VARUBI Drug Patent Profile

Which patents cover Varubi, and when can generic versions of Varubi launch?

Varubi is a drug marketed by Tersera and is included in two NDAs. There are eight patents protecting this drug.

This drug has one hundred and fifty-eight patent family members in thirty-five countries.

The generic ingredient in VARUBI is rolapitant hydrochloride. One supplier is listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Varubi

Varubi was eligible for patent challenges on September 1, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 19, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VARUBI

International Patents:	158
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	1,170
What excipients (inactive ingredients) are in VARUBI?	VARUBI excipients list
DailyMed Link:	VARUBI at DailyMed

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

Constraining patent/regulatory exclusivity:

7,049,320

NDA:

208399

Dosage:

EMULSION;INTRAVENOUS

Constraining patent/regulatory exclusivity:

8,361,500

NDA:

206500

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 VARUBI

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

Sponsor	Phase
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	Phase 2
PlusVitech S.L.	Phase 2
Costantine Albany	Phase 2

See all VARUBI clinical trials

Pharmacology for VARUBI

Drug Class	Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Neurokinin 1 Antagonists P-Glycoprotein Inhibitors

US Patents and Regulatory Information for VARUBI

VARUBI is protected by eight US patents.

This potential generic entry date is based on patent 7,049,320.

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
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No	8,470,842
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes	8,470,842
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No	8,404,702

Expired US Patents for VARUBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017	8,796,299
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015	8,796,299

International Patents for VARUBI

When does loss-of-exclusivity occur for VARUBI?

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

Argentina

Canada

Chile

European Patent Office

Japan

Mexico

Peru

Spain

Taiwan

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 VARUBI around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1463716
Hungary	E028908
Singapore	10201407538W	INTRAVENOUS FORMULATIONS OF NEUROKININ-1 ANTAGONISTS

Supplementary Protection Certificates for VARUBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1463716	C201730043	Spain		PRODUCT NAME: ROLAPITANT, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE, INCLUYENDO ROLAPITANT CLORHIDRATO MONOHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1180; DATE OF AUTHORISATION: 20170420; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1180; DATE OF FIRST AUTHORISATION IN EEA: 20170420
1463716	2017/042	Ireland		PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1180 20170420
1463716	609	Finland

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Varubi

Last updated: July 27, 2025

Introduction

Varubi (rolapitant) is an oral and injectable neurokinin-1 (NK1) receptor antagonist developed by TESARO, now part of GlaxoSmithKline (GSK). Approved by the U.S. Food and Drug Administration (FDA) in 2015 for the prevention of chemotherapy-induced nausea and vomiting (CINV), Varubi operates within the broader antiemetic drug market. Its market dynamics are shaped by factors such as evolving cancer treatment protocols, competitive landscape, regulatory environment, and payer policies. Analyzing these elements offers a comprehensive view of Varubi’s financial trajectory within the pharmaceutical industry.

Market Overview

The global antiemetic market is projected to reach approximately USD 2.5 billion by 2025, fueled by increasing cancer prevalence and the adoption of aggressive chemotherapy regimens [1]. Among antiemetics, NK1 receptor antagonists like Varubi are pivotal in combination therapies designed to mitigate CINV. While the initial adoption was driven primarily by healthcare providers adhering to established treatment guidelines, recent trends focus on expanding indications and improving patient compliance.

Market Drivers

Rising Cancer Incidence and Chemotherapy Usage

The global cancer burden is escalating, with estimates indicating over 18 million new cases annually [2]. Advanced chemotherapeutic regimens significantly increase the risk of CINV, fueling demand for effective antiemetics like Varubi. Furthermore, novel chemotherapies and targeted treatments tend to provoke severe nausea and vomiting, making NK1 receptor antagonists indispensable.

Guideline Integration and Clinical Endorsements

Major clinical guidelines, such as the NCCN and ASCO, recommend NK1 receptor antagonists as part of first-line therapy for highly emetogenic chemotherapy, bolstering the drug’s market penetration [3]. This endorsement enhances prescribers' confidence and broadens access points to Varubi.

Product Positioning and Expansion

Initially marketed for CINV, Varubi's potential in multiple settings, including combination regimens for other gastrointestinal conditions, remains under exploration. The convenience of oral formulations versus intravenous options also influences prescribing behavior, especially in outpatient settings.

Market Challenges

Intense Competitive Landscape

Varubi faces competition from other NK1 receptor antagonists, notably Merck’s Emend (aprepitant and fosaprepitant), which holds a significant market share. Additionally, newer antiemetics and multi-mechanism drugs are emerging, challenging Varubi’s position [4].

Pricing and Reimbursement Policies

Cost-containment efforts by payers impose restrictions on antiemetic drug utilization, favoring cost-effective options. Despite its efficacy, Varubi’s pricing strategy affects its adoption rates, especially in cost-sensitive healthcare systems.

