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 forty 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 have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for RECORLEV

International Patents:	40
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Patent Applications:	2,314
Drug Prices:	Drug price information for RECORLEV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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	12,377,096
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	9,918,984
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	10,835,530
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	11,903,940
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	11,278,547
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	11,478,471

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	10,098,877
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021	10,835,530
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021	10,517,868
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021	11,478,471

International Patents for RECORLEV

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

Country	Patent Number	Title	Estimated Expiration
Austria	E528005
Australia	2006204334	Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Canada	2594433	PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DU DIABETE, DU SYNDROME METABOLIQUE ET D'AUTRES CONDITIONS (METHODS AND COMPOSITIONS FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITIONS)
China	101141964	Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Cyprus	1112519
Denmark	1853266

RECORLEV (somapacitan-beco) market dynamics and financial trajectory: exclusivity, payer leverage, uptake drivers, competitive risks, and revenue outlook

Last updated: July 30, 2026

RECORLEV (somapacitan-beco, once-weekly human growth hormone [hGH] analog) is in the early commercialization phase in the US and multiple geographies, with market share and revenue still dominated by broader class competitors (daily lonapeg/somatropin, weekly somatrogon, and other growth hormone therapies). Financial trajectory hinges on (1) label breadth and persistence for pediatric growth hormone deficiency (GHD) and adult GHD, (2) payer contracting of weekly injection products versus daily regimens, (3) competitive access and biosimilar pressure in the underlying hGH category, and (4) the company’s ability to convert early prescribers into long-term, continuously treated cohorts.

What is RECORLEV (somapacitan-beco) and what market does it target?

Quick answer: RECORLEV is a once-weekly growth hormone replacement therapy for children with growth hormone deficiency and for adults with growth hormone deficiency, marketed to replace daily hGH injections with a lower injection-frequency regimen.

Which patient populations drive revenue?

RECORLEV’s commercial base depends on durable treatment among:

• Pediatric GHD: long-term therapy with growth velocity targets and routine monitoring.
• Adult GHD: lower incidence than pediatric use but higher payer scrutiny around efficacy, dosing stability, and safety monitoring.
• Switching dynamics: patients on daily somatropin formulations are the most relevant conversion pool because weekly dosing can improve adherence.

What delivery and administration profile matters commercially?

Once-weekly injection reduces injection burden versus daily somatropin products, which typically improves adherence and can support favorable formulary positioning when payers accept the higher per-dose acquisition cost.

What is the competitive set in growth hormone markets?

RECORLEV is competing within growth hormone replacement, where payers also evaluate:

• Daily somatropin products (broad coverage, often subject to biosimilar competition in some countries)
• Other weekly growth hormone analogs (where available), which create class switching pressure

How do exclusivity timelines shape RECORLEV’s financial trajectory?

Quick answer: RECORLEV’s revenue curve is tightly linked to expected patent and regulatory exclusivity windows, the timing of generic or biosimilar erosion risk (where applicable), and whether payers lock in weekly class contracts before entry.

What exclusivity protects RECORLEV first in the US?

RECORLEV’s US commercial trajectory is supported by a combination of:

• New drug (new molecular entity) exclusivity
• Orphan drug exclusivity only if applicable (not assumed here)
• Patent protection on composition of matter, formulations, and methods

Because growth hormone products often face biosimilar dynamics in broader categories, the key is whether RECORLEV is treated as a standalone product with strong patent coverage, limiting “work-around” development.

When does RECORLEV lose exclusivity?

A complete, date-specific exclusivity map requires Orange Book listing data and patent term calculations tied to FDA approval and any patent term adjustments. Without validated listing-level data, a precise “lose exclusivity” date cannot be stated.

What is the Orange Book status of RECORLEV and how does it impact generic risk?

Quick answer: Orange Book status determines whether generic substitution is realistically possible and which patents can be targeted via Paragraph IV certifications.

What patent categories typically drive exclusivity risk for weekly hGH analogs?

For novel weekly biologic-like small molecules or analogs, risk usually concentrates around:

• Composition-of-matter patents
• Formulation and dosing device patents
• Manufacturing process patents
• Method-of-use patents tied to specific dosing schedules or patient subsets

What generic entry risks exist for RECORLEV?

Generic risk depends on patent barriers and regulatory classification. For regulated injectable growth hormone analogs, entry is often constrained by:

• Demonstrating bioequivalence for complex pharmacokinetics
• IP around release kinetics and formulation stability
• Method-of-use claims that cover dosing schedules

A credible entry scenario requires patent-by-patent mapping to FDA approvals and certifications, which is not provided here.

What market dynamics govern RECORLEV adoption: payer, prescriber, and adherence?

Quick answer: Weekly dosing can accelerate uptake when payers support a step-therapy or prior authorization pathway that rewards lower injection frequency. Prescriber adoption depends on switching comfort, real-world persistence, and reassurance on growth outcomes and safety.

Payer contracting: how weekly products win or lose

Payers evaluate RECORLEV on:

• Total cost of care (drug cost plus injection supply, administration time, and monitoring)
• Adherence and persistence metrics (fewer missed doses)
• Clinical outcomes used in formulary decisions (growth velocity proxies)
• Budget impact within pediatric and adult cohorts

Weekly hGH products can win if:

• they are offered with competitive net pricing via rebate structures
• payers accept fewer prior authorization hurdles due to clearer adherence advantages

Weekly products can stall if:

• net price remains too high relative to daily comparators
• payers require step therapy through daily agents first

Real-world adoption levers

Commercial uptake usually improves when:

• prescribers can quickly identify eligible switch patients
• pharmacy benefit managers (PBMs) set simple coverage criteria
• patient support programs reduce out-of-pocket costs

Uptake tends to slow when:

• prior authorization and dosing confirmation create friction
• payers impose narrow criteria for switching from daily therapy

Which companies are challenging RECORLEV and how does competitive pressure affect pricing?

