TRIKAFTA (COPACKAGED) Drug Patent Profile

Which patents cover Trikafta (copackaged), and when can generic versions of Trikafta (copackaged) launch?

Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are thirty-two patents protecting this drug.

This drug has five hundred and fifteen patent family members in forty-seven countries.

The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. One supplier is listed for this compound. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.

DrugPatentWatch^® Generic Entry Outlook for Trikafta (copackaged)

Trikafta (copackaged) was eligible for patent challenges on October 21, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2037. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 TRIKAFTA (COPACKAGED)

International Patents:	515
US Patents:	32
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIKAFTA (COPACKAGED)
DailyMed Link:	TRIKAFTA (COPACKAGED) at DailyMed

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

NDA:

212273

Dosage:

TABLET, TABLET;ORAL

NDA:

217660

Dosage:

GRANULES;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 TRIKAFTA (COPACKAGED)

TRIKAFTA (COPACKAGED) is protected by eighty-six US patents and five 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	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y	Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No			Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y	Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No

International Patents for TRIKAFTA (COPACKAGED)

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

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 TRIKAFTA (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2021512117	嚢胞性線維症を処置するための医薬組成物
European Patent Office	2489659	Modulateurs de transporteurs de cassette de liaison a l ́ATP (Modulators of ATP-binding cassette transporters)
Colombia	2019007129
European Patent Office	3708564	UNE FORME SOLIDE DE N-[2,4-BIS(1,1-DIMÉTHYLÉTHYL)-5-HYDROXYPHÉNYL]-1,4-DIHYDRO-4-OXOQUINOLINE-3-CARBOXAMIDE (A SOLID FORM OF N-[2,4-BIS(1,1-DIMETHYLETHYL)-5-HYDROXYPHENYL]-1,4-DIHYDRO-4-OXOQUINOLINE-3-CARBOXAMIDE)
Denmark	3219705

Supplementary Protection Certificates for TRIKAFTA (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2826776	132021000000062	Italy		PRODUCT NAME: UNA COMBINAZIONE DI (A) TEZACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E (B) IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SYMKEVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1306, 20181106
1773816	2015/036	Ireland		PRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
1773816	300748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
2826776	PA2021508	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 JO FARMACISKAI PRIIMTINOS DRUSKOS IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/18/1306 20181031
1773816	237 5014-2015	Slovakia		PRODUCT NAME: N-(5-HYDROXY-2,4-DITERC-BUTYL-FENYL)-4-OXO- -1H-CHINOLIN-3-KARBOXAMID (IVACAFTOR); REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120725

Market Dynamics and Financial Trajectory for TRIKAFTA (COPACKAGED)

Introduction

TRIKAFTA (COPACKAGED), a groundbreaking drug developed by Vertex Pharmaceuticals, has revolutionized the treatment of cystic fibrosis (CF), a genetic disorder that severely affects the lungs and digestive system. This article delves into the market dynamics and financial trajectory of TRIKAFTA, highlighting its impact, sales performance, and future outlook.

Approval and Launch

TRIKAFTA received approval in the U.S. in late October 2019 and shortly thereafter in Europe. This swift approval was a significant milestone, marking a new era in CF treatment by enabling the drug to be used by approximately 90% of the patient population, including those with the most common F508del mutation and other responsive mutations[3].

Initial Sales and Market Impact

The launch of TRIKAFTA was nothing short of phenomenal. Within just 10 weeks of its market entry, the drug generated $420 million in revenue, making it the best launch for Vertex and the second biggest drug launch in the past five years, following Gilead's hepatitis C medicine Harvoni. By the first quarter of 2020, TRIKAFTA's sales had surged to $895 million, nearly 90% higher than analyst estimates[3].

Financial Performance

The success of TRIKAFTA has been a major driver of Vertex's financial growth. In the first quarter of 2023, Vertex reported product revenue of $2.37 billion, a 13% increase compared to the same period in 2022. TRIKAFTA/KAFTRIO, the international version of TRIKAFTA, contributed significantly to this growth, with revenues of $2.096 billion[2].

Quarterly and Annual Revenue

• First Quarter 2023: $2.37 billion in product revenue, with TRIKAFTA/KAFTRIO accounting for $2.096 billion[2].
• Full-Year 2023 Guidance: Vertex expects product revenue to range between $9.55 billion and $9.7 billion[2].

