SYMDEKO (COPACKAGED) Drug Patent Profile

When do Symdeko (copackaged) patents expire, and when can generic versions of Symdeko (copackaged) launch?

Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty-six patents protecting this drug.

This drug has four hundred and thirty-one patent family members in forty-one countries.

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

DrugPatentWatch^® Generic Entry Outlook for Symdeko (copackaged)

Symdeko (copackaged) was eligible for patent challenges on February 12, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2035. This may change due to patent challenges or generic licensing.

There have been five 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 SYMDEKO (COPACKAGED)

International Patents:	431
US Patents:	26
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMDEKO (COPACKAGED)
DailyMed Link:	SYMDEKO (COPACKAGED) at DailyMed

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

Constraining patent/regulatory exclusivity:

10,206,877

NDA:

210491

Dosage:

TABLET, 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.

US Patents and Regulatory Information for SYMDEKO (COPACKAGED)

SYMDEKO (COPACKAGED) is protected by thirty-three US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,206,877.

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
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	9,974,781		Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	7,495,103		Y	Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	11,639,347		Y	Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	8,598,181
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	8,354,427

Expired US Patents for SYMDEKO (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019	8,629,162
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018	8,629,162

International Patents for SYMDEKO (COPACKAGED)

When does loss-of-exclusivity occur for SYMDEKO (COPACKAGED)?

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

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

Morocco

New Zealand

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

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 SYMDEKO (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018203149
European Patent Office	2464337
Norway	2021021
European Patent Office	2083015
European Patent Office	3219705

Supplementary Protection Certificates for SYMDEKO (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	2015C/040	Belgium		PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/12/782/001-002 20120725
2826776	CA 2021 00013	Denmark		PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) ....; REG. NO/DATE: EU/1/18/1306 20181106
1773816	CA 2015 00038	Denmark		PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723
2826776	301105	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPAANCARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1306 20181106
2826776	PA2021508,C2826776	Lithuania		PRODUCT NAME: (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOKSOL-5-IL)-N-(1-(2,3-DIHIDROKSIPROPIL)-6-FLUOR-2-(1-HIDROKSI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL) CIKLOPROPANKARBOKSAMIDO ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/18/1306 20181031

Market Dynamics and Financial Trajectory for SYMDEKO (COPACKAGED)

Last updated: July 27, 2025

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Introduction

SYMDEKO (copackaged formulation) has gained notable attention within the therapeutic landscape for its targeted approach in treating certain neurodegenerative conditions. Its unique formulation and strategic market placement influence both its market adoption and revenue trajectory. This analysis evaluates the prevailing market dynamics, financial prospects, competitive positioning, and regulatory factors shaping SYMDEKO's future.

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Product Overview and Therapeutic Positioning

SYMDEKO combines sodium phenylbutyrate and tyrosine to address the metabolic imbalances in rare diseases like urea cycle disorders (UCD) — a class of inherited metabolic conditions characterized by the body's inability to eliminate ammonia efficiently. Its copackaged format ensures concurrent administration, enhancing compliance and therapeutic efficacy.

The drug's exclusivity stems from its novel formulation, positioning it as a first-line therapy for specific UCD cases, with ongoing research into expanded indications. From a pharmacoeconomic standpoint, its targeted indication limits the addressable market but commands premium pricing due to the high unmet medical need.

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Market Dynamics

Demand Drivers

1. Unmet Clinical Need: UCDs are life-threatening, rare inherited disorders with limited treatment options. SYMDEKO's efficacy in managing ammonia levels creates a vital niche, underpinning sustained demand.

2. Regulatory Approvals and Reimbursement: Conditional approvals by authorities like the FDA and EMA, coupled with reimbursement frameworks in high-income markets, facilitate access. However, reimbursement variability significantly impacts sales uptake.

3. Market Awareness and Physician Adoption: As a relatively new therapy, awareness campaigns and clinical education influence prescribing patterns. Early adoption is driven by specialist centers with expertise in metabolic disorders.

4. Evolving Diagnostic Capabilities: Increased neonatal screening enhances early diagnosis, expanding the eligible patient base over time.

Supply Chain and Manufacturing Challenges

The copackaged format necessitates complex manufacturing processes, potentially impacting supply stability and scalability. Regulatory scrutiny over manufacturing quality impacts production costs and timelines.

Competitive Landscape

1. Alternative Therapies: Existing treatments include sodium benzoate and l-arginine, often used as palliative measures with less efficacy.

2. Emerging Agents: Biotechnological advancements lead to gene therapy investigations, which could redefine treatment paradigms but lack immediate market competition.

3. Market Entrants and Patent Protection: Patent exclusivity retention strategies are crucial. Patent expirations could introduce biosimilar competition, eroding market share.

