TUCATINIB - Generic Drug Details

What are the generic sources for tucatinib and what is the scope of freedom to operate?

Tucatinib is the generic ingredient in one branded drug marketed by Seagen and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tucatinib has two hundred and eighteen patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for TUCATINIB

International Patents:	218
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	52
Patent Applications:	291
What excipients (inactive ingredients) are in TUCATINIB?	TUCATINIB excipients list
DailyMed Link:	TUCATINIB at DailyMed

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

Constraining patent/regulatory exclusivity:

9,457,093

Dosage:

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.

Recent Clinical Trials for TUCATINIB

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

Sponsor	Phase
RemeGen Co., Ltd.	Phase 1/Phase 2
Jonathan Riess	Phase 1
National Cancer Institute (NCI)	Phase 1

See all TUCATINIB clinical trials

Pharmacology for TUCATINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TUCATINIB

L01EH	Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TUCATINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	9,457,093		Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes	8,648,087		Y	Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	7,452,895		Y	Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	12,048,698
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No

Expired US Patents for TUCATINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020	7,452,895
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020	7,452,895

EU/EMA Drug Approvals for TUCATINIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Seagen B.V.	Tukysa	tucatinib	EMEA/H/C/005263 Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑HER2 treatment regimens.	Authorised	no	no	no	2021-02-11

International Patents for TUCATINIB

Country	Patent Number	Title	Estimated Expiration
Israel	232103	דיספרסיה מוצקה המכילה 4n-)4-([4.2.1]טריאזולו[a5,1]פירידין-7-אילאוקסי-3-מתילפניל)-n6 - (4,4-דימתיל-5,4-דיהידרוקסואוקסאזול-2-איל)קיוונאזולין-6,4-דיאמין ופולימר מבדר, תהליך להכנתה ותכשיר רוקחות המכיל אותה (Solid dispersions of a erb2 (her2) inhibitor)
Colombia	6960547	Dispersión sólida de un inhibidor erb2 (her2)
New Zealand	545459	Quinazoline analogs as receptor tyrosine kinase inhibitors
New Zealand	724544	Treatment of brain cancer
Australia	2021261849	TREATMENT OF BRAIN CANCER
South Korea	20060064630	QUINAZOLINE ANALOGS AS RECEPTOR TYROSINE KINASE INHIBITORS
Mexico	2014004551	DISPERSION SOLIDA. (SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR.)

Supplementary Protection Certificates for TUCATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1971601	C202130042	Spain		PRODUCT NAME: TUCATINIB, OPCIONALMENTE EN FORMA DE UNA SAL O SOLVATO ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/20/1526; DATE OF AUTHORISATION: 20210211; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1526; DATE OF FIRST AUTHORISATION IN EEA: 20210211
1971601	PA2021516	Lithuania		PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211
1971601	LUC00217	Luxembourg		PRODUCT NAME: TUCATINIB EVENTUELLEMENT SOUS FORME D'UN SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/20/1526 20210212
1971601	CA 2021 00025	Denmark		PRODUCT NAME: TUCATINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; NAT. REG. NO/DATE: EU/1/20/1526 20210212; FIRST REG. NO/DATE: CH 67798 20200507
1971601	2190026-1	Sweden		PRODUCT NAME: TUCATINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; NAT. REG. NO/DATE: EU/20/1526 20210212; FIRST REG.: CH 67798 20200507
1971601	132021000000128	Italy		PRODUCT NAME: TUCATINIB OPZIONALMENTE NELLA FORMA DI UN SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(TUKYSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1526, 20210212
1971601	C 2021 022	Romania		PRODUCT NAME: TUCATINIB OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC SAU SOLVAT; NATIONAL AUTHORISATION NUMBER: EU/1/20/1526; DATE OF NATIONAL AUTHORISATION: 20210211; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1526; DATE OF FIRST AUTHORISATION IN EEA: 20210211

TUCATINIB Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Tucatinib

Introduction

Tucatinib, marketed as Tukysa, is a significant player in the oncology market, particularly in the treatment of HER2-positive cancers. Developed by Seagen Inc., this oral HER2 inhibitor has shown promising results in various clinical trials and real-world studies. Here, we delve into the market dynamics and financial trajectory of tucatinib, highlighting its performance, challenges, and future prospects.

Approval and Indications

Tucatinib has received several approvals from regulatory bodies, including the FDA. Initially approved in April 2020 for the treatment of previously treated HER2-positive metastatic breast cancer in combination with trastuzumab and capecitabine, tucatinib has since expanded its indications. In January 2023, it received accelerated approval for the treatment of HER2-positive unresectable or metastatic colorectal cancer in combination with trastuzumab[4].

Market Performance

Sales and Revenue

In 2021, tucatinib generated $334 million in net sales, nearly triple the amount from 2020. However, Seagen's outlook for tucatinib's sales in 2022 was cautious, predicting flat or falling net sales due to increasing competition, particularly from Enhertu, a rival therapy by AstraZeneca[1].

