ELETRIPTAN HYDROBROMIDE - Generic Drug Details

What are the generic 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 Annora Pharma, Aurobindo Pharma, Chartwell Rx, Mylan, Regcon Holdings, Stevens J, Teva Pharms Usa, Yung Shin Pharm, Zydus Pharms, and Upjohn, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for ELETRIPTAN HYDROBROMIDE

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	2
Patent Applications:	766
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
Technophage, SA	PHASE1
VectorB2B	PHASE1
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
Teva Pharms Usa	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	202040-001	Jun 27, 2017	AB	RX	No	No
Yung Shin Pharm	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	209680-001	Jul 13, 2020		DISCN	No	No
Stevens J	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	206787-001	May 25, 2018		DISCN	No	No
Mylan	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	205152-002	Aug 11, 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	021016-002	Dec 26, 2002	5,545,644
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-001	Dec 26, 2002	6,110,940

Market Dynamics and Financial Trajectory for Eletriptan Hydrobromide

Last updated: July 27, 2025

Introduction

Eletriptan hydrobromide stands as a prominent selective serotonin receptor agonist, primarily indicated for the acute treatment of migraine headaches. Since its FDA approval in 2002, the drug has carved a significant niche in the acute migraine therapeutics segment, driven by evolving market demands and strategic commercialization efforts. This analysis explores the evolving market dynamics and financial trajectory that define the future of eletriptan hydrobromide within the competitive landscape of headache management.

Pharmacological Profile and Clinical Positioning

Eletriptan hydrobromide belongs to the triptan class of medications, renowned for their efficacy in aborting migraine attacks by targeting 5-HT1B/1D receptors. Compared to older triptans, eletriptan offers advantages such as rapid onset, high bioavailability, and improved tolerability profiles, making it a preferred choice among certain patient subsets [1].

Clinicians increasingly favor eletriptan for its favorable efficacy-to-safety ratio, especially in cases of moderate to severe migraines. The drug’s positioning against existing triptans and emerging therapies shapes its market trajectory, influencing demand and prescribing behaviors.

Market Dynamics

Demand Drivers

• Rising Migraine Prevalence: According to the World Health Organization, over a billion individuals globally suffer from migraines, with a significant proportion residing in North America and Europe. The increasing burden of migraine translates into sustained demand for effective acute treatments like eletriptan [2].

• Patient-Centric Treatment Approaches: Recent shifts towards personalized medicine emphasize rapid relief and tolerability, favoring eletriptan’s pharmacologic profile over traditional therapies. Additionally, the growing elderly population and comorbid conditions underscore the need for targeted migraine interventions.

• Availability of Generics: Patent expiration of branded eletriptan leads to the emergence of generic versions, expanding access and reducing treatment costs—a key factor bolstering market penetration, especially in price-sensitive regions.

Competitive Landscape

• Triptan Class Competition: Eletriptan contends with other triptans such as sumatriptan, rizatriptan, and zolmitriptan. Sumatriptan, as the first in the class, maintains a dominant position due to extensive clinical experience and broad market penetration. However, eletriptan's superior pharmacokinetics offers a competitive edge.

• Emerging Therapies: The advent of Gepants (e.g., ubrogepant, rimegepant) and monoclonal antibodies (e.g., erenumab) for migraine prevention and acute treatment reduce the relative share of triptans. These novel agents are positioned as alternatives for patients with contraindications or inadequate response to triptans.

• Pricing and Reimbursement Dynamics: Industry players’ strategies in pricing, reimbursement policies, and formulary placements directly influence eletriptan’s market share, especially amid healthcare cost containment initiatives.

Regulatory and Commercial Factors

• Market Expansion in Emerging Economies: Increasing urbanization, rising healthcare expenditure, and improved healthcare infrastructure open avenues for eletriptan's penetration in markets such as Asia-Pacific and Latin America.

• Patient Accessibility and Awareness: Educational initiatives and digital health tools facilitate patient and physician awareness, creating demand for effective migraine-specific therapies like eletriptan.

• Supply Chain and Manufacturing: The ability to maintain supply stability and navigate regulatory landscapes for generic manufacturing affects market competitiveness and financial stability.

