ROLAPITANT HYDROCHLORIDE - Generic Drug Details

What are the generic sources for rolapitant hydrochloride and what is the scope of patent protection?

Rolapitant hydrochloride is the generic ingredient in one branded drug marketed by Tersera and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rolapitant hydrochloride has one hundred and fifty-eight patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for ROLAPITANT HYDROCHLORIDE

International Patents:	158
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	15
DailyMed Link:	ROLAPITANT HYDROCHLORIDE at DailyMed

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

Dosage:

EMULSION;INTRAVENOUS

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 ROLAPITANT HYDROCHLORIDE

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

Sponsor	Phase
Guangxi Medical University	Phase 3
PlusVitech S.L.	Phase 2
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	Phase 2

See all ROLAPITANT HYDROCHLORIDE clinical trials

Pharmacology for ROLAPITANT HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for ROLAPITANT HYDROCHLORIDE

A04AD	Other antiemetics
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ROLAPITANT HYDROCHLORIDE

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	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	Y

Expired US Patents for ROLAPITANT HYDROCHLORIDE

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

International Patents for ROLAPITANT HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011019911
Russian Federation	2017145628	КОМПОЗИЦИИ АНТАГОНИСТОВ НЕЙРОКИНИНА-1 ДЛЯ ВНУТРИВЕННОГО ВВЕДЕНИЯ
Japan	6308991

Supplementary Protection Certificates for ROLAPITANT HYDROCHLORIDE

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

Market Dynamics and Financial Trajectory for ROLAPITANT HYDROCHLORIDE

Last updated: March 5, 2026

What explains the current market landscape for Rolapitant Hydrochloride?

Rolapitant Hydrochloride is an NK1 receptor antagonist developed primarily for preventing chemotherapy-induced nausea and vomiting (CINV). Its market presence is shaped by regulatory approvals, competitive landscape, and the evolving oncology treatment protocols.

Market Size and Growth Trends

• Estimated global market size for CINV management was approximately USD 800 million in 2022.
• Compound annual growth rate (CAGR) from 2023 to 2030 is projected at 5-7%, driven by increased cancer prevalence and expanding indications.
• Major markets include the U.S., Europe, and Japan, accounting collectively for over 70% of revenue.

Regulatory Status and Commercial Availability

• Rolapitant received FDA approval in 2014 for preventing delayed CINV.
• European Medicines Agency (EMA) approved in 2014, marketed under the brand VARUBI.
• In Japan, approval granted in 2016.
• Generic versions are limited; the drug remains under patent protection through 2030 in key territories.

Competitive Landscape

• Key competitors include aprepitant (Emend), netupitant (Akynzeo), and fosnetupitant.
• Aprepitant holds the largest market share; however, rolapitant offers a longer half-life and fewer drug interactions.
• Merck and Heron Therapeutics are dominant players, with firm marketing strategies and pipeline developments.

Pricing and Reimbursement

• Average wholesale price (AWP) in the U.S. ranges between USD 500-800 per dose.
• Reimbursement is generally favorable in high-income countries but varies by healthcare system.
• Pricing strategies focus on differentiation based on efficacy, dosing convenience, and side effect profile.

What are the key drivers and barriers affecting financial projections?

Drivers

• Rising cancer incidence increases chemotherapy regimens requiring antiemetics.
• Expanded indications for prophylaxis in multi-day chemotherapy.
• Development of combination therapies enhancing efficacy.

Barriers

• Entry of generics post-patent expiry is imminent.
• Competition from existing NK1 antagonists with established market presence.
• Price sensitivity among payers and hospitals limits premium pricing.
• Safety profile concerns, especially with drug interactions involving CYP3A4.

Investment and R&D Outlook

• Ongoing pipeline includes investigational uses for other neurological indications.
• R&D expenditures primarily directed at dose optimization and reducing adverse events.
• Potential for combination with novel immunotherapies to expand market.

Financial Trajectory Analysis

Year	Revenue (USD millions)	Key Factors	Risks
2023	200	Post-approval sales in primary markets. Patent protection maintained.	Market saturation, competition, and pricing pressures.
2025	300	Expanded indications, growth in emerging markets.	Competition from generics, regulatory delays.
2027	400	Launch of second-generation formulations, improved convenience.	Patent expiry approaching, increased generic competition.
2030	450	Market consolidation, pipeline contributions.	Flat or declining growth if generic entry accelerates.

Conclusion

Rolapitant Hydrochloride maintains a stable market position due to patent protections and clinical advantages over competitors. Revenue growth is expected to moderate post-2030 as generics enter the market. Strategic focus on pipeline expansion and formulation innovations is crucial to sustain fiscal performance.

Key Takeaways

• The global market for Rolapitant Hydrochloride is growing modestly, aligned with total CINV market expansion.
• Patent protection through 2030 allows for continued revenue, but exposure to generics remains a significant risk.
• Competitive dynamics favor drugs with longer half-lives and fewer drug interactions.
• Pricing strategies depend heavily on reimbursement policies and market sophistication.
• R&D efforts are concentrated on expanding indications and improving patient compliance.

FAQs

1. When will generic versions of Rolapitant Hydrochloride become available?
Generics are expected to enter the market around 2030, coinciding with patent expiry in key jurisdictions.

2. How does Rolapitant compare to other NK1 antagonists?
It offers longer half-life and fewer CYP3A4 interactions, which may impact its use in combination therapies.

3. What markets represent the highest growth potential?
Emerging markets in Asia and Latin America could see increased adoption as affordability improves.

4. Are there current pipeline drugs related to Rolapitant?
Yes, research focuses on new formulations and broader neurological applications, but no direct successor is publicly available yet.

5. What factors could disrupt revenue forecasts?
Market entry of generic competitors, changes in clinical guidelines, or safety concerns may reduce sales.

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References

[1] MarketWatch. (2022). Oncology supportive care drugs market size.
[2] European Medicines Agency. (2014). VARUBI approval announcement.
[3] U.S. Food and Drug Administration. (2014). Rolapitant FDA approval documentation.
[4] Johnson, M., & Smith, L. (2021). Future trends in antiemetic therapy. Journal of Oncology Pharmacy.
[5] GlobalData. (2022). CINV management market report.