SKYCLARYS Drug Patent Profile

Which patents cover Skyclarys, and what generic alternatives are available?

Skyclarys is a drug marketed by Biogen Us and is included in one NDA. There are seven patents protecting this drug.

This drug has ninety-nine patent family members in forty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Skyclarys

Skyclarys will be eligible for patent challenges on February 28, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 28, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SKYCLARYS

International Patents:	99
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	6
Patent Applications:	176
Drug Prices:	Drug price information for SKYCLARYS
What excipients (inactive ingredients) are in SKYCLARYS?	SKYCLARYS excipients list
DailyMed Link:	SKYCLARYS at DailyMed

See drug prices for SKYCLARYS

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

Constraining patent/regulatory exclusivity:

TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER

NDA:

216718

Dosage:

CAPSULE;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.

Recent Clinical Trials for SKYCLARYS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Biogen	PHASE3
Biogen	PHASE1
Biogen	Phase 1

See all SKYCLARYS clinical trials

Pharmacology for SKYCLARYS

Mechanism of Action

Cytochrome P450 2C8 Inducers Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for SKYCLARYS

SKYCLARYS is protected by eight US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER.

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
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	11,091,430
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	8,993,640		Y	Y
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	9,701,709		Y	Y
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	8,124,799			Y

International Patents for SKYCLARYS

When does loss-of-exclusivity occur for SKYCLARYS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SKYCLARYS around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009237579
Brazil	PI0911457
Canada	2721838
China	102083442

Supplementary Protection Certificates for SKYCLARYS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2841445	CA 2024 00015	Denmark		PRODUCT NAME: OMAVELOXOLON ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/23/1786 20240212
2841445	PA2024511	Lithuania		PRODUCT NAME: OMAVELOKSOLONAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1786 20240209
2841445	LUC00340	Luxembourg		PRODUCT NAME: OMAVELOXOLONE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1786 20240412
2841445	301276	Netherlands		PRODUCT NAME: OMAVELOXOLON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1786 20240212

SKYCLARYS (skyclarys) market dynamics and financial trajectory: pricing, demand drivers, competitor pressure, and loss-of-exclusivity exposure

Last updated: July 27, 2026

Executive summary

• SKYCLARYS is the brand name for naldemedine tablets (8 mg) marketed by Shionogi for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
• The commercial trajectory is shaped by a limited addressable OIC formulary pool, intense class competition from peripherally acting mu-opioid receptor antagonists (PAMORAs), and a growing risk that payer coverage tightens toward lowest-cost alternatives as multi-source entries accumulate.
• Near-to-mid-term revenue performance is most sensitive to (1) formulary wins in OIC lines-of-therapy, (2) persistency and dose continuity, (3) contracting dynamics with PBMs, and (4) the degree to which competing agents expand beyond classic “OIC without laxative” use cases into broader constipation pathways.
• Key financial inflection points for SKYCLARYS are driven by patent/exclusivity expiry timing (formulation, use, and compound), and generic/biosimilar style threats are not the framework here, but small-molecule generics and follow-on launches still determine pricing power.

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SKYCLARYS (naldemedine) market overview: what demand drivers matter for OIC and how big is the paid-use funnel?

SKYCLARYS targets opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Revenue depends on the size of the treated OIC population and how consistently patients stay on a PAMORA regimen after initiation.

What medical demand drives SKYCLARYS utilization?

• Opioid prevalence in chronic non-cancer pain drives the top-of-funnel.
• Constipation severity and inadequate response to traditional laxatives drives PAMORA adoption.
• Switching behavior is critical: patients often cycle between laxatives and PAMORAs; payer rules can force step edits.

Where is the payer “friction”?

• Formularies increasingly separate:
  • OIC with laxative failure vs broader constipation indications
  • PAMORA first-line vs after-step placement
• PBM contracting tends to reward preferred agents with stronger comparative access and lower net price.

Competitive set affects uptake rate

Within OIC PAMORA class, uptake and retention are influenced by:

• Side-effect perception and patient tolerability
• Dosing convenience and prescriber familiarity
• Bottle-to-therapy economics under PBM rebates

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How do SKYCLARYS pricing and payer contracting dynamics influence revenue trajectory?

Financial trajectory for a branded small molecule in OIC typically follows a pattern: early uptake from targeted prescriber penetration, then net price pressure as payer tiers tighten.

Net pricing mechanics for OIC PAMORAs

• List price can remain stable while rebates and patient assistance shift with competition.
• OIC contracting tends to deepen when:
  • multiple PAMORAs are in preferred tiers,
  • PBMs standardize step edits,
  • and generic availability elsewhere in constipation narrows payer tolerance for high-cost brands.

What payment models dominate access?

• Commercial: PBM formulary tiering and prior authorization (PA).
• Medicare Part D: plan formularies, with coverage volatility driven by year-over-year plan design.
• Medicaid: state preferred drug lists and managed-care formularies.

“Brand health” KPI linked to contracting

• Persistence: OIC patients may discontinue if opioid regimens change, if constipation resolves, or if adverse effects occur.
• Dose continuity: SKYCLARYS revenue depends on sustained use rather than one-time treatment.

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What competitors pressure SKYCLARYS in opioid-induced constipation, and how does that change unit economics?

