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
Patent Applications:	729
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
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	Phase 2
PlusVitech S.L.	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	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
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No			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
Russian Federation	2642234	КОМПОЗИЦИИ АНТАГОНИСТОВ НЕЙРОКИНИНА-1 ДЛЯ ВНУТРИВЕННОГО ВВЕДЕНИЯ (ANTAGONISTS NEUROKININ-1 COMPOSITIONS FOR INTRAVENOUS INTRODUCTION)
Peru	20142329	SALES DE HIDROCLORURO DE 8-[{1-(3,5-BIS-(TRIFLUOROMETIL)FENIL)-ETOXI}-METIL]-8-FENIL-1,7-DIAZASPIRO[4.5]DECAN-2-ONA
Taiwan	I498329

Supplementary Protection Certificates for ROLAPITANT HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	CR 2017 00041	Denmark		PRODUCT NAME: ROLAPITANT, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, INKLUSIV ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REG. NO/DATE: EU/1/17/1180 20170424

ROLAPITANT HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rolapitant Hydrochloride

Introduction

Rolapitant hydrochloride, marketed under the brand name VARUBI, is a significant player in the pharmaceutical market, particularly in the treatment of chemotherapy-induced nausea and vomiting (CINV). Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Regulatory Landscape

Rolapitant hydrochloride was approved by the FDA on September 1, 2015, for oral use and later on October 25, 2017, for intravenous use[2][4].

• The drug has a robust patent portfolio with 158 patent family members in 35 countries, ensuring a strong market position[1].

Clinical Significance and Efficacy

Rolapitant has demonstrated promising results in clinical trials, particularly in reducing CINV in patients undergoing chemotherapy.

• It has shown efficacy in both the acute and delayed phases of CINV, making it a valuable option for patients undergoing chemotherapy[4].

Market Competition

The market for CINV treatments is competitive, with other notable drugs like Merck & Co.’s Emend.

• However, analysts have highlighted rolapitant as a potential "best in class" medication due to its efficacy and long-lasting action[3].

Sales Projections and Financial Performance

Analysts have been optimistic about the financial potential of rolapitant.

• Citigroup analyst Yaron Weber predicted that the oral version of rolapitant could generate $425 million in sales by 2027, comparing it favorably to Emend, which had sales of $419 million in 2011[3].

Pharmaceutical Company Performance

Tesaro, the developer of rolapitant, went public in June 2012 and has since been focused on bringing this drug to market.

• The company's financial trajectory has been influenced significantly by the approval and sales performance of rolapitant, which has been a key driver of its revenue[3].

Pricing and Cost Considerations

The pricing of VARUBI is critical to its market success.

• While specific pricing details are not publicly available without a subscription, the drug's value proposition lies in its efficacy and the reduction of healthcare costs associated with managing CINV[1].

Patient and Market Adoption

The adoption of rolapitant has been driven by its clinical benefits and the need for effective CINV treatments.

• Studies have shown that rolapitant is well-tolerated and effective, leading to increased adoption by healthcare providers and patients[2][4].

Pharmacokinetics and Metabolism

Rolapitant's pharmacokinetic profile is favorable, with a high bioavailability and a long elimination half-life of approximately 7 days.

• This profile supports its efficacy and convenience, as it does not require frequent dosing, which can enhance patient compliance and market acceptance[4].

Side Effects and Safety Profile

The safety profile of rolapitant has been evaluated extensively in clinical trials.

• While it has shown some adverse effects, particularly at higher doses, the overall safety profile is acceptable, and the drug has been approved for use in various patient populations[2][4].

Impact on Healthcare Costs

By effectively managing CINV, rolapitant can reduce healthcare costs associated with hospitalizations and additional treatments for nausea and vomiting.

• This cost-effectiveness is a significant factor in its market dynamics, making it an attractive option for both patients and healthcare systems[3].

Global Reach and Distribution

Rolapitant is approved and marketed in several countries, with a broad distribution network.

• The drug is registered under various product names and has been authorized in the EU and other regions, expanding its global reach[1].

Future Outlook

The future outlook for rolapitant is positive, driven by its clinical efficacy and market demand.

• As more patients undergo chemotherapy and require effective CINV treatments, the demand for rolapitant is expected to grow, contributing to its financial trajectory[3].

Key Takeaways

• Approval and Regulatory Landscape: Approved by the FDA in 2015 and 2017 for oral and intravenous use, respectively.
• Clinical Significance: Effective in reducing CINV in both acute and delayed phases.
• Market Competition: Positioned as a "best in class" medication against competitors like Emend.
• Sales Projections: Predicted to generate $425 million in sales by 2027.
• Pharmaceutical Company Performance: Significant revenue driver for Tesaro.
• Pricing and Cost Considerations: Value proposition lies in efficacy and cost reduction.
• Patient and Market Adoption: Driven by clinical benefits and need for effective CINV treatments.
• Pharmacokinetics and Metabolism: Favorable profile with high bioavailability and long half-life.
• Side Effects and Safety Profile: Acceptable safety profile with some adverse effects at higher doses.
• Impact on Healthcare Costs: Reduces costs associated with managing CINV.
• Global Reach and Distribution: Approved and marketed in several countries.
• Future Outlook: Positive, driven by clinical efficacy and market demand.

FAQs

What is the primary use of rolapitant hydrochloride?

Rolapitant hydrochloride is primarily used to treat chemotherapy-induced nausea and vomiting (CINV).

When was rolapitant hydrochloride approved by the FDA?

Rolapitant hydrochloride was approved by the FDA on September 1, 2015, for oral use and on October 25, 2017, for intravenous use.

How does rolapitant compare to other CINV treatments?

Rolapitant is considered a "best in class" medication due to its efficacy and long-lasting action, comparing favorably to other treatments like Merck & Co.’s Emend.

What are the predicted sales for rolapitant hydrochloride?

Analysts predict that rolapitant could generate $425 million in sales by 2027.

What is the pharmacokinetic profile of rolapitant hydrochloride?

Rolapitant hydrochloride has a high bioavailability and a long elimination half-life of approximately 7 days, supporting its efficacy and convenience.

Sources

1. DrugPatentWatch: VARUBI Drug Patent Profile.
2. FDA: VARUBI™ (rolapitant) tablets, for oral use.
3. Drug Discovery Trends: Big Things Expected from Rolapitant.
4. FDA: 206500Orig1s000 - Summary Review.