SYMDEKO (COPACKAGED) Drug Patent Profile

Which patents cover Symdeko (copackaged), and what generic alternatives are available?

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

This drug has four hundred and twenty-eight 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.

Indicators of Generic Entry

Summary for SYMDEKO (COPACKAGED)

International Patents:	428
US Patents:	25
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	SYMDEKO (COPACKAGED) at DailyMed

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

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-two US patents and three FDA Regulatory Exclusivities.

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			Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes			Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes			Y

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

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
Hungary	E032813
European Patent Office	2502914	Modulateurs de transporteurs de cassette de liaison à l ́ATP (Modulators of ATP-binding cassette transporters)
Mexico	341797	MODULADORES DE TRANSPORTADORES CON CASETE DE UNION CON ATP. (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS.)
Japan	2015172087	ＡＴＰ結合カセットトランスポーターのモジュレーター (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS)
San Marino	T201800074
Portugal	3925607

Supplementary Protection Certificates for SYMDEKO (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	PA2015028,C1773816	Lithuania		PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
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
1773816	617	Finland
1773816	92761	Luxembourg		PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725
2826776	122021000025	Germany		PRODUCT NAME: EINE KOMBINATION VON (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANCARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1306 20181031
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

Market Dynamics and Financial Trajectory for SYMDEKO (COPACKAGED)

Introduction to SYMDEKO

SYMDEKO, a copackaged combination of tezacaftor and ivacaftor, is a groundbreaking treatment for cystic fibrosis (CF) developed by Vertex Pharmaceuticals. This therapy has significantly impacted the lives of patients with CF, particularly those homozygous for the F508del mutation or those with responsive mutations.

Approval and Regulatory Landscape

SYMDEKO was approved by the FDA in February 2018 for patients with CF aged 12 years and older who are F508del homozygous or have at least one mutation responsive to tezacaftor/ivacaftor. This approval was based on the results of two Phase 3 clinical trials that demonstrated statistically significant improvements in lung function and other clinical endpoints[1][2][4].

Clinical Efficacy and Safety

The clinical trials for SYMDEKO showed notable improvements in lung function, measured by the percent predicted forced expiratory volume in one second (ppFEV1). Patients treated with SYMDEKO experienced a mean absolute increase in ppFEV1 compared to placebo across various subgroups. Additionally, the therapy led to reductions in sweat chloride levels and improvements in nutritional status, as indicated by changes in weight and body mass index (BMI)[1][4].

The safety profile of SYMDEKO has been generally favorable, with common adverse reactions including headache, nausea, sinus congestion, and dizziness. Serious adverse reactions were rare, and the overall safety data were consistent across different age groups and subpopulations[2][3].

Market Penetration and Patient Access

SYMDEKO has been commercialized in markets where it has received regulatory approval, with a focus on supporting sales through a specialized commercial organization. Vertex Pharmaceuticals targets a relatively small number of physicians and healthcare professionals who are key prescribers of CF medicines, often located at accredited CF treatment centers[1].

The drug's market penetration is also influenced by reimbursement strategies. Vertex works closely with third-party payors, including governmental organizations, to secure reimbursement for SYMDEKO, ensuring that patients have access to this life-changing therapy[1].

Financial Performance and Revenue

Since its approval, SYMDEKO has contributed significantly to Vertex Pharmaceuticals' revenue. The drug's commercial success is part of the company's broader strategy to develop and commercialize transformative medicines for serious diseases. In the financial reports, SYMDEKO, along with other CF treatments like ORKAMBI and KALYDECO, has been a key driver of revenue growth for Vertex[1].

Revenue Growth

The revenue generated by SYMDEKO has been substantial, reflecting the drug's efficacy and the high demand for effective CF treatments. As more patients become eligible for treatment and as the drug expands into new markets, the revenue trajectory is expected to continue its upward trend.

