EMTRIVA Drug Patent Profile

When do Emtriva patents expire, and what generic alternatives are available?

Emtriva is a drug marketed by Gilead and is included in two NDAs.

The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emtriva

A generic version of EMTRIVA was approved as emtricitabine by CIPLA on July 2^nd, 2018.

Summary for EMTRIVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	13
Patent Applications:	4,622
Drug Prices:	Drug price information for EMTRIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRIVA
What excipients (inactive ingredients) are in EMTRIVA?	EMTRIVA excipients list
DailyMed Link:	EMTRIVA at DailyMed

See drug prices for EMTRIVA

Recent Clinical Trials for EMTRIVA

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

Sponsor	Phase
Butler Hospital	Phase 1
Alzheimer's Association	Phase 1
The Miriam Hospital	Phase 1

See all EMTRIVA clinical trials

Pharmacology for EMTRIVA

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for EMTRIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMTRIVA	Capsules	emtricitabine	200 mg	021500	1	2012-07-16

US Patents and Regulatory Information for EMTRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	AB	RX	Yes	Yes
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005		RX	Yes	Yes

Expired US Patents for EMTRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005	6,642,245*PED
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	6,703,396*PED
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005	5,914,331*PED

EU/EMA Drug Approvals for EMTRIVA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Emtriva	emtricitabine	EMEA/H/C/000533Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.	Authorised	no	no	no	2003-10-24

International Patents for EMTRIVA

See the table below for patents covering EMTRIVA around the world.

Country	Patent Number	Title	Estimated Expiration
China	100396785
Hong Kong	1026419
Canada	2481078	METHODE ET COMPOSITIONS POUR LA SYNTHESE DE BCH-189 ET DE COMPOSES APPARENTES (METHOD AND COMPOSITIONS FOR THE SYNTHESIS OF BCH-189 AND RELATED COMPOUNDS)

Supplementary Protection Certificates for EMTRIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3808743	2290034-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVRINE OR A THERAPEUTICALLY EQIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240	2016/058	Ireland		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; NAT REGISTRATION NO/DATE: EU/1/16/1112 20160621; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2457)
1663240	300851	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EMTRIVA (Trastuzumab Emtansine)

Last updated: July 28, 2025

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Introduction

EMTRIVA, commercially known as trastuzumab emtansine (T-DM1), is an antibody-drug conjugate (ADC) developed by Roche, primarily approved for the treatment of HER2-positive metastatic breast cancer. Since its approval by the FDA in 2013, EMTRIVA has become a significant product within the oncology pharmaceutical landscape. This report offers an in-depth analysis of its market dynamics and financial trajectory, emphasizing trends shaping its commercial performance, competitive positioning, and future growth prospects.

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Market Overview

Therapeutic Context and Market Need

HER2-positive breast cancers account for approximately 15-20% of all breast cancer cases, characterized by overexpression of the human epidermal growth factor receptor 2 (HER2), which correlates with aggressive disease progression and poor prognosis. Prior to EMTRIVA, trastuzumab monotherapy offered survival benefits, but resistance and disease progression prompted the need for more targeted and effective agents.

EMTRIVA combines trastuzumab with the cytotoxic agent emtansine (DM1), delivering a potent, targeted cytotoxic payload directly to HER2-overexpressing cancer cells. This mechanism enhances efficacy while minimizing systemic toxicity. The drug's clinical efficacy, demonstrated in pivotal trials such as EMILIA, established it as a standard-of-care in second-line HER2-positive metastatic breast cancer.

Market Penetration and Current Sales

Since launch, EMTRIVA has captured a substantial segment of the HER2-positive metastatic breast cancer market, with sales driven by its proven efficacy and favorable safety profile relative to earlier chemotherapeutic options. However, its market penetration remains influenced by competing agents, emerging biosimilars, and evolving treatment guidelines.

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Market Dynamics Influencing EMTRIVA

Competitive Landscape

The oncology segment for HER2-positive breast cancer is highly competitive, featuring several approved therapies including:

• Pertuzumab (Perjeta): Often used in combination with trastuzumab.
• Lapatinib (Tykerb): A small-molecule tyrosine kinase inhibitor.
• Ado-trastuzumab emtansine (Kadcyla): The same molecule as EMTRIVA, but marketed under a different brand in various regions; in some cases, used synonymously, leading to shared market perception.
• Emerging Biosimilars: Although biosimilar competition is limited currently, it is anticipated to intensify market pressure over the next decade.

The introduction of new agents targeting HER2-positive cancers and combination therapies has created a dynamic environment challenging EMTRIVA’s market dominance. The ongoing development of antibody-drug conjugates like trastuzumab deruxtecan amplifies this competition.

