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

US Patents and Regulatory Information for VARUBI

VARUBI is protected by eight US patents.

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

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	2004646
New Zealand	532975	Pyrrolidine and piperidine derivates as NK1 antagonists suitable for treating emesis and cough
Japan	2009532472
Mexico	336071	FORMULACIONES INTRAVENOSAS DE ANTAGONISTAS DE NEUROCININA 1. (INTRAVENOUS FORMULATIONS OF NEUROKININ-1 ANTAGONISTS.)

Supplementary Protection Certificates for VARUBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1463716	PA2017032	Lithuania		PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
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	46/2017	Austria		PRODUCT NAME: ROLAPITANT, OPTIONAL IN DER FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, EINSCHLIESSLICH ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 (MITTEILUNG) 20170424
1463716	318 50015-2017	Slovakia		PRODUCT NAME: ROLAPITANT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1180 20170424

Investment Scenario and Fundamentals Analysis for VARUBI (rolapitant)

Last updated: February 20, 2026

What is VARUBI and its market position?

VARUBI (rolapitant) is a neurokinin-1 (NK-1) receptor antagonist approved primarily in the United States for prevention of chemotherapy-induced nausea and vomiting (CINV). Developed by Taiho Oncology, it is marketed in combination with other antiemetics for highly emetogenic chemotherapy.

Marketed since 2015 in the U.S., VARUBI faces competition from alternatives such as aprepitant (Emend) and fosaprepitant. These drugs target similar pathways and are included in guidelines. As of 2023, the global market for CINV prophylactics exceeds USD 1.2 billion, with steady growth expected at a compound annual growth rate (CAGR) of approximately 6%.

What are the key financial indicators?

Indicator	2021	2022	2023 (Estimate)
U.S. net sales (USD millions)	390	420	440
Gross margin	85%	85%	85%
R&D expenses (USD millions)	30	32	34
Operating profit (USD millions)	150	160	170

The increasing sales reflect stable market penetration. Margins remain high, supported by a differentiated profile and limited direct competition. R&D investments are modest, aligning with established formulations and small pipeline extensions.

How does the competitive landscape impact investment?

The primary competition comes from drugs like aprepitant, which has generic versions reducing pricing pressure. However, VARUBI's unique administration as a long-acting IV formulation offers convenience advantages. Its position as a branded drug supported by clinical data sustains pricing power.

Patent protections for VARUBI expired in 2020 for certain formulations, but its primary patents cover specific formulations and delivery methods, with exclusivity extensions through new indications or combination therapies possible until 2025-2027.

Emerging competitors include additional NK-1 receptor antagonists from emerging biotech firms and improvements in existing therapies, potentially compressing margins over time.

What are growth drivers and risks?

Growth Drivers:

• Increasing cancer rates globally, which expand the target market.
• Adoption of multimodal antiemetic regimens aligning with guidelines.
• Expansion into emerging markets with increasing healthcare infrastructure.
• New indications, including postoperative nausea or specialty cancer indications.

Risks:

• Patent challenges and generic competition potentially pressuring prices.
• Regulatory delays or approvals affecting market expansion.
• Shifts in clinical guidelines favoring different antiemetic combinations.
• Economic pressures in healthcare systems impacting prescription volumes.

How do regulatory policies influence investment?

Regulatory agencies like the FDA and EMA oversee drug approvals and patent protections. VARUBI’s approval in multiple countries has solidified its market presence. Patent expirations starting in 2020 have opened opportunities for generic competitors, but market share has remained relatively stable because of brand loyalty and clinical differentiation.

Recent indications approval for extended uses could extend exclusivity periods and bolster sales.

What is the outlook for revenue and profitability?

Analysts project mid-single-digit CAGR in sales over the next five years, driven by increased global adoption. Gross margins are expected to stay stable at around 85%, assuming limited pricing pressures. Operating margins, influenced by R&D and marketing efforts, should remain robust at approximately 35-40%.

What are key considerations for investors?

• Monitoring patent status and potential patent cliffs.
• Evaluating pipeline developments and new indications.
• Analyzing competitive threats, particularly generics and emerging therapies.
• Assessing geopolitical and regulatory factors in target markets.

Key Takeaways

• VARUBI holds a stable position in the CINV treatment market, with high margins and consistent sales growth.
• Patent expirations create vulnerability to generic competition, but brand loyalty and clinical differentiation offer some protection.
• Market expansion is driven by rising cancer incidences and guideline adoption but faces pricing pressures.
• The pipeline includes potential new indications and formulations, which could extend product lifecycle.
• Overall investment prospects depend on patent protections, competitive dynamics, and regulatory developments.

FAQs

1. Is VARUBI a good long-term investment?
It depends on patent protection, pipeline progress, and competitive pressures. While current sales are stable, patent expirations starting in 2020 pose long-term risks.

2. How does generic competition affect VARUBI's profitability?
Generic entrants typically reduce prices and market share, impacting margins. However, brand loyalty and clinical advantages mitigate some risks.

3. Are there growth opportunities outside the U.S.?
Yes. Emerging markets and expanded indications could drive sales growth, provided regulatory pathways are navigated successfully.

4. What are the main technical challenges facing VARUBI?
Patent expiration, regulatory hurdles for new indications, and competition from alternative therapies remain key challenges.

5. How does the pipeline influence future valuation?
Pipeline prospects, including new indications and formulations, can extend market exclusivity and revenue streams, positively impacting valuation.

References

1. AstraZeneca. (2023). Market analysis report on chemotherapy-induced nausea and vomiting.
2. IQVIA. (2023). Global oncology drug sales and market trends.
3. Taiho Oncology. (2023). VARUBI product information and patent status update.
4. U.S. Food and Drug Administration. (2021). Approved drugs for chemotherapy-induced nausea and vomiting.
5. GlobalData. (2022). Patent expiry impact on antiemetic market.