Aprepitant - Generic Drug Details

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

Aprepitant is the generic ingredient in four branded drugs marketed by Glenmark Speclt, Sandoz, Torrent, Merck, Heron Theraps Inc, and Msd Merck Co, and is included in seven NDAs. There are twelve patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aprepitant has fifty-seven patent family members in thirty-seven countries.

There are twenty-six drug master file entries for aprepitant. Five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for aprepitant

International Patents:	57
US Patents:	12
Tradenames:	4
Applicants:	6
NDAs:	7
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	175
Patent Applications:	4,952
Drug Prices:	Drug price trends for aprepitant
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aprepitant
What excipients (inactive ingredients) are in aprepitant?	aprepitant excipients list
DailyMed Link:	aprepitant at DailyMed

See drug prices for aprepitant

Recent Clinical Trials for aprepitant

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

Sponsor	Phase
Hubei Cancer Hospital	N/A
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Guangxi Medical University	Phase 3

See all aprepitant clinical trials

Generic filers with tentative approvals for APREPITANT

Applicant	Application No.	Strength	Dosage Form
		130MG/130ML	INJECTION, EMULSION
		130MG/18ML (7.2MG/ML)	INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for aprepitant

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

Anatomical Therapeutic Chemical (ATC) Classes for aprepitant

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

Paragraph IV (Patent) Challenges for APREPITANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APONVIE	Intravenous Emulsion	aprepitant	32 mg/4.4 mL	216457	1	2023-11-07
CINVANTI	Intravenous Emulsion	aprepitant	130 mg/18 mL	209296	1	2022-04-29
EMEND	for Oral Suspension	aprepitant	125 mg/Kit	207865	1	2016-11-23
EMEND	Capsule	aprepitant	40 mg, 80 mg and 125 mg	021549	1	2008-11-03

US Patents and Regulatory Information for aprepitant

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	021549-002	Mar 26, 2003	AB	RX	Yes	Yes	8,258,132		Y
Sandoz	APREPITANT	aprepitant	CAPSULE;ORAL	090999-001	Sep 24, 2012	AB	RX	No	No
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes	11,744,800		Y
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes	11,173,118		Y
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes	9,974,794		Y
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes	10,624,850
Sandoz	APREPITANT	aprepitant	CAPSULE;ORAL	090999-002	Sep 24, 2012	AB	RX	No	No

Expired US Patents for aprepitant

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003	5,719,147
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003	6,096,742
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006	6,096,742
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003	6,235,735
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006	5,145,684
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003	5,719,147
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003	6,096,742

EU/EMA Drug Approvals for aprepitant

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 aprepitant

Country	Patent Number	Title	Estimated Expiration
Poland	211243
Mexico	PA04005563	COMPOSICION FARMACEUTICA DE UN ANTAGONISTA DE RECEPTORES DE TAQUICININA. (PHARMACEUTICAL NANOPARTICULATE COMPOSITION OF A TACHYKININ RECEPTOR ANTAGONIST.)
New Zealand	534009	Pharmaceutical nanoparticulate composition of a tachykinin receptor antagonist
Ecuador	SP045144	COMPOSICIÓN FARMACÉUTICA DE UN ANTAGONISTA DE RECEPTORES DE TAQUICININA
Serbia	50404
Iceland	7276
Hong Kong	1078017

Supplementary Protection Certificates for aprepitant

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0734381	3/2004	Austria		PRODUCT NAME: APREPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/03/262/001 - EU/1/03/262/006 20031111
0748320	08C0019	France		PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
0734381	PA2004002	Lithuania		PRODCUT 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/1/03/262/001-006/20031111
0734381	04C0010	France		PRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
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
0748320	SPC/GB08/021	United Kingdom		PRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111
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

Aprepitant Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aprepitant

Market Overview

Aprepitant, a drug widely recognized for its efficacy in managing chemotherapy-induced nausea and vomiting (CINV), is a pivotal component of modern cancer care. The market for aprepitant is characterized by several key dynamics that influence its growth and financial trajectory.

Key Drivers of the Aprepitant Market

Growing Prevalence of Cancer

The increasing incidence of cancer globally is a significant driver for the aprepitant market. As cancer therapies become more advanced and common, the need for effective antiemetic drugs like aprepitant rises[4].

Expanding Applications

Aprepitant's use is not limited to CINV; it is also effective in treating postoperative nausea and other forms of acute nausea. This broadening of indications contributes to the market's growth[4].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in regions like North America, Europe, and the Asia-Pacific, enhance the accessibility and affordability of aprepitant, driving market expansion[1].

Increasing Awareness and Adoption

Growing awareness among patients and healthcare professionals about the benefits of aprepitant in preventing nausea and vomiting associated with chemotherapy and surgery is another key driver. This increased awareness leads to higher adoption rates[4].

Market Segmentation

By Product Type

The aprepitant market is segmented into various product types, including capsules, injectable solutions, tablets, and oral suspensions. Each form has its own market share and growth trajectory, influenced by patient preferences and clinical needs[4].

By Application

The market is also segmented by application, with the primary segments being chemotherapy-induced nausea, postoperative nausea, and acute nausea. The chemotherapy-induced nausea segment dominates the market due to the high prevalence of cancer[4].