Financial Trajectory

Revenue Generation and Growth Trends

Post-approval, eletriptan Hydrobromide's revenue trajectory initially experienced rapid growth in North America and Europe, driven by brand positioning and clinician awareness [3]. The subsequent patent expiry and the entry of generics led to a sharp decline in branded sales but simultaneously increased overall market volume due to lower prices.

Impact of Patent Expiry and Generics

The patent cliff in the late 2010s prompted pharmaceutical companies to diversify their portfolios or shift focus towards newer agents. Generics account for a significant proportion of eletriptan’s worldwide sales, contributing to volume growth despite reduced unit prices.

Market Penetration Strategies

• Differentiation through Formulations: Newer formulations, such as powder or dissolvable tablets, enhance patient convenience and adherence, potentially boosting sales.

• Pharmacovigilance and Safety Profile: Enhanced safety and tolerability profiles mitigate contraindications, broadening the patient eligible for eletriptan therapy, thereby positively influencing sales.

Forecasting and Investment Outlook

Analysts project a gradual recovery and stabilization of eletriptan revenues with the expansion into emerging markets and adoption of value-added formulations. However, competition from newer therapies and evolving treatment paradigms constrain long-term growth potential.

Market Trends and Future Outlook

Innovation and R&D Focus

The pharmaceutical industry’s R&D commitment towards novel migraine therapies continues to challenge the market share of existing triptans, including eletriptan. The integration of digital health and personalized medicine is anticipated to influence prescribing patterns favorably for tailored therapies.

Regulatory Environment

Regulatory landscapes evolve towards approving formulations with improved safety and convenience profiles, offering opportunities for incremental gains in eletriptan’s market share through innovative dosage forms and delivery systems.

Pricing and Access

Cost pressures and healthcare payor strategies favor generic proliferation, enhancing patient access while exerting downward pressure on revenue per unit.

Regional Market Expansion

Emerging markets will be crucial in shaping future revenues. Increasing healthcare infrastructure and rising migraine prevalence centrally position regions like Asia-Pacific as potential growth zones.

Key Takeaways

• Growing global migraine burden sustains steady demand for acute treatments like eletriptan hydrobromide, especially in developed markets.

• Patent expirations catalyzed generic competition, reducing unit costs but expanding overall market volume.

• Emerging therapies (Gepants and monoclonal antibodies) pose competitive threats, compelling manufacturers to innovate formulations and delivery systems to retain relevance.

• Market expansion in emerging economies and patient-centric formulations underpin future growth prospects.

• Pricing strategies, regulatory approvals, and technological advancements will significantly influence eletriptan's financial trajectory.

FAQs

1. How does eletriptan hydrobromide compare with other triptans in terms of efficacy?
Eletriptan generally offers comparable or superior efficacy to other triptans, with a rapid onset and favorable tolerability profile, making it a preferred choice for some clinicians for moderate to severe migraines [1].

2. What are the main factors influencing the decline in branded eletriptan sales?
Patent expiration led to increased generic entry, causing price competition and volume-driven sales growth, but reducing revenue per unit for branded formulations.

3. How do emerging migraine therapies impact eletriptan’s market potential?
New classes like Gepants and monoclonal antibodies target migraine attack and prevention differently, offering alternatives that may challenge triptan sales, especially for patients with contraindications or inadequate response.

4. What strategies are companies employing to sustain eletriptan's market relevance?
Innovating with novel formulations, expanding in emerging markets, emphasizing safety profiles, and integrating digital health tools are key strategies to sustain relevance.

5. Which regions hold the most potential for eletriptan growth in the future?
Asia-Pacific, Latin America, and parts of Africa are promising due to rising healthcare investments, increasing migraine prevalence, and expanding healthcare infrastructure.

References

[1] Goadsby, P. J., et al. "Migraine: Pathophysiology and Treatment." The Journal of Headache and Pain, vol. 20, no. 1, 2019.
[2] World Health Organization. "Migraine Fact Sheet." WHO, 2016.
[3] MarketWatch. "Eletriptan Hydrobromide Market Trends and Forecasts." 2022.