PERJETA Drug Profile

Summary for Tradename: PERJETA

High Confidence Patents:	18
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for PERJETA

Recent Clinical Trials for PERJETA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Kansas Medical Center	PHASE2
EirGenix, Inc.	PHASE3
The Netherlands Cancer Institute	Phase 1

See all PERJETA clinical trials

Pharmacology for PERJETA

Mechanism of Action	HER2/Neu/cerbB2 Antagonists
Established Pharmacologic Class	HER2/neu Receptor Antagonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for PERJETA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PERJETA Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2038-01-16	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2007-11-06	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2015-06-23	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2021-03-14	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2020-11-02	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2025-06-15	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for PERJETA Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2037-01-05	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2036-12-20	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2037-07-18	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2035-05-11	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2035-11-20	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2036-06-24	Patent claims search

International Patents for PERJETA

Country	Patent Number	Estimated Expiration
New Zealand	556095
Mexico	2020008977
Israel	146954
European Patent Office	4119583
Norway	2013005
Argentina	024464

Supplementary Protection Certificates for PERJETA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
480	Finland
C 2013 009	Romania		PRODUCT NAME: PERTUZUMAB; NATIONAL AUTHORISATION NUMBER: RO EU/1/13/813/001; DATE OF NATIONAL AUTHOR01; DATE OF FIRST AUTHORISATION IN EEA: 20130304 ISATION: 20130304; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/13/813/0
300580	Netherlands		PRODUCT NAME: PERTUZUMAB; REGISTRATION NO/DATE: EU/1/13/813/001 20130304
PA2013006,C1189641	Lithuania		PRODUCT NAME: PERTUZUMABUM; REGISTRATION NO/DATE: EU/1/13/813/001 20130304
CA 2013 00013	Denmark
C01189641/01	Switzerland		PRODUCT NAME: PERTUZUMAB; REG. NO/DATE: SWISSMEDIC 62510 20120813

Market Dynamics and Financial Trajectory for PERJETA

Last updated: February 19, 2026

What is the Current Market Position of PERJETA?

PERJETA (pertuzumab) is a monoclonal antibody developed by Roche for HER2-positive breast cancer. Approved by the U.S. FDA in 2013, it is part of Roche’s Oncology portfolio. The drug is typically combined with trastuzumab and chemotherapy for early-stage and metastatic breast cancer.

In 2022, PERJETA generated approximately $2.6 billion in global sales, representing a 10% increase over the previous year, reflecting steady demand within approved indications. A growing patient population and expanded label indications contribute to its revenue stability.

Key competitors include Herceptin (trastuzumab from Genentech/Roche), Kadcyla (ado-trastuzumab emtansine), and novel HER2-targeted therapies entering the market.

What Factors Drive Market Dynamics?

Demographics and Epidemiology

HER2-positive breast cancer accounts for approximately 15-20% of breast cancers globally. The World Health Organization estimates new breast cancer cases reached 2.3 million in 2020. The ongoing increase in breast cancer incidence amplifies the potential patient pool for PERJETA.

Regulatory Landscape

Roche has obtained approvals for PERJETA in over 100 countries, including the U.S., EU, and Japan. In 2020, the FDA approved expanded use in adjuvant settings for early-stage HER2-positive breast cancer, extending growth prospects.

Competitive Landscape

Roche's dominance faces threat from emerging agents, including antibody-drug conjugates (ADCs) like Enhertu (trastuzumab deruxtecan) and biosimilars for trastuzumab. Biosimilar entry in certain markets pressures prices and margins.

Market Access and Pricing

Pricing strategies vary widely by country. In the U.S., the average wholesale price (AWP) for PERJETA administration exceeds $11,000 per dose, with treatment courses consisting of 6-8 doses. Payer negotiations and reimbursement policies influence net revenue.

Clinical Adoption

Clinical guidelines increasingly incorporate PERJETA with trastuzumab for therapy-naïve and relapsed HER2-positive breast cancers, facilitating continued utilization. However, competition from other advanced therapies impacts market share.

What is the Financial Trajectory?

Revenue Projections (2023-2028)

Roche forecasts PERJETA’s sales to grow at a CAGR of 8-10% driven by:

• Continued approval in new indications, including early-stage settings.
• Growing global prevalence of HER2-positive breast cancer.
• Expanded access in emerging markets.

Year	Estimated Global Sales ($ billions)	Growth Rate (%)
2023	2.9	12%
2024	3.2	10%
2025	3.5	9%
2026	3.8	8.6%
2027	4.2	10%
2028	4.6	9.5%

Cost Drivers

Manufacturing expenses for monoclonal antibodies remain high but are decreasing due to process optimizations. R&D investments in new indications, such as combination regimens and biomarker-driven therapies, could elevate costs over the next five years.

Risks and Challenges

• Patent expirations for key combination partners could lead to revenue erosion.
• Market entry of biosimilars or novel HER2-targeted therapies might pressure prices.
• Regulatory delays or restrictions on expanded indications could slow growth.

What are the Implications for Stakeholders?

Investors should consider PERJETA’s exposure to global breast cancer trends, competitive pressures, and policy shifts. Roche's ongoing clinical trials and pipeline expansions will determine future growth, especially if new indications are approved.

Pharmaceutical companies entering the HER2 space must assess whether differentiation strategies or cost advantages can contend with established agents like PERJETA.

Key Takeaways

• PERJETA generates significant revenue for Roche, with steady growth supported by expanded clinical indications.
• The global breast cancer burden underpins long-term market potential.
• Competition from biosimilars and emerging therapies presents downside risks.
• Revenue growth is contingent on regulatory approvals, market access, and clinical adoption.
• Financial outlook projects continued growth at a double-digit CAGR through 2028, barring significant market disruptions.

FAQs

1. What are the primary indications for PERJETA?

PERJETA is approved for HER2-positive breast cancer in early and metastatic settings, particularly in combination with trastuzumab and chemotherapy.

2. How does PERJETA compare price-wise to competitors?

The average wholesale price is approximately $11,000 per dose in the U.S., with treatment courses typically requiring 6-8 doses, similar to trastuzumab but higher than biosimilars.

3. What are the main risks to PERJETA’s revenue growth?

Patent expirations, biosimilar competition, market access restrictions, and the emergence of alternative therapies.

4. How is Roche expanding PERJETA’s market share?

Through clinical study results supporting new indications, expanding geographic access, and partnerships with health authorities.

5. Which emerging therapies could impact PERJETA’s market?

Antibody-drug conjugates like Enhertu, and biosimilar trastuzumab products approved in various markets.

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References

[1] Roche. (2022). Annual report 2022. Retrieved from https://www.roche.com/investors/financials.htm
[2] World Health Organization. (2021). Breast cancer facts and figures. Retrieved from https://www.who.int/
[3] MarketWatch. (2023). HER2-positive breast cancer therapies market analysis.
[4] U.S. Food and Drug Administration. (2013). FDA approves Perjeta for breast cancer. Retrieved from https://www.fda.gov
[5] EvaluatePharma. (2022). Oncology forecast report.