Eletriptan hydrobromide - Generic Drug Details

What are the generic drug sources for eletriptan hydrobromide and what is the scope of freedom to operate?

Eletriptan hydrobromide is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Aurobindo Pharma, Beximco Pharms Usa, Mylan, Stevens J, Teva Pharms Usa, Yung Shin Pharm, Zydus Pharms, and Upjohn, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for eletriptan hydrobromide. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for eletriptan hydrobromide

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	1
Patent Applications:	659
What excipients (inactive ingredients) are in eletriptan hydrobromide?	eletriptan hydrobromide excipients list
DailyMed Link:	eletriptan hydrobromide at DailyMed

Recent Clinical Trials for eletriptan hydrobromide

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

Sponsor	Phase
Pfizer	Phase 1
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 1

See all eletriptan hydrobromide clinical trials

Generic filers with tentative approvals for ELETRIPTAN HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
		40MG	TABLET; ORAL
		20MG	TABLET; ORAL

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 eletriptan hydrobromide

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for eletriptan hydrobromide

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for ELETRIPTAN HYDROBROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RELPAX	Tablets	eletriptan hydrobromide	20 mg and 40 mg	021016	1	2010-03-29

US Patents and Regulatory Information for eletriptan hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ajanta Pharma Ltd	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	205186-001	Aug 29, 2017	AB	RX	No	No
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002	AB	RX	Yes	Yes
Teva Pharms Usa	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	202040-001	Jun 27, 2017	AB	RX	No	No
Zydus Pharms	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	206409-002	Jun 16, 2017	AB	RX	No	No
Aurobindo Pharma	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	210708-002	Jan 15, 2019	AB	RX	No	No
Zydus Pharms	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	206409-001	Jun 16, 2017	AB	RX	No	No

Expired US Patents for eletriptan hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-001	Dec 26, 2002	5,545,644
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002	6,110,940
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-001	Dec 26, 2002	6,110,940
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002	5,545,644

Eletriptan hydrobromide Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Eletriptan Hydrobromide

Introduction to Eletriptan Hydrobromide

Eletriptan hydrobromide, a medication belonging to the triptan class, is specifically designed to treat acute migraine headaches in adults, with or without aura. Approved by the FDA in December 2002, it has been a significant player in the migraine treatment market.

Market Size and Growth Projections

The market for eletriptan hydrobromide is part of the broader migraine drugs market, which is experiencing substantial growth. As of 2023, the global migraine drugs market was estimated at USD 5.64 billion and is projected to grow at a CAGR of 11.9% from 2024 to 2030[3].

Eletriptan Market Specifics

The eletriptan market itself is anticipated to grow, albeit at a more modest rate. In 2023, the eletriptan market size was approximately $105 million and is projected to reach $109.31 million in 2024, with a forecasted growth to $147.6 million by 2032, exhibiting a CAGR of 4.1% during this period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the eletriptan market and the broader migraine drugs market:

Increasing Prevalence of Migraines

Migraines and other headache disorders affect a significant portion of the global population, with approximately 40% of the global population, or around 3.1 billion individuals, affected in 2021. This high prevalence, particularly among females, contributes to the demand for effective treatments[3].

Advancements in Drug Development

The approval of new drugs, such as CGRP antagonists like rimegepant and atogepant, and the development of new delivery methods (e.g., buccal films and nasal sprays) are enhancing treatment options and driving market growth. For instance, the Phase 3 clinical trial results of zavegepant, an investigational CGRP receptor antagonist nasal spray, have shown promising efficacy and are expected to boost market growth[3].

Consumer Demand and Unmet Needs

The high consumer base and unmet need for effective migraine treatments globally are pushing pharmaceutical companies to develop and commercialize new drugs. This includes significant investments and strategic moves such as mergers and acquisitions, like Pfizer's acquisition of Biohaven Pharmaceuticals, to strengthen market positions and expand product portfolios[3].

Pharmacokinetics and Delivery Methods

Traditional Oral Administration

Eletriptan hydrobromide is traditionally administered orally, with rapid absorption from the gastrointestinal tract and a peak plasma concentration typically occurring within 1.5 to 2 hours. However, its bioavailability is moderate, around 50%, and can be influenced by factors such as high-fat meals[2].

Innovative Delivery Methods

Recent advancements include the development of buccal films, which have shown improved pharmacokinetics compared to traditional oral solutions. These films bypass first-pass metabolism, leading to higher bioavailability and faster absorption into the bloodstream. For example, studies have shown that buccal films of eletriptan hydrobromide result in higher Cmax values and faster Tmax compared to oral solutions[5].