Market Penetration and Patient Uptake

TRIKAFTA's rapid uptake has been driven by its efficacy and the broad patient population it can treat. The drug has shown clinically meaningful improvements in lung function, nutritional status, pulmonary exacerbations, and quality of life for CF patients. However, as the majority of eligible U.S. patients (around 18,000) have already initiated treatment, the growth curve has begun to flatten[3].

Patient Compliance and Persistence

Patient compliance and persistence with the treatment are crucial for maintaining sales momentum. Vertex executives have emphasized that these factors will increasingly impact the drug's performance as the initial high compliance rates level out over time[3].

Competitive Landscape

The introduction of TRIKAFTA has significantly altered the competitive landscape in the CF treatment market. While it has led to a decline in sales for other Vertex CF products like Kalydeco, Orkambi, and Symdeko, TRIKAFTA has expanded Vertex's market share and dominance in the CF treatment sector[3].

Regulatory and Patent Protection

TRIKAFTA is protected by a robust patent portfolio, including 32 U.S. patents and 504 international patent family members across 45 countries. The earliest date for generic entry is estimated to be December 8, 2037, although this could change due to patent challenges or generic licensing agreements[1].

Health Economic Considerations

Despite its clinical benefits, TRIKAFTA faces challenges related to its high cost. Health economic assessments have indicated that the drug is not cost-effective at its current public list price. For instance, the Canadian Agency for Drugs and Technologies in Health (CADTH) has recommended reimbursement only if the price is reduced, citing an incremental cost-effectiveness ratio (ICER) of $1,122,823 per quality-adjusted life-year (QALY)[4].

Future Outlook

The future of TRIKAFTA is promising but comes with some challenges. Vertex is working to expand the drug's use to younger patients, having recently received approval for children aged 2 to 5 years. However, the company must navigate the impact of COVID-19 on clinical trials and patient compliance, as well as address the high cost and associated health economic concerns[2][3].

Expansion into New Patient Populations

Vertex continues to advance its pipeline, including plans to treat younger patients and those with rare CFTR mutations. This expansion is expected to sustain the drug's market presence and growth potential[2].

Addressing Cost and Access Issues

To ensure broader access, Vertex may need to negotiate price reductions or explore alternative pricing models. This could involve discussions with health authorities and payers to make the drug more affordable and thus more widely available[4].

Key Takeaways

• Rapid Market Uptake: TRIKAFTA has seen unprecedented sales growth since its launch.
• Financial Impact: The drug has significantly contributed to Vertex's revenue, with $2.096 billion in revenue for the first quarter of 2023.
• Patient Compliance: Maintaining patient compliance and persistence is crucial for sustained sales.
• Regulatory Protection: TRIKAFTA is protected by a robust patent portfolio until at least 2037.
• Health Economic Challenges: The drug's high cost poses challenges for reimbursement and access.

FAQs

What is the current market performance of TRIKAFTA?

TRIKAFTA has shown exceptional market performance, with revenues of $2.096 billion in the first quarter of 2023, driving a 13% increase in Vertex's product revenue compared to the same period in 2022[2].

How does TRIKAFTA impact other Vertex CF products?

The launch of TRIKAFTA has led to a decline in sales for other Vertex CF products like Kalydeco, Orkambi, and Symdeko, as many patients have switched to TRIKAFTA[3].

What are the health economic concerns surrounding TRIKAFTA?

TRIKAFTA is not considered cost-effective at its current public list price, with an ICER of $1,122,823 per QALY. A price reduction is necessary for it to be deemed cost-effective[4].

When is the earliest date for generic entry of TRIKAFTA?

The earliest date for generic entry of TRIKAFTA is estimated to be December 8, 2037, subject to changes due to patent challenges or generic licensing agreements[1].

How is Vertex addressing the high cost of TRIKAFTA?

Vertex is likely to engage in discussions with health authorities and payers to negotiate price reductions or explore alternative pricing models to make the drug more accessible[4].

Sources

1. DrugPatentWatch, "TRIKAFTA (COPACKAGED)".
2. Vertex Pharmaceuticals, "Vertex Reports First Quarter 2023 Financial Results".
3. Biopharma Dive, "Vertex's drug launch hits new heights, but further growth could be challenging".
4. CADTH, "Elexacaftor-Tezacaftor-Ivacaftor and Ivacaftor (Trikafta)".
5. Canadian Journal of Health Technology Assessment, "Elexacaftor-Tezacaftor-Ivacaftor and Ivacaftor (Trikafta)".