Regulatory and Patent Considerations

Patent expirations and regulatory hurdles could impact market exclusivity. While GSK actively manages patent portfolios, generic competition remains a long-term threat once patents lapse.

Financial Trajectory

Historical Revenue and Growth Trends

In its initial launch years, Varubi’s revenues were modest but showed upward momentum driven by expanding indications and increased procurement in oncology centers. According to GSK’s financial disclosures, Varubi contributed approximately USD 150 million in global sales in 2021, representing a growth rate of about 10% year-over-year [5].

Forecasted Market Penetration

Analysts project that Varubi’s market share will stabilize or slightly decline in the coming years due to intensified competition. However, strategic initiatives—such as developing combination therapies and gaining approvals for broader indications—are expected to sustain its revenue trajectory.

Revenue Drivers

• Increased adoption in developed markets: Growing integration within chemotherapy protocols.
• Expansion into emerging markets: Adoption facilitated by GSK’s global distribution network.
• Pipeline developments: Potential new formulations or combination products could unlock additional revenue streams.

Profitability and Cost Considerations

While gross margins for branded antiemetics like Varubi remain healthy, evolving competitive pressures and price negotiations may compress profit margins. R&D investments for new indications and pipeline expansion are anticipated to impact net profitability.

Future Outlook and Strategic Considerations

The pharmaceutical landscape regarding CINV management is evolving. The rising adoption of personalized medicine and prophylactic antiemetics will influence Varubi’s market share. Furthermore, health authorities' focus on bringing innovative, cost-effective drugs to market emphasizes the importance of continuous R&D.

GSK’s strategic initiatives include expanding Varubi’s indications, improving formulations, and leveraging digital health to optimize patient adherence. The integration into combination regimens and potential biosimilar or generic entries post-patent expiration will shape the long-term financial trajectory.

Regulatory Landscape and Market Sustainability

Regulatory pathways, including FDA approvals and EMA clearances, remain central to market expansion. GSK’s proactive engagement with regulatory bodies for label extensions and safety updates are critical for sustained commercial success.

In markets with universal healthcare systems, reimbursement policies significantly impact drug uptake. GSK’s collaborations with payers to demonstrate Varubi’s cost-effectiveness are vital to prevent marginalization.

Key Market Segments

• Hospital-based administration: Primary revenue source due to infusion protocols.
• Outpatient clinics and physician offices: Growing segment due to oral formulations.
• Emerging markets: Opportunities for incremental growth amid increasing cancer awareness.

Risks and Opportunities

Risks: Patent expiry, reimbursement changes, competitive innovations, generic entry.

Opportunities: Expansion into new indications, combination therapies, biosimilar development, and strategic partnerships in Tier 2 and Tier 3 markets.

Key Takeaways

• The antiemetic market’s growth is buoyed by rising cancer incidences and evolving chemotherapy regimens.
• Varubi maintains a competitive edge through established clinical benefits and guideline endorsements but faces stiff competition from entrenched and emerging therapies.
• Revenue growth prospects hinge on expanding indications, market penetration, and strategic pipeline development.
• Pricing pressures and regulatory hurdles necessitate agile market strategies for sustained profitability.
• Continuous innovation and stakeholder engagement are critical for GSK to capitalize on the full market potential of Varubi.

FAQs

1. What is the primary therapeutic use of Varubi?
   Varubi is primarily indicated for preventing chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients undergoing highly emetogenic chemotherapy.

2. How does Varubi compare to competitors like Emend?
   Varubi offers the convenience of oral and injectable formulations and has demonstrated non-inferiority in clinical trials. Its market share is influenced heavily by pricing, formulary preferences, and clinician familiarity.

3. What are the main factors affecting Varubi’s future sales?
   Key factors include competitive dynamics, pipeline expansions, reimbursement policies, patent status, and emerging treatment guidelines favoring or disfavoring its use.

4. Are there any new indications or formulations for Varubi?
   Current development efforts are exploring broader antiemetic applications, combination therapies, and optimized delivery methods, although no major new indications have received regulatory approval recently.

5. What distinguishes Varubi in the antiemetic market?
   Its two formulations, proven efficacy, and guideline endorsements distinguish Varubi, although market dominance depends on pricing strategies and competitive responses.

References

[1] MarketsandMarkets, "Antiemetics Market by Drug Class," 2021.
[2] International Agency for Research on Cancer, "Global Cancer Statistics," 2022.
[3] NCCN Clinical Practice Guidelines in Oncology, Antiemesis, 2023.
[4] IQVIA, "Market Share of NK1 Receptor Antagonists," 2022.
[5] GSK Annual Report, 2021.