By Region

Geographically, the market is led by North America, followed closely by Europe. The Asia-Pacific region is experiencing rapid growth due to rising awareness and improving healthcare access. Emerging regions like Latin America and the Middle East also show promising potential[1].

Financial Trajectory

Market Size and Growth

The global aprepitant market size was valued at USD 1.2 billion in 2023 and is projected to reach USD 1.9 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.5% from 2024 to 2031[4].

Revenue Projections

The market's financial growth is supported by the increasing demand for aprepitant in various therapeutic areas. For instance, the global CINV existing and pipeline drugs market, which includes aprepitant, is expected to grow from USD 1.9 billion in 2021 to USD 3.2 billion by 2031, at a CAGR of 5.8%[3].

Key Players and Competitive Landscape

Major Market Players

The aprepitant market is competitive, with key players such as Merck & Co., Heron Therapeutics, Sandoz, and Glenmark Pharmaceuticals driving innovation and growth. These companies are involved in research and development to enhance aprepitant formulations and explore new therapeutic areas[1].

Strategic Collaborations and Expansions

Industry players are forging strategic collaborations and expanding their product portfolios to meet the rising demand for aprepitant. For example, Heron Therapeutics has seen positive momentum in its oncology care franchise, which includes aprepitant, and has received FDA approvals for expanded indications[2].

Impact of Technological Innovations

AI-Driven Drug Discovery

The adoption of new technologies such as AI-driven drug discovery and precision medicine is reshaping the aprepitant market. These innovations facilitate the development of more effective antiemetic drugs, enhancing patient outcomes[1].

Precision Medicine

Precision medicine approaches are also contributing to the market's growth by allowing for more targeted and effective treatments, which can include personalized antiemetic regimens using aprepitant[1].

Regional Market Analysis

North America

North America dominates the aprepitant market due to its robust healthcare infrastructure and the high prevalence of cancer cases. The region is expected to continue leading the market during the forecast period[1].

Europe

Europe follows closely behind North America, with significant research initiatives and a growing aging population driving the demand for aprepitant[1].

Asia-Pacific

The Asia-Pacific region is experiencing rapid market expansion fueled by rising awareness about CINV and improving healthcare access. Countries like Japan, China, and India are key contributors to this growth[1].

Latin America and Middle East

Emerging regions such as Latin America and the Middle East show promising potential, with pharmaceutical companies actively venturing into these markets to tap into their burgeoning patient populations[1].

Financial Performance of Key Players

Heron Therapeutics

Heron Therapeutics, a key player in the aprepitant market, reported increased sales trajectory in both its acute care and oncology care franchises in the fourth quarter of 2023. The company reaffirmed its financial guidance for 2024, indicating a positive financial outlook[2].

Market Attractiveness Analysis

By Major Drugs

The market attractiveness analysis by major drugs, including aprepitant, shows that these drugs are highly attractive due to their efficacy and the growing demand for antiemetic treatments[3].

By Region

The market attractiveness analysis by region highlights the potential of emerging markets like the Asia-Pacific and Latin America, which are expected to contribute significantly to the market's growth in the coming years[3].

Challenges and Restraints

Pricing and Reimbursement

Pricing strategies and reimbursement support are crucial factors influencing the affordability and accessibility of aprepitant therapy. Financial services, including insurance coverage, play a significant role in making the drug accessible to patients[1].

Regulatory Approvals

The need for regulatory approvals and the complexity of the approval process can act as restraints to market growth. However, recent approvals, such as the FDA approval for Heron Therapeutics' supplemental New Drug Application (sNDA), indicate a positive regulatory environment[2].

Conclusion

The aprepitant market is poised for significant growth driven by the increasing prevalence of cancer, expanding applications, and advancements in healthcare infrastructure. Key players are driving innovation, and technological advancements are enhancing patient outcomes. However, challenges such as pricing and regulatory approvals need to be navigated to fully realize the market's potential.

Key Takeaways

• The global aprepitant market is expected to grow from USD 1.2 billion in 2023 to USD 1.9 billion by 2031.
• North America dominates the market, followed by Europe and the Asia-Pacific region.
• Key drivers include the growing prevalence of cancer, expanding applications, and advancements in healthcare infrastructure.
• Technological innovations such as AI-driven drug discovery and precision medicine are enhancing market growth.
• Pricing and reimbursement strategies are critical for market accessibility.

FAQs

What is the primary use of aprepitant?

Aprepitant is primarily used to manage chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea.

Who are the key players in the aprepitant market?

Key players include Merck & Co., Heron Therapeutics, Sandoz, and Glenmark Pharmaceuticals.

What is the expected growth rate of the aprepitant market?

The aprepitant market is expected to grow at a CAGR of 5.5% from 2024 to 2031.

Which region dominates the aprepitant market?

North America dominates the aprepitant market due to its robust healthcare infrastructure and high prevalence of cancer cases.

What are the major challenges facing the aprepitant market?

Major challenges include pricing strategies, reimbursement support, and regulatory approvals.

Sources

1. Aprepitant Market Analysis and Global Regional Outlook - OpenPR
2. Heron Therapeutics Announces Fourth Quarter and Full-Year 2023 - Heron Therapeutics
3. CINV Existing and Pipeline Drugs Market Analysis Report 2031 - Transparency Market Research
4. Aprepitant Market Size and Projections - Market Research Intellect