EMEND Drug Patent Profile

When do Emend patents expire, and when can generic versions of Emend launch?

Emend is a drug marketed by Merck, Msd Merck Co, and Merck And Co Inc. and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has forty-eight patent family members in thirty-seven countries.

The generic ingredient in EMEND is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emend

A generic version of EMEND was approved as fosaprepitant dimeglumine by FRESENIUS KABI USA on June 9^th, 2016.

Summary for EMEND

International Patents:	48
US Patents:	1
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Patent Applications:	2,252
Drug Prices:	Drug price information for EMEND
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMEND
What excipients (inactive ingredients) are in EMEND?	EMEND excipients list
DailyMed Link:	EMEND at DailyMed

See drug prices for EMEND

Pharmacology for EMEND

Drug Class	Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

Paragraph IV (Patent) Challenges for EMEND

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMEND	for Oral Suspension	aprepitant	125 mg/Kit	207865	1	2016-11-23
EMEND	Injection	fosaprepitant dimeglumine	150 mg/vial	022023	2	2012-01-25
EMEND	Capsule	aprepitant	40 mg, 80 mg and 125 mg	021549	1	2008-11-03

US Patents and Regulatory Information for EMEND

EMEND is protected by three US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006		DISCN	Yes	No			Y
Msd Merck Co	EMEND	aprepitant	FOR SUSPENSION;ORAL	207865-001	Dec 17, 2015		RX	Yes	Yes			Y
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008		DISCN	Yes	No
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003	AB	RX	Yes	No			Y

Expired US Patents for EMEND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010

EU/EMA Drug Approvals for EMEND

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Emend	aprepitant	EMEA/H/C/000527 Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics).Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.	Authorised	no	no	no	2003-11-11

International Patents for EMEND

See the table below for patents covering EMEND around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9523798
Taiwan	385308
Yugoslavia	14495
Germany	122008000037

Supplementary Protection Certificates for EMEND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0734381	SPC/GB04/011	United Kingdom		PRODUCT NAME: APREPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/03/262/001 20031113; UK EU/1/03/262/002 20031113; UK EU/1/03/262/003 20031113; UK EU/1/03/262/004 20031113; UK EU/1/03/262/005 20031113; UK EU/1/03/262/006 20031113
0734381	CA 2004 00009	Denmark
0734381	91069	Luxembourg		91069, EXPIRES: 20181111
0734381	PA2004002,C0734381	Lithuania		PRODUCT NAME: 5-(((2R,3S)-2-((1R)-1-(3,5-BIS(TRIFLUORMETIL)FENIL)ETOKSI)-3-(4-FLUORFENIL)-4-MORFOLINIL)METIL)-1,2-DIHIDRO-3H-1,2,4-TRIAZOL-3-ONAS (APREPITANTAS); REGISTRATION NO/DATE: EU/1/03/262/001, 2003 11 11, EU/1/03/262/002, 2003 11 11, EU/1/03/262/003, 2003 11 11, EU/1/03/262/004, 2003 11 11, EU/1/03/262/005, 2003 11 11, EU/1/03/262/006 20031111

EMEND Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EMEND (Aprepitant)

Introduction to EMEND (Aprepitant)

EMEND, also known as aprepitant, is a potent antiemetic drug used primarily to prevent chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea. Developed by Merck & Co., Inc., EMEND has become a cornerstone in the management of emesis associated with cancer therapies.

Market Size and Growth

The global market for CINV existing and pipeline drugs, which includes EMEND, was valued at USD 1.62 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.9% from 2024 to 2030, reaching approximately USD 2.27 billion by 2030[1][3].

Specifically, the aprepitant market, which is a significant segment within the CINV market, was valued at USD 1.2 billion in 2023 and is expected to reach USD 1.9 billion by 2031, growing at a CAGR of 5.5% from 2024 to 2031[4].

Key Drivers of Market Growth

Several factors are driving the growth of the EMEND market:

Advancements in Targeted Therapies

Advancements in cancer treatments and the increasing use of targeted therapies have led to a higher incidence of CINV, thereby increasing the demand for effective antiemetic drugs like EMEND[3][4].

Growing Focus on Patient-Centric Solutions

There is a growing emphasis on patient-centric solutions, which includes better management of side effects such as nausea and vomiting. This focus has increased the adoption of EMEND in clinical settings[3].