The OIC PAMORA market is crowded enough that competitive dynamics often move revenue via market share and net price rather than market size.

Key competitive vectors

1. Preferred placement: where one PAMORA wins “first-line preferred” within step therapy.
2. Net price compression: when PBMs request deeper rebates to keep a brand off the non-preferred tier.
3. Prescriber switching: after early trial, prescribers keep what works and what is covered.

Typical outcomes in a crowded PAMORA class

• Brands with weaker formulary access show declining share even when patient needs remain constant.
• Brands with stronger contracting can defend revenue longer even as competitor breadth increases.

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What is SKYCLARYS’ financial trajectory: revenue growth, margin profile, and trajectory risk points?

A full financial model requires specific disclosures and annual sales data. Without those inputs, the actionable view is built from structural drivers that govern brand revenue outcomes in OIC.

Structural profit drivers for SKYCLARYS

• Gross margin: driven by rebate and discount intensity, not only COGS.
• Operating leverage: S&M cost discipline and targeted detailing influence profitability as growth slows.
• Channel mix: shift toward plans with lower discounts can stabilize net price.

Downside trajectory triggers

• Tier downgrades (preferred to non-preferred) usually cause a sharper decline than unit demand changes alone.
• PA strictness increases can slow starts and reduce conversions from laxatives to PAMORAs.
• Generic pressure elsewhere in constipation categories can lead PBMs to demand parity rebates even without direct generic substitution for SKYCLARYS.

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When does SKYCLARYS lose exclusivity, and what generic entry risks exist?

Loss of exclusivity is the dominant long-range market dynamic for branded small molecules. However, a defensible “when” and “what expires first” requires Orange Book and patent-by-patent data specific to SKYCLARYS and its NDA.

• SKYCLARYS is a small-molecule brand (not a biologic), so generic small-molecule entry is the primary generic-risk channel.
• Generic entry risk timing is controlled by:
  • primary active ingredient patent expirations
  • secondary patents (formulation, method of use, polymorph, manufacturing)
  • regulatory exclusivities (if applicable) and patent term adjustments.

Without a patent-by-patent expiry table for SKYCLARYS tied to its FDA approval and Orange Book listings, precision on dates and likely Paragraph IV windows cannot be produced from this prompt.

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What does SKYCLARYS’ FDA regulatory status imply for competition: approvals, line extensions, and label-constrained volume?

Regulatory posture affects adoption because payer coverage often mirrors label scope.

How label scope impacts market size

• If the label is narrow to OIC in chronic non-cancer pain, it limits capture of broader constipation prescribers.
• If the label is constrained by adult-only or specific patient populations, it shapes prescriber willingness and PA requirements.

What happens when competing agents expand label scope

• Broader label scope can increase “eligible patients” and shorten the path to insurance approval.
• Narrower label agents can face step edits that further shrink conversion.

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How does SKYCLARYS compare with other PAMORAs on practical prescribing constraints?

Within OIC, differentiation typically shows up in:

• tolerability profile,
• constipation response time,
• and prescribing work flow.

Prescriber workflow considerations

• whether clinicians view it as a default switch after laxative failure,
• whether PA is required in most plans,
• and whether nurses/pharmacists treat it as a standard OIC pathway.

Patient adherence dynamics

• OIC therapy can be stop-start with opioid regimen changes.
• Agents with fewer discontinuations support stronger net revenue retention.

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Commercial exposure analysis for SKYCLARYS: where revenue is most vulnerable

Even without financial disclosures, the exposure map for an OIC brand is consistent:

Most vulnerable revenue streams

• Commercial lives on PBM formularies with restricted PAMORA tiers.
• Plans with step therapy requiring laxative failure documentation.
• Patients transitioned to alternative opioid regimens where constipation changes reduce ongoing need for PAMORAs.

More resilient revenue streams

• Patients with persistent OIC despite laxatives where PAMORA conversion rates remain high.
• Settings where OIC pathways are standardized (managed pain clinics, oncology supportive care protocols when label supports).

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Key takeaways

• SKYCLARYS is positioned in the opioid-induced constipation PAMORA segment, where revenue is driven by formulary placement, PA/step-edit mechanics, patient persistency, and net price contracting more than by broad market growth.
• Competitive pressure within PAMORAs typically compresses share and net pricing through tiering and rebate demands.
• The decisive long-term market inflection is loss of exclusivity, but precise “when” and “what generic entry scenario” cannot be stated from the information provided in this prompt.
• The company’s financial trajectory is therefore most sensitive to contracting outcomes and patient conversion/persistence, with future downside tied to patent and regulatory expiry execution.

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FAQs

1. Is SKYCLARYS used for constipation beyond opioid-induced constipation?
2. What typical prior authorization requirements affect SKYCLARYS coverage in commercial plans?
3. How do PAMORA class competitors influence SKYCLARYS net price through rebate negotiations?
4. Does SKYCLARYS adoption depend more on prescriber specialty or primary care management of OIC?
5. What market events most often drive branded OIC revenue declines: tier downgrades or generic launches?

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References

1. FDA Orange Book (Drug Products@FDA): opioid-induced constipation therapies listing pages.
2. FDA labeling and approval history for naldemedine (SKYCLARYS).
3. Public company filings and investor materials for SKYCLARYS marketing entities (annual reports, quarterly earnings releases).