Quick answer: Competitive pressure in growth hormone markets comes from daily somatropin portfolios and any other weekly growth hormone analogs that offer payer-friendly contracting and patient support.

How does RECORLEV pricing evolve with competitive entry?

Pricing trajectory typically follows this pattern:

• initial pricing anchored to clinical differentiation claims and weekly convenience
• later downward pressure via
  • payer reference pricing
  • rebate renegotiations
  • formulary inclusion without preferred tier status

Net price depends more on PBM contracting than list price once coverage spreads beyond early adopters.

What is the main competitive threat: substitution or budget substitution?

There are two distinct threats:

1. Therapeutic substitution: weekly analogs displacing each other.
2. Budget substitution: payers keeping patients on daily biosimilar-heavy regimens with strong cost offsets.

RECORLEV’s financial trajectory depends on whether it captures share through switching or loses patients to daily therapies at renewal time.

How strong is the patent estate for RECORLEV and what litigation risks matter?

Quick answer: Patent strength determines whether competitive entry is delayed long enough to sustain revenue ramp. Litigation risk influences timeline certainty and negotiating leverage with generics or biosimilar entrants.

What patent litigation affects RECORLEV?

Risk typically includes:

• patent infringement suits by the originator
• Paragraph IV challenges (if applicable)
• settlement agreements that delay entry but can trigger earlier “at-risk” launch scenarios after carve-outs

A complete litigation picture requires access to case dockets and court filings tied to specific Orange Book patents.

What formulation and manufacturing IP barriers protect RECORLEV?

Quick answer: For injectables, formulation and manufacturing process IP can be as important as composition-of-matter, because it can block “just make the same molecule” generic approaches.

Typical formulation IP that constrains competitors

• stabilizers and excipients tied to storage and injection performance
• release and solubility characteristics enabling once-weekly dosing
• fill-finish and device-related IP (where relevant)

Manufacturing scale-up risk that affects revenue timing

A revenue trajectory can be constrained by:

• supply availability in the first 12 to 24 months
• lot release timelines tied to quality controls
• distribution expansion into additional geographies

How do FDA status and regulatory milestones influence RECORLEV revenue timing?

Quick answer: Revenue timing depends on the speed of label expansion, regulatory approvals in major markets, and the maturation of reimbursement coverage by national and regional payers.

What regulatory milestones usually move the financial needle?

• new indications or pediatric expansions
• revised dosing guidance that expands eligible patient segments
• approvals in additional countries that create new addressable markets
• safety updates that influence payer risk tolerance

A precise regulatory timeline requires verified milestone dates.

What are the likely revenue drivers and cost headwinds for RECORLEV?

Quick answer: Revenue ramps with adoption and persistence, while cost headwinds come from contracting concessions, patient support spend, manufacturing costs, and life-cycle compliance costs.

Revenue drivers

• Patient switching from daily therapy
• Persistence through long-term treatment
• Geographic expansion and reimbursement maturation
• Net price realization via contracting

Cost headwinds

• manufacturing scale and quality systems
• rebates and payer concessions
• distribution and medical education spending
• pharmacovigilance and postmarketing commitments

RECORLEV financial trajectory scenario analysis (US-centered)

Quick answer: RECORLEV’s financial trajectory should be modeled as an S-curve: early adoption among high-conversion prescribers, followed by acceleration as payers contract and switch pathways widen, then leveling as the remaining pool becomes harder to convert due to daily therapy cost advantages.

Scenario framework for decision-making

Use three levers:

1. Share capture
   • share growth depends on payer tier status and prior authorization friction
2. Net price
   • net price erosion from rebate pressure typically slows once RECORLEV becomes a standard option within weekly dosing lists
3. Persistence
   • discontinuation driven by injection preferences, supply disruptions, or perceived efficacy plateaus reduces lifetime value

What would indicate an upside vs downside trajectory?

• Upside signals: broad formulary acceptance, high switch rates, stable net pricing, strong persistence.
• Downside signals: heavy rebate pressure, narrow eligibility criteria for switching, higher than expected discontinuation.

A numerical forecast cannot be produced without audited financials, current unit sales, net price, and official guidance.

Key Takeaways

• RECORLEV’s market dynamics are driven by weekly convenience, payer contracting mechanics, and long-term persistence in pediatric and adult GHD cohorts.
• Competitive pressure is structural: daily somatropin and potential weekly comparators can force net price concessions even if clinical differentiation supports continued use.
• Patent and regulatory exclusivity timing will shape the pace of competitive erosion, but a date-specific exclusivity and Orange Book risk assessment cannot be stated without validated listing-level data.
• Financial trajectory is best modeled through share capture, net price realization, and persistence, with adoption friction (prior authorization and step therapy) the main near-term limiter.

FAQs

1. What payer criteria typically determine access to weekly growth hormone therapies like RECORLEV?
2. How does patient switching from daily somatropin to weekly somapacitan-beco usually affect long-term revenue persistence?
3. What competitive factors matter most when payers benchmark weekly growth hormone options against daily biosimilar-heavy regimens?
4. How do patent settlement structures and launch carve-outs change timing of generic or biosimilar threats for injectable growth hormone therapies?
5. What indicators from real-world utilization most reliably predict whether RECORLEV will gain sustained formulary position over time?

References

No sources were provided for RECORLEV’s Orange Book listings, exclusivity dates, litigation status, or financial/unit sales. Therefore, no cited references can be listed.