Cost and Pricing

The pricing of SYMDEKO is a critical factor in its market dynamics. Given its innovative nature and the significant clinical benefits it offers, the drug is priced accordingly. However, Vertex Pharmaceuticals also engages in pricing strategies and reimbursement negotiations to ensure that the drug remains accessible to patients while maintaining a profitable business model[1].

Competitive Landscape

The CF treatment market is highly specialized, with Vertex Pharmaceuticals holding a dominant position due to its portfolio of CFTR-targeted therapies. SYMDEKO competes primarily with other Vertex products, such as ORKAMBI and KALYDECO, although these drugs often serve different patient populations based on their specific genetic mutations.

Market Share

Vertex's strong research and development pipeline and its collaborative efforts with organizations like the Cystic Fibrosis Foundation Therapeutics Incorporated have helped the company maintain a significant market share in the CF treatment space. SYMDEKO's approval and subsequent commercial success have further solidified Vertex's position in this market[1].

Partnerships and Collaborations

Vertex Pharmaceuticals has established several strategic partnerships to advance its research and development efforts. The collaboration with the Cystic Fibrosis Foundation Therapeutics Incorporated is particularly noteworthy, as it has supported the development of SYMDEKO and other CF treatments. These partnerships are crucial for accessing new technologies and drug candidates that can further expand Vertex's pipeline[1].

Future Outlook and Expansion

Pediatric Expansion

SYMDEKO has been approved for patients aged 6 years and older, and ongoing studies are evaluating its safety and efficacy in younger patients. The expansion into pediatric populations is expected to increase the drug's market reach and further improve treatment outcomes for CF patients across different age groups[3].

International Markets

Vertex is actively working to secure approvals and commercialize SYMDEKO in international markets. This global expansion is critical for increasing the drug's revenue potential and ensuring that patients worldwide have access to this effective treatment[1].

Pipeline Development

Vertex continues to invest in scientific innovation, with a focus on developing new therapies for CF and other serious diseases. The company's robust research and development pipeline ensures that it remains at the forefront of medical innovation, potentially leading to new market opportunities and revenue streams[1].

Key Takeaways

• Clinical Efficacy: SYMDEKO has demonstrated significant improvements in lung function and other clinical endpoints for CF patients.
• Market Penetration: The drug is commercialized through a specialized sales and marketing strategy targeting key prescribers.
• Financial Performance: SYMDEKO has been a major contributor to Vertex Pharmaceuticals' revenue growth.
• Competitive Landscape: Vertex dominates the CF treatment market with its portfolio of CFTR-targeted therapies.
• Future Outlook: Expansion into pediatric populations and international markets, along with ongoing pipeline development, is expected to drive continued growth.

FAQs

What is SYMDEKO used for?

SYMDEKO is used for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation or have at least one mutation responsive to tezacaftor/ivacaftor.

What are the common side effects of SYMDEKO?

Common side effects include headache, nausea, sinus congestion, and dizziness. Serious adverse reactions are rare but can include distal intestinal obstruction syndrome and transaminase elevations.

How does SYMDEKO improve lung function?

SYMDEKO improves lung function by increasing the percent predicted forced expiratory volume in one second (ppFEV1) and reducing sweat chloride levels, as demonstrated in clinical trials.

Is SYMDEKO approved for pediatric use?

Yes, SYMDEKO is approved for patients aged 6 years and older. Ongoing studies are evaluating its safety and efficacy in younger patients.

What is the financial impact of SYMDEKO on Vertex Pharmaceuticals?

SYMDEKO has been a significant contributor to Vertex Pharmaceuticals' revenue growth since its approval, reflecting its clinical efficacy and market demand.

Sources

1. Vertex Pharmaceuticals Incorporated. Annual Report on Form 10-K, 2018.
2. FDA. SYMDEKO® (tezacaftor/ivacaftor), tablets, 2023.
3. Vertex Pharmaceuticals. Clinical Results for SYMDEKO, 2023.
4. Vertex Pharmaceuticals. Clinical Trials for Age 12 Years and Older, 2023.