Competitive Landscape

The breast cancer treatment market is highly competitive, with Enhertu emerging as a significant competitor. Enhertu's impressive clinical results and potential for broader label approval have led analysts to predict truncated use of tucatinib in second-line settings, especially in patients without brain metastases[1].

Clinical Efficacy and Real-World Data

HER2CLIMB Trial

The HER2CLIMB trial demonstrated tucatinib's efficacy in combination with trastuzumab and capecitabine, showing a median overall survival of 21.9 months and progression-free survival of 7.8 months in patients with HER2-positive metastatic breast cancer[2].

Real-World Studies

Real-world data from a large retrospective analysis indicate that tucatinib-based treatment exhibits durable effectiveness across multiple lines of therapy and in the presence and absence of brain metastasis. The study showed a median time to next treatment (TTNT) of 10.7 months and a median time to discontinuation (TTD) of 8.5 months[2].

HER2CLIMB-02 Trial

The phase III HER2CLIMB-02 trial further reinforced tucatinib's benefits when combined with trastuzumab emtansine (T-DM1), reducing the risk of disease progression or death by 24.1% compared to the placebo arm. For patients with brain metastases, this reduction was even more significant, at 36.1%[5].

Financial Impact and Investor Sentiment

Market Value and Stock Performance

Seagen's stock price dipped significantly following the earnings report that highlighted the cautious sales outlook for tucatinib. The company lost roughly $4 billion in market value, with its stock price falling as much as 17% in a single trading session[1].

Revenue Growth and Projections

Despite the challenges, Seagen reported a 38% annual increase in net sales from its four marketed drugs, reaching almost $1.4 billion in 2021. However, the forecast for tucatinib's sales in 2022 was more conservative, with predictions ranging from $315 million to $335 million[1].

Strategic Initiatives to Offset Challenges

Label Expansion

Seagen is working to expand tucatinib's label to mitigate the impact of competition. For example, a study evaluating tucatinib in combination with trastuzumab is expected to report data by the end of May, which could lead to additional approvals and increased market share[1].

Regulatory Approvals and Designations

Tucatinib has been granted priority review, breakthrough therapy designation, and orphan drug designation for the treatment of HER2-positive colorectal cancer. These designations expedite the regulatory process and highlight the drug's potential in addressing unmet medical needs[4].

Future Prospects

Expanding Indications

The recent approval for HER2-positive colorectal cancer and ongoing trials suggest that tucatinib's market potential extends beyond breast cancer. This expansion could help offset the competitive pressures in the breast cancer market[4].

Global Reach and Collaboration

Tucatinib's approval under Project Orbis, an initiative for concurrent submission and review of oncology drugs among international partners, facilitates its global availability. This collaboration with regulatory agencies like the Australian Therapeutic Goods Administration (TGA) is crucial for its international market penetration[4].

Key Takeaways

• Approval and Indications: Tucatinib has received FDA approvals for HER2-positive metastatic breast cancer and colorectal cancer.
• Market Performance: Despite initial growth, tucatinib faces competition from Enhertu, leading to cautious sales projections.
• Clinical Efficacy: Tucatinib has shown durable effectiveness in clinical trials and real-world studies.
• Financial Impact: Seagen's stock price has been affected by the competitive landscape, but the company continues to see overall revenue growth.
• Strategic Initiatives: Efforts to expand tucatinib's label and regulatory designations are underway to enhance its market position.

FAQs

What is tucatinib, and how is it used?

Tucatinib, marketed as Tukysa, is an oral HER2 inhibitor used in combination with other therapies to treat HER2-positive metastatic breast cancer and colorectal cancer.

What are the key challenges facing tucatinib in the market?

The primary challenge is the increasing competition from other therapies, particularly Enhertu, which has shown impressive clinical results and is expected to gain broader approval.

How has tucatinib performed in clinical trials?

Tucatinib has demonstrated significant efficacy in clinical trials such as the HER2CLIMB and HER2CLIMB-02 trials, showing improved overall survival and progression-free survival in patients with HER2-positive cancers.

What are the future prospects for tucatinib?

Tucatinib's future prospects include expanding its indications beyond breast cancer, such as its recent approval for HER2-positive colorectal cancer, and potential global market penetration through regulatory collaborations.

How has the financial performance of Seagen been affected by tucatinib's sales outlook?

Seagen's stock price has been negatively impacted by the cautious sales outlook for tucatinib, despite the company's overall revenue growth from its portfolio of drugs.

Sources

1. Biopharma Dive: Seagen shares sink as sales outlook of cancer drug disappoints.
2. Journal of Hematology and Oncology Pharmacy: Prolonged Effectiveness With Tucatinib Plus Trastuzumab and Capecitabine in HER2-positive Metastatic Breast Cancer.
3. Pfizer Oncology Innovation Day Presentation: Pfizer-Oncology-Innovation-Day-Presentation_FINAL.pdf.
4. FDA: FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer.
5. American Association for Cancer Research: Tucatinib Plus Trastuzumab Emtansine May Benefit Patients With Advanced or Metastatic HER2-positive Breast Cancer.