Regulatory Landscape and Approvals

While EMTRIVA received initial approval based on compelling trial data, subsequent indications such as adjuvant therapy for early-stage disease and potential expansion into other HER2-overexpressing tumors could expand its market base. However, regulatory delays or contraindications in certain territories can impact sales.

Pricing, Reimbursement, and Market Access

Pricing strategies for EMTRIVA acknowledge both the high cost of ADCs and the necessity of coverage by payers. Managed care organizations often enforce utilization management to control expenditures, influencing prescription patterns. Price controls in key markets like Europe and Asia further shape revenue streams.

Adoption Trends

Physician familiarity, clinical guideline updates, and real-world evidence support ongoing adoption. However, the uptake may slow due to competition or emergence of superior therapies with better side effect profiles or extended indications.

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Financial Trajectory and Revenue Outlook

Historical Sales Data

Roche’s incorporated sales of EMTRIVA (or Kadcyla, in some disclosures) have grown significantly since launch, driven by expansion into early-line settings and new indications. In 2021, Roche reported €3.6 billion in sales from Kadcyla globally, up from approximately €1.6 billion in 2017, signifying sustained growth and market acceptance.

Forecasted Revenue Streams

Forecasting future revenues relies on several factors:

• Market Penetration in New Indications: Potential approval for early-stage breast cancer or HER2-positive gastric cancers could substantially increase sales.
• Patent Expiry and Biosimilar Entry: Patent protections in key markets are set to expire around 2025-2028, exposing EMTRIVA to biosimilar competition, which could lead to price erosion.
• Pipeline and Combination Regimens: Integration into combination regimens with immunotherapies or other targeted agents may improve efficacy and extend beyond current usage, offering additional growth avenues.

Revenue Risks and Opportunities

• Biosimilar Threat: Entry of biosimilars could halve or reduce market exclusivity revenues.
• Increased adoption due to clinical guidelines: Consensus updates favoring EMTRIVA in first-line or adjuvant settings could bolster sales.
• Emerging therapies: The advent of next-generation ADCs or targeted therapies might suppress EMTRIVA’s market share unless continuous innovation occurs.

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Future Outlook and Strategic Considerations

Market Expansion Potential

Expanding indications to earlier disease stages and other HER2-driven cancers presents lucrative opportunities. Regulatory milestones for these extensions will be pivotal in shaping the revenue trajectory.

Innovation and Pipeline Development

Investments in next-gen ADCs and combination strategies may preserve or expand EMTRIVA’s market share. Roche’s pipeline indicates a focus on precision oncology, including bispecifics and antibody-drug conjugates targeting novel pathways.

Pricing Strategies and Market Access

Maintaining competitive pricing coupled with value demonstration through real-world data influences future sales. Pfizer and other competitors’ biosimilars threaten to undercut pricing, demanding aggressive differentiation strategies.

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Key Takeaways

• EMTRIVA remains a cornerstone therapy for HER2-positive metastatic breast cancer with a sustained revenue base.

• Competitive pressures, such as biosimilar entry and new therapeutics, pose risks to future sales growth, especially post-2025 when patent protections lapse.

• Clinical development of new indications, including early-stage breast cancer, presents significant growth opportunities.

• Market dynamics are shaped by regulatory decisions, healthcare policies, and evolving treatment guidelines, requiring agile strategic positioning.

• Ongoing innovation and strategic collaborations will be central to maintaining EMTRIVA’s financial trajectory within an increasingly crowded landscape.

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FAQs

1. What factors could impact the future sales of EMTRIVA?
Patent expiration, biosimilar competition, regulatory approvals for new indications, and the emergence of superior or more cost-effective therapies are critical factors influencing future sales.

2. How does EMTRIVA compare to competing therapies in terms of efficacy?
Clinical trials like EMILIA have demonstrated EMTRIVA’s superior efficacy over previous standards, with notable improvements in progression-free and overall survival in second-line settings.

3. What is the potential impact of biosimilars on EMTRIVA's market share?
Biosimilar entry could lead to significant price reductions, pressuring Roche to innovate or differentiate EMTRIVA through indications, formulations, or combination therapies.

4. Are there any upcoming regulatory approvals that could influence EMTRIVA’s market?
Pending approvals for early-stage breast cancer and other HER2-overexpressing tumors may broaden EMTRIVA’s usage, positively influencing revenue streams.

5. What strategies might Roche employ to sustain EMTRIVA's market position?
Investing in pipeline development, pursuing label expansions, engaging with payers for value-based pricing, and focusing on combination strategies are key approaches.

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References

[1] Roche. Kadcyla (trastuzumab emtansine) product information.

[2] American Cancer Society. HER2-positive Breast Cancer Overview.

[3] IQVIA. Global Oncology Market Reports, 2022.

[4] EMA and FDA regulatory documents on EMTRIVA’s approvals.

[5] Roche annual reports and investor presentations, 2017–2022.