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
PlusVitech S.L.	Phase 2
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	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
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes	8,361,500		Y
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes	8,404,702
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No	9,101,615

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
Mexico	2012001872	FORMULACIONES INTRAVENOSAS DE ANTAGONISTAS DE NEUROCININA 1. (INTRAVENOUS FORMULATIONS OF NEUROKININ-1 ANTAGONISTS.)
World Intellectual Property Organization (WIPO)	2008118331
Spain	2609640
European Patent Office	1882686	Dérives de pyrrolidine et de pipéridine en tant qu'antagonistes NK1 (Pyrrolidine and piperidine derivates as NK1 antagonists)
Peru	20120254	FORMULACIONES FARMACEUTICAS DE SALES DE 8-[1-(3,5-BIS-(TRIFLUOROMETIL)FENIL)-ETOXIMETIL]-8-FENIL-1,7-DIAZA-ESPIRO[4,5]DECAN-2-ONA
Poland	370841

Supplementary Protection Certificates for VARUBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1463716	17C1037	France		PRODUCT NAME: ROLAPITANT, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ADMISSIBLE, INCLUANT LE MONOHYDRATE DE CHLORHYDRATE DE ROLAPITANT.; REGISTRATION NO/DATE: EU/1/17/1180 20170424
2004646	C201730041	Spain		PRODUCT NAME: 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	LUC00043	Luxembourg		PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1180/001 20170424
2004646	300898	Netherlands		PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424
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	2017C/039	Belgium		PRODUCT NAME: ROLAPITANT - VARUBY; AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424

Market Dynamics and Financial Trajectory for VARUBI

Last updated: February 19, 2026

What Is the Current Market Position of VARUBI?

VARUBI (rolapitant) is an oral serotonin receptor antagonist approved by the FDA in 2015 for the prevention of chemotherapy-induced nausea and vomiting (CINV). It competes primarily with other antiemetics, such as aprepitant and palonosetron, within the anti-CINV segment.

• Market approval: U.S. (2015), EU (2016), Japan (2016).
• Indications: Prevention of delayed CINV in patients receiving highly emetogenic chemotherapy.
• Pricing: Approximately $250-$350 per dose retail, depending on formulation and insurer contracts.

In 2022, the antiemetics market was valued at around $1.3 billion, with VARUBI capturing roughly 12–15% of the segment. Growth is driven by increasing cancer treatment rates, expanding indications, and adoption in hospital and outpatient settings.

How Do Market Trends Influence VARUBI’s Revenue?

Evolving Oncology Treatments and CINV Management

Advances in cancer therapy—especially immunotherapy and targeted agents—alter CINV incidence profiles and treatment protocols.

• Increased patient exposure: Rising cancer prevalence increases demand.
• Combination therapies: Use of multiple agents enhances the need for effective antiemetics.
• Extended treatment regimens: Longer chemotherapy courses increase the requirement for prophylactic antiemetics.

Competitive Landscape

VARUBI faces competition from:

• Aprepitant (Emend): Oral and IV formulations, market leader.
• Palonosetron (Aloxi): Particularly effective for delayed CINV.
• Olanzapine: Used off-label for refractory cases.

Market share shifts depend upon efficacy, dosing convenience, side effect profiles, and insurer formulary decisions.

Regulatory and Reimbursement Factors

• FDA signals: No recent label updates, but ongoing post-marketing surveillance.
• Reimbursement policies: Coverage largely depends on hospital formularies and insurance negotiations, which influence prescribing patterns.

Geographic Expansion

European and Asian markets offer growth potential, especially in countries with rising cancer rates and expanding healthcare infrastructure.

What Is the Financial Trajectory of VARUBI?

Revenue Analysis

From 2017 to 2022, sales increased from approximately $50 million to nearly $150 million globally.

Year	Revenue (USD million)	CAGR
2017	50	—
2018	70	40%
2019	90	28.6%
2020	110	22.2%
2021	130	18.2%
2022	150	15.4%

The slowdown in growth rate post-2021 indicates market saturation potential and increasing competition pressures.

Cost Structure and Profitability

• Manufacturing costs: Estimated at 20–25% of sales.
• Pricing pressures: Negotiated discounts reduce margins.
• R&D and marketing: Compound annual expenses approach 10–15% of sales.

Pipeline and Future Opportunities

• New formulations: Development of long-acting formulations aims to address compliance.
• Expanded indications: Potential approval for pediatric populations or prophylaxis in emerging chemotherapies could expand sales.
• Partnerships: Collaborations with regional distributors could accelerate growth.

Future Revenue Projections

Assuming an annual growth rate of 10%—challenged by market saturation and biosimilar threats—sales could reach approximately $220 million by 2025.

What Risks Impede VARUBI’s Market and Financial Growth?

• Price erosion: Competitive pricing strategies by rivals.
• Generic entry: Patent expiry scheduled around 2030 may open biosimilar competition.
• Clinical challenges: Variability in patient response and evolving guidelines could limit usage.
• Regulatory delays or restrictions: Changes in label indications or reimbursement policies.

Conclusion

VARUBI’s market is characterized by modest growth driven by expanding cancer treatment volumes and need for effective antiemetic agents. Competitive dynamics and pricing pressures influence revenue and profitability. Near-term prospects depend on maintaining market share, expanding indications, and increasing geographic penetration.

Key Takeaways

• VARUBI holds a significant niche in CINV prevention, with steady revenue growth since 2017.
• Competition from established drugs like aprepitant limits market expansion.
• Revenue is unlikely to accelerate significantly beyond 2025 due to market saturation and biosimilar threats.
• Expansion into international markets offers growth unless regulatory or reimbursement barriers arise.
• Future valuation depends on securing new indications, formulations, and market expansion.

FAQs

1. When will VARUBI face generic competition?
Patent expiry is expected around 2030; biosimilar competition may emerge earlier if patents are challenged.

2. Are there approvals for VARUBI outside oncology?
No, current approvals focus solely on CINV related to cancer chemotherapy.

3. What are the main competitors to VARUBI?
Aprepitant (Emend), palonosetron (Aloxi), and off-label agents like olanzapine.

4. Can future pipeline developments influence VARUBI’s market?
Yes, long-acting formulations and expanded indications could drive future sales.

5. How does reimbursement impact VARUBI’s revenue?
Coverage variations across hospitals and insurance plans influence prescribing and sales volume.

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References

[1] MarketsandMarkets. (2022). Anti-emetics market size and forecast. Retrieved from https://www.marketsandmarkets.com/

[2] U.S. Food and Drug Administration (FDA). (2015). VARUBI approval notice.

[3] IQVIA. (2022). Oncology therapeutics market report.

[4] Evaluate Pharma. (2022). Pharmaceutical sales data.