Competitive Landscape

The migraine drugs market is highly competitive, with various segments contributing to its growth:

Triptans

Triptans, including eletriptan, remain a cornerstone in the acute treatment of migraines. However, they face competition from newer classes of drugs like CGRP antagonists and monoclonal antibodies, which are gaining traction due to their efficacy and tolerability[3].

CGRP Antagonists and Monoclonal Antibodies

CGRP small molecule antagonists and monoclonal antibodies are emerging as significant players. These drugs have shown high efficacy in preventing migraine attacks and are preferred for their excellent tolerability and long-term safety data. The CGRP monoclonal antibodies segment dominated the market in 2023, with a market share of 57.27%[3].

Financial Implications

Revenue and Market Share

The revenue from eletriptan hydrobromide, while growing, is modest compared to the broader migraine drugs market. The market size projections indicate a steady but slower growth rate for eletriptan compared to other segments like CGRP antagonists and monoclonal antibodies[1][3].

Cost and Economic Impact

The use of eletriptan and other migraine treatments can have significant economic implications. For instance, CGRP monoclonal antibodies, although costly, offer substantial benefits in terms of more migraine-free days and improved health-related quality of life, leading to savings in both direct and indirect migraine-related costs. Each migraine-free day achieved with CGRP mAbs can result in savings ranging from approximately USD 130 to USD 340[3].

Regulatory and Clinical Context

FDA Approval and Clinical Trials

Eletriptan hydrobromide received FDA approval in December 2002 based on clinical trials that demonstrated its safety and efficacy in treating acute migraines. The drug has been evaluated in several randomized controlled trials, showing superiority over placebo and comparable or superior efficacy and tolerability to other triptans[2].

Guidelines and Recommendations

The American Headache Society (AHS) recommends the use of triptans, including eletriptan, as an A-level recommendation for the acute treatment of migraines in adults. This endorsement further supports the market position of eletriptan hydrobromide[2].

Challenges and Opportunities

Competition from Newer Drugs

The emergence of newer classes of drugs, such as CGRP antagonists and monoclonal antibodies, poses a challenge to the market share of traditional triptans like eletriptan. However, these advancements also present opportunities for innovation and collaboration within the pharmaceutical industry[3].

Innovative Delivery Systems

The development of innovative delivery systems, such as buccal films, offers opportunities to enhance the pharmacokinetics and patient compliance of eletriptan hydrobromide, potentially increasing its market appeal[5].

Key Takeaways

• The eletriptan hydrobromide market is growing, albeit at a modest rate, with a projected CAGR of 4.1% from 2024 to 2032.
• The broader migraine drugs market is driven by increasing prevalence, advancements in drug development, and high consumer demand.
• Innovative delivery methods, such as buccal films, are improving the pharmacokinetics and patient compliance of eletriptan hydrobromide.
• The market faces competition from newer classes of drugs but remains a significant player due to its established efficacy and tolerability.

FAQs

1. What is eletriptan hydrobromide used for?

Eletriptan hydrobromide is used to treat acute migraine headaches in adults, with or without aura.

2. How does eletriptan hydrobromide work?

Eletriptan hydrobromide works by targeting serotonin receptors (5-HT(1B/1D/1F)) involved in migraine pathophysiology, leading to vasoconstriction and inhibition of vascular inflammation.

3. What are the key drivers of the eletriptan market growth?

The key drivers include the increasing prevalence of migraines, advancements in drug development, and high consumer demand for effective treatments.

4. How does the bioavailability of eletriptan hydrobromide compare between oral and buccal film administration?

Buccal films of eletriptan hydrobromide show higher bioavailability and faster absorption compared to traditional oral solutions, bypassing first-pass metabolism.

5. What are the economic implications of using eletriptan hydrobromide and other migraine treatments?

While eletriptan hydrobromide and other treatments can be costly, they offer significant economic benefits in terms of reduced direct and indirect migraine-related costs and improved health-related quality of life.

Cited Sources:

1. OpenPR: Eletriptan Market Size In 2024 (New Report) Revenue to Cross
2. NCBI Bookshelf: Eletriptan - StatPearls
3. Grand View Research: Migraine Drugs Market Size, Share & Trends Report, 2030
4. BusinessWire: Global and Chinese Eletriptan Hydrobromide (CAS 143322-58-1) Industry Report 2016 - Research and Markets
5. MDPI: Statistically Optimized Polymeric Buccal Films of Eletriptan Hydrobromide and Itopride Hydrochloride: An In Vivo Pharmacokinetic Study