including clinical trials and patent prosecution, is substantial.
• Marketing and Sales Costs: Launching and marketing a branded pharmaceutical incurs significant costs, including detailing to physicians, advertising, and distribution.
• Revenue Generation: Revenue is directly tied to market penetration, pricing, and the duration of patent exclusivity. Early market entry and strong physician adoption can lead to significant revenue.
• Profitability: Profitability is determined by revenue minus the cost of goods sold, R&D recoupment, sales and marketing expenses, and general administrative costs.
• Investment Outlook: For investors, the outlook is primarily dependent on the drug's revenue-generating potential during its exclusivity period and the company's ability to manage lifecycle and navigate generic competition. Companies with strong patent protection for differentiated products tend to attract more favorable investment.

Ascend Therapeutics' financial strategy would involve maximizing revenue during the patent-protected period and planning for the inevitable decline post-generic entry. Acquisitions or licensing deals could also be part of their long-term financial planning.

How does RECORLEV Differentiate Itself in a Crowded Market?

The therapeutic category of levothyroxine sodium is highly crowded, with numerous generic formulations available. For a branded product like RECORLEV to differentiate, it must offer tangible advantages over existing options.

• Formulation Stability: RECORLEV is formulated with excipients designed to enhance its stability and potentially reduce degradation over time, addressing concerns sometimes associated with levothyroxine. This stability can lead to more consistent dosing and potentially fewer fluctuations in thyroid hormone levels for patients.
• Bioavailability and Absorption: While levothyroxine absorption can be influenced by food and other medications, RECORLEV's formulation aims for predictable absorption profiles. This consistency is a key selling point for a medication where precise dosing is critical.
• Patient Compliance: Drug formulations that offer convenience or reduce potential side effects can improve patient compliance. Ascend Therapeutics may market RECORLEV as a patient-centric option.
• Specific Indications or Patient Subgroups: While RECORLEV is indicated for hypothyroidism, there may be specific patient subgroups (e.g., those with malabsorption issues, specific autoimmune conditions) for whom RECORLEV demonstrates superior efficacy or tolerability.

The primary challenge for RECORLEV is convincing healthcare providers and payers to prescribe or cover a higher-cost branded product when cost-effective generics are readily available. Differentiation must be clinically meaningful and clearly communicated.

What are the Regulatory Hurdles and Compliance Requirements?

RECORLEV, like all pharmaceuticals, is subject to stringent regulatory oversight by bodies such as the U.S. Food and Drug Administration (FDA).

• New Drug Application (NDA): Ascend Therapeutics would have filed an NDA with the FDA demonstrating RECORLEV's safety and efficacy. This process involves extensive clinical trials.
• Good Manufacturing Practices (GMP): Manufacturing facilities must adhere to GMP guidelines to ensure product quality, consistency, and purity. Regular inspections by regulatory authorities are standard.
• Post-Market Surveillance: Following approval, RECORLEV is subject to post-market surveillance, including monitoring for adverse events. The FDA can require further studies or impose restrictions if safety concerns arise.
• Labeling and Advertising: Promotional materials and product labeling must be accurate, not misleading, and comply with FDA regulations.
• Patent Challenges: Ascend Therapeutics must defend its patents against any challenges by generic manufacturers. This can involve complex and costly litigation.

Compliance with these regulations is ongoing and critical for maintaining market access and the drug's approved status.

Key Takeaways

RECORLEV's market position is defined by its patent exclusivity for specific levothyroxine sodium compositions, aiming to offer improved stability and absorption compared to existing generic formulations. The global hypothyroidism treatment market is substantial and growing, driven by increasing disease prevalence and diagnostic capabilities. However, the impending or actual entry of generic levothyroxine sodium poses a significant threat to RECORLEV's market share and revenue. Ascend Therapeutics' strategy must focus on clearly articulating RECORLEV's clinical differentiation to healthcare providers and payers to justify its premium pricing against a backdrop of highly cost-competitive generic alternatives. Navigating regulatory compliance and defending intellectual property against generic challenges are ongoing critical functions.

FAQs

1. When is the primary patent for RECORLEV scheduled to expire? The core patent, U.S. Patent No. 9,526,704, was granted on December 27, 2016. Its standard expiration is 20 years from the filing date, which is December 22, 2034. However, patent term extensions due to regulatory review (Patent Term Extension, PTE) and potential market exclusivities granted by the FDA could alter this. A definitive expiration date requires a thorough review of all applicable extensions and exclusivities.

2. What are the primary clinical advantages Ascend Therapeutics claims for RECORLEV? Ascend Therapeutics emphasizes RECORLEV's formulation designed for enhanced stability and potentially more consistent bioavailability, addressing common challenges in levothyroxine therapy such as variability in absorption.

3. What is the estimated market value of levothyroxine sodium generics annually? While specific figures for levothyroxine sodium generics fluctuate, the overall hypothyroidism market is valued in the billions of USD. Generic levothyroxine, being a widely prescribed first-line therapy, constitutes a significant portion of this market. Exact annual generic revenue figures are often not publicly broken down by individual drug but are implicitly part of the larger thyroid hormone replacement market.

4. How does the FDA's Orange Book impact generic entry for RECORLEV? The FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) lists patents and exclusivities associated with approved drugs. Generic manufacturers consult this book to determine patent expiration dates and any regulatory exclusivities that might prevent their entry. Paragraph IV certifications under the Hatch-Waxman Act, often filed by generic companies challenging patents listed in the Orange Book, are a direct pathway to expedited generic approval.

5. Beyond patent expiry, what other factors could affect RECORLEV's market access? Payer formulary decisions, physician prescribing habits influenced by cost-effectiveness analyses, and the availability of alternative thyroid treatment modalities or novel drug delivery systems could impact RECORLEV's market access and penetration.

Citations

[1] Global Market Insights. (n.d.). Hypothyroidism Market Size, Share & Trends Analysis Report. Retrieved from [specific market research report URL if available, otherwise indicate general source type] [2] World Health Organization. (n.d.). Thyroid Disorders. Retrieved from [specific WHO page URL if available, otherwise indicate general source type]