VYALEV Drug Patent Profile

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

Vyalev is a drug marketed by Abbvie and is included in one NDA. There are four patents protecting this drug.

This drug has eighty-eight patent family members in thirty-eight countries.

The generic ingredient in VYALEV is foscarbidopa; foslevodopa. One supplier is listed for this compound. Additional details are available on the foscarbidopa; foslevodopa profile page.

DrugPatentWatch^® Generic Entry Outlook for Vyalev

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VYALEV

International Patents:	88
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in VYALEV?	VYALEV excipients list
DailyMed Link:	VYALEV at DailyMed

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

Constraining patent/regulatory exclusivity:

10,730,895

NDA:

216962

Dosage:

SOLUTION;SUBCUTANEOUS

^*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.

US Patents and Regulatory Information for VYALEV

VYALEV is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,730,895.

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
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	12,251,365
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	10,730,895			Y
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	9,446,059		Y	Y
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	10,174,061		Y
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes

International Patents for VYALEV

When does loss-of-exclusivity occur for VYALEV?

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

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

France

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Netherlands

New Zealand

Norway

Philippines

Poland

Portugal

Russian Federation

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

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 VYALEV around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	102389
Australia	2015335941
Australia	2021201414
Australia	2023210650
Australia	2025238004
Brazil	112017008198

Supplementary Protection Certificates for VYALEV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	2023C/510	Belgium		PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: BE660571 20220901
3209302	301224	Netherlands		PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG128752 20221107; FIRST REGISTRATION: AT 141371 20220826
3209302	CA 2023 00015	Denmark		PRODUCT NAME: KOMBINATION AF FOSLEVODOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG FOSCARBIDOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 66549 (DK) 20221205; FIRST REG. NO/DATE: AT 141371 20220826
3209302	LUC00304	Luxembourg		PRODUCT NAME: COMBINAISON DE FOSLEVODOPA ET DE FOSCARBIDOPA, CHACUNE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; MARKETING AUTHORISATION NUMBER AND DATE: 141371, 20220826
3209302	PA2023519	Lithuania		PRODUCT NAME: FOSLEVODOPOS IR FOSKARBIDOPOS KOMPOZICIJA, KURIU KIEKVIENA YRA VISU FORMU SAUGOMA PAGRINDINIO PATENTO; REGISTRATION NO/DATE: AT, 141371 20220825
3209302	122023000043	Germany		PRODUCT NAME: KOMBINATION VON FOSLEVODOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON MIT FOSCARBIDOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON; NAT. REGISTRATION NO/DATE: 7005976.00.00 20230223; FIRST REGISTRATION: OESTERREICH 141371 20220825

VYALEV (sacrosidase) Market Dynamics and Financial Trajectory: Revenue Drivers, Competition Risks, and IP/Regulatory Timelines

Last updated: June 10, 2026

VYALEV is the brand for sacrosidase (congenital sucrase-isomaltase deficiency; CSID), a niche specialty enzyme replacement therapy. Public financials and detailed market-trajectory disclosures for VYALEV are not available in the provided dataset, and no FDA/Orange Book, patent, litigation, or exclusivity timing records were supplied. Without those primary identifiers and filings, a complete, accurate market-and-financial trajectory cannot be produced.

What is VYALEV’s market size and revenue trajectory for sacrosidase?

No verifiable market-size or revenue-trajectory figures are available in the provided inputs.

What patient volume dynamics drive sacrosidase demand?

CSID is rare and treated long term. Demand is typically driven by:

• diagnosis penetration and guideline adoption
• payer coverage and prior authorization patterns
• adherence to chronic enzyme replacement dosing
• competition from alternative management strategies, including dietary restriction and other enzyme or investigational approaches

What revenue metrics typically show up for niche CSID brands?

Common datapoints used in specialty drug financial modeling include:

• annual treated patients
• net sales per patient (invoiced and net of rebates)
• gross to net trend (rebates/discounts)
• channel mix (specialty pharmacy vs. hospital/clinic)
• continuity of therapy and persistence (months on therapy)

No such figures for VYALEV are provided.

What competitive landscape shapes VYALEV pricing power in CSID?

No competitive pricing-power analysis can be generated from the supplied information.

How do sacrosidase competitors affect net pricing?

Key competitive mechanisms in rare-disease enzyme products usually include:

• formulary inclusion or exclusion at large PBMs
• step-therapy rules and “preferred agent” positioning
• contracting and outcomes-based reimbursement (when offered)
• substitution dynamics for competing enzyme products or branded generics (if any)

No competitor roster or payer positioning data for VYALEV is included.

How do FDA status and exclusivity timelines influence VYALEV financial outcomes?

No FDA regulatory status, exclusivity start dates, or Orange Book listing details are provided, so exclusivity-based forecast timing cannot be built.

What is the Orange Book status of VYALEV and sacrosidase?

No Orange Book listing record is provided.

When does VYALEV lose exclusivity for generic or biosimilar entry?

No exclusivity timeline inputs are provided.

What patents protect VYALEV and sacrosidase, and how strong is the estate?

No patent estate identifiers (application/publication numbers, listed patents in FDA Orange Book, claims, or expiration dates) are provided, so strength scoring and challenge risk cannot be computed.

How many patents cover VYALEV formulations and method-of-use?

No patent counts or coverage mapping are provided.

What generic entry risks exist for VYALEV?

No Paragraph IV filings, litigation dockets, or settlement terms are provided.

What patent litigation affects VYALEV’s commercialization and financial trajectory?

No litigation records, Hatch-Waxman cases, or settlement agreements are provided.

Which companies are challenging VYALEV?

No challenger names are supplied.

What settlement agreements exist for VYALEV?

No settlement documents are provided.

What formulations are protected by VYALEV patents?

No formulation, strength, dosage form, or manufacturing patent data is provided.

Are there protected variants (dose strength, packaging, or manufacturing process)?

No such variant patent information is provided.

How does VYALEV compare with other CSID therapies on cost, access, and outcomes?

No head-to-head access or outcomes data is provided.

What delivery and adherence factors matter for sacrosidase?

Sacrosidase products are typically evaluated on:

• dosing frequency and volume
• storage and stability
• ability to mix with food
• administration workflow for caregivers

No VYALEV-specific handling or comparative data is provided.

What manufacturing and IP barriers affect VYALEV generic substitution risk?

No manufacturing process IP, know-how access restrictions, or supply-chain/IP barriers are provided.

Key Takeaways

• VYALEV is a specialty, long-duration therapy in CSID, but no provided inputs include VYALEV financials, market sizing, FDA/Orange Book status, exclusivity timelines, patent listings, or litigation records needed to produce a complete and accurate market dynamics and financial trajectory.
• A full forecast of revenue trajectory and generic entry risk requires regulatory and IP identifiers and financial disclosure inputs that are not present in the provided dataset.

FAQs

1) What is VYALEV used to treat (indication and patient population)?
VYALEV is sacrosidase, used for congenital sucrase-isomaltase deficiency (CSID).

2) Is VYALEV available under FDA Orange Book listings and what does that imply for generics?
No Orange Book listing details were provided.

3) When do sacrosidase patents expire, and when could generics launch?
No patent expiration or exclusivity dates were provided.

4) What Paragraph IV risks exist for VYALEV?
No Paragraph IV filings or challengers were provided.

5) What are typical payer access barriers for rare-disease enzyme therapies like sacrosidase?
Common barriers include prior authorization, step edits, and specialty pharmacy restriction, but VYALEV-specific payer rules were not provided.

References

No sources were provided in the prompt, and no external citations can be reliably constructed from the available information.