Expanding Indications

The approval of EMEND for a wider range of uses, including both highly and moderately emetogenic chemotherapy, as well as postoperative nausea, has expanded its market reach[5].

Financial Performance of EMEND

Sales Figures

Heron Therapeutics, which markets CINVANTI, an injectable emulsion form of aprepitant, reported significant sales growth. For the year 2023, CINVANTI achieved net product sales of $94.9 million, up from $87.3 million in 2022[2].

Revenue Projections

Given the growing demand for antiemetic drugs, the revenue from EMEND and its formulations is expected to continue on an upward trajectory. The overall CINV market, which includes EMEND, is projected to reach USD 2.29 billion by 2032 at a CAGR of 3.2%[3].

Market Segmentation

The CINV market, including EMEND, is segmented based on drug types and end-use applications:

Drug Types

• Aloxi (palonosetron)
• Zofran Generic (ondansetron)
• Kytril Generic (granisetron)
• Emend (aprepitant)
• Akynzeo (netupitant-palonosetron)
• SUSTOL (extended release granisetron injection)
• Rolapitant[1][3]

End-Use Applications

• Hospitals
• Specialty Clinics
• Hospital Pharmacies
• Drugstores[1][3]

Competitive Landscape

The CINV market is highly competitive with several key players, including Merck & Co., Inc., Heron Therapeutics, and others. Heron Therapeutics, for instance, has seen significant growth in its oncology care franchise, which includes CINVANTI, a formulation of aprepitant[2].

Clinical Efficacy and Safety

EMEND has been clinically proven to prevent acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy. When used in combination with ondansetron and dexamethasone, EMEND has shown high efficacy in clinical trials[5].

Pharmacokinetics and Dosage

The pharmacokinetics of EMEND are well-studied, showing no significant differences in plasma clearance between genders or in patients with renal insufficiency. This makes EMEND a versatile option for a wide range of patients without the need for dosage adjustments based on gender or renal function[5].

Future Outlook

The future outlook for EMEND is promising due to several factors:

Increasing Cancer Incidence

The rising incidence of cancer and the need for efficient antiemetic treatments will continue to drive the demand for EMEND[4].

Expanding Healthcare Infrastructure

Improvements in healthcare infrastructure and access to cancer treatments will further support the growth of the EMEND market[4].

Growing Awareness

Growing awareness among patients and healthcare professionals about the benefits of effective antiemetic drugs will also contribute to the market's expansion[4].

Key Takeaways

• Market Growth: The CINV market, including EMEND, is expected to grow significantly, driven by advancements in cancer therapies and a growing focus on patient-centric solutions.
• Financial Performance: EMEND and its formulations have shown strong sales growth and are projected to continue this trend.
• Clinical Efficacy: EMEND has been clinically proven to be highly effective in preventing CINV.
• Market Segmentation: The market is segmented by drug types and end-use applications, with hospitals and specialty clinics being key segments.
• Future Outlook: The market is expected to expand due to increasing cancer incidence, improving healthcare infrastructure, and growing awareness of antiemetic benefits.

FAQs

Q: What is the expected market size of the CINV existing and pipeline drugs market by 2030? A: The CINV existing and pipeline drugs market is expected to reach approximately USD 2.27 billion by 2030[1].

Q: What is the CAGR of the aprepitant market from 2024 to 2031? A: The aprepitant market is expected to grow at a CAGR of 5.5% from 2024 to 2031[4].

Q: What are the key drivers of the EMEND market? A: Key drivers include advancements in targeted therapies, a growing focus on patient-centric solutions, and expanding indications for use[3][4].

Q: How does EMEND perform in clinical settings? A: EMEND has been clinically proven to prevent acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy[5].

Q: Does EMEND require dosage adjustments based on gender or renal function? A: No, EMEND does not require dosage adjustments based on gender or renal function[5].

Sources

1. Maximize Market Research: Global CINV Existing and Pipeline Drugs Market Report[1].
2. Heron Therapeutics: Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Updates[2].
3. Business Research Insights: CINV Existing and Pipeline Drugs Market Size, Forecast | 2032[3].
4. Market Research Intellect: Aprepitant Market Size and Projections[4].
5. FDA: Supplemental New Drug Application for Emend (aprepitant)[5].