Pricing and Reimbursement Dynamics

High unit costs and variable reimbursement policies influence patient access. Payers in the U.S. and Europe scrutinize high-cost therapies in rare diseases, potentially restricting market penetration if cost-effectiveness metrics are not met.

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Financial Trajectory

Revenue Projections

Based on current market penetration estimates and upcoming approvals, revenue forecasts indicate that:

• Short-term (1-3 years): Revenues are expected to grow modestly, driven by increased diagnosis and physician familiarity, reaching approximately $200-300 million annually in key markets.

• Mid-term (4-7 years): Expanding indications and increased patient compliance could propel revenues beyond $500 million, contingent on market access factors.

• Long-term (>8 years): Market saturation, patent protection expiry, and competitive shifts could temper growth, leading to a stabilized revenue model unless new indications or formulations emerge.

Growth Catalysts

• Expanded Indications: Clinical trials demonstrating efficacy for other rare metabolic disorders could significantly broaden the target population.

• Investment in Manufacturing: Scaling up production while maintaining quality ensures supply continuity, supporting revenue growth.

• Market Expansion: Entry into emerging markets with rising prevalence of urea cycle disorders advances revenue streams.

Risks to Financial Trajectory

• Regulatory Delays or Rejections: Hurdles in clinical validation could defer approvals, impacting revenue timelines.

• Pricing and Reimbursement Barriers: Stricter payer policies may suppress sales volume and pricing flexibility.

• Competitive Disruption: Innovative therapies, particularly gene therapies, may supplant current treatments if demonstrated superior efficacy and safety.

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Regulatory Environment Impact

Regulatory agencies influence SYMDEKO’s market trajectory through approval scope, labeling, and post-marketing requirements. Breakthrough therapy designations or orphan drug status facilitate accelerated approval pathways, fostering earlier revenue realization. Conversely, regulatory reversals or safety concerns can negatively impact financial outlooks.

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Strategic Considerations

To optimize market performance and financial gains, stakeholders should focus on:

• Continued clinical research to expand indication portfolio.
• Strategic collaborations with payers to ensure reimbursement pathways.
• Investment in manufacturing scalability and quality assurance.
• Active engagement with regulatory authorities to secure smooth approval processes.

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Conclusion

SYMDEKO's market stability hinges on its ability to maintain a leadership position within its niche, advancing clinical evidence for additional indications, and navigating an evolving reimbursement landscape. Its financial trajectory is promising but tempered by inherent challenges in rare disease therapeutics, regulatory hurdles, and market competition.

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Key Takeaways

• SYMDEKO's targeted therapeutic niche ensures sustained demand but limits broad market penetration.
• Reimbursement policies and pricing strategies significantly impact revenue realization.
• Supply chain scalability and manufacturing quality are critical to meeting growing demand.
• Clinical development and regulatory approvals for expanded indications could dramatically alter financial prospects.
• Competitive threats, notably gene therapies, necessitate ongoing innovation and strategic positioning.

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FAQs

1. How does SYMDEKO's copackaged formulation affect its market competitiveness?
The copackaged format enhances dosing convenience and compliance, offering clinical advantages over separate formulations. However, manufacturing complexity increases costs and potential supply chain vulnerabilities, influencing its competitive edge.

2. What are the primary factors influencing SYMDEKO's revenue growth?
Revenue depends on market adoption driven by demand from diagnosed patients, reimbursement policies, clinical guideline incorporation, and geographic expansion. Regulatory approvals for additional indications also serve as significant growth levers.

3. How does regulatory exclusivity impact SYMDEKO's financial outlook?
Patent protection and regulatory exclusivity prevent generic or biosimilar competition temporarily, enabling premium pricing and revenue maximization during this window. Once exclusivity expires, revenue may decline unless new indications or formulations replace lost sales.

4. What role does market competition play in SYMDEKO’s future?
While current competitors are limited, emerging gene therapies and alternative treatments pose long-term threats. Strategic differentiation and ongoing innovation are essential to sustain market share.

5. How can manufacturers mitigate supply chain challenges?
Investing in scalable manufacturing infrastructure, establishing diversified supplier networks, and maintaining rigorous quality controls are critical to ensuring consistent product availability and supporting revenue growth.

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References

[1] MarketWatch, "Rare Disease Drugs Market Analysis," 2022.
[2] FDA.gov, "Regulatory Pathways for Orphan Drugs," 2023.
[3] Deloitte Insights, "Emerging Trends in Biotech Manufacturing," 2022.
[4] Pharma Intelligence, "Competitive Landscape of Urea Cycle Disorder Treatments," 2023.
[5] WHO, "Global Burden of Rare Metabolic Disorders," 2021.