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 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. Twelve 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:	12
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
Aurobindo Pharma	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	210708-002	Jan 15, 2019	AB	RX	No	No
Teva Pharms Usa	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	202040-002	Jun 27, 2017	AB	RX	No	No
Mylan	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	205152-002	Aug 11, 2017	AB	RX	No	No
Yung Shin Pharm	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	209680-001	Jul 13, 2020		DISCN	No	No
Annora Pharma	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	219143-002	Jul 7, 2025	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
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-001	Dec 26, 2002
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002

Eletriptan hydrobromide Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Eletriptan Hydrobromide?

Eletriptan hydrobromide is a selective serotonin receptor agonist used for acute migraine treatment. Its market is influenced by migraine prevalence, competitive landscape, healthcare policies, and innovation pace.

Market Size and Growth Trends

The global migraine therapeutics market, including eletriptan hydrobromide, was valued at approximately $4.3 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 3.5% from 2023 to 2030, reaching close to $6 billion by 2030 (source: MarketsAndMarkets). This growth relies on increasing migraine incidence and greater awareness.

Regional Market Distribution

North America dominates, accounting for almost 45% of revenue in 2022. The U.S. is the leading market due to high prescription rates, insurance coverage, and healthcare infrastructure. Europe follows at about 25%, with growth driven by aging populations and improved healthcare access. Asia-Pacific exhibits the fastest CAGR (~5%), driven by expanded healthcare penetration and rising migraine awareness.

Competitive Landscape

Eletriptan is marketed by Pfizer under the brand Relpax. It faces competition from other triptans such as sumatriptan, rizatriptan, and zolmitriptan. Generic versions are not yet widespread, providing patent protection until the late 2020s or early 2030s, depending on patent litigations and extensions.

Market share is affected by the drug’s efficacy, side-effect profile, ease of use, and patient preference. Eletriptan’s relatively high bioavailability and re-dosing flexibility give it an edge over some competitors. However, the presence of generics and emerging therapies (e.g., CGRP antagonists) threaten sustained growth.

Policy and Reimbursement Environment

Coverage by major health insurance plans significantly influences sales. In the U.S., Medicare and private insurers reimburse eletriptan with variable co-pays; formulary placement impacts prescribing rates. Stringent regulatory pathways in Europe and other regions demand continuous safety monitoring, affecting timelines and market access.

Innovation and Future Potentials

No major modifications or reformulations of eletriptan are publicly announced. However, research into combination therapies and improved formulations persists. The expansion of digital health tools, remote prescribing, and telemedicine enhances access, especially in underserved regions.

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What Is the Financial Trajectory of Eletriptan Hydrobromide?

The financial outlook hinges on revenue growth, patent protection, manufacturing costs, and competitive pressure.

Revenue Forecast

Pfizer generated approximately $750 million in sales from Relpax (eletriptan) in 2022. Sales declined marginally from previous years, attributable to patent exclusivity, competitive pressures, and generic entry threats.

Projected revenues over the next five years average a CAGR of about 1-2%, considered modest due to impending patent expiration and rising generic competition. By 2028, revenue may decline to around $600 million if no new formulations or indications emerge.

Patent and Exclusivity Timeline

Eletriptan’s patent protection in the U.S. extends until 2027-2028, with patent expirations in Europe following shortly after. Patent expiry often results in sharp revenue drops due to generic competition.

Cost Structure and Margins

Manufacturing costs are relatively low, given the small molecule’s synthesis process. Gross margins are high, estimated at 80-85%, driven partly by branding and limited price erosion pre-generics.

Research and development expenses for eletriptan are minimal, as the drug is off-patent in many regions. Marketing and distribution expenditures are streamlined by Pfizer’s existing migraine therapeutic portfolio infrastructure.

Market Entry of Generics and Biosimilars

The entrance of generic eletriptan products post-patent expiration is projected to cause price declines of up to 70% within two years. This will sharply reduce profit margins and overall revenue, unless Pfizer introduces new formulations or indications.

Strategic Investment Outlook

Pfizer’s focus on expanding migraine portfolio and developing personalized medicines suggests that eletriptan's future revenue may depend on integrating with broader migraine management approaches.

New formulations or combination therapies could extend lifecycle or differentiate products, but such developments are not publicly announced as of 2023.

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Summary of Market and Financial Outlook

Aspect	Status	Forecast / Impact
Market Size	Valued at $4.3B in 2022	Growth to nearly $6B by 2030
Regional Drivers	North America leads; Asia-Pacific fastest growth	Continued expansion across regions
Competition	Sumatriptan, rizatriptan, generics dominate	Price erosion post-patent expiry
Revenue (Pfizer)	~$750 million in 2022	Declining post-2027 due to generics
Patent Expiration	2027-2028 in the U.S.	Revenue decline expected post-expiry
Margins	80-85% gross margins	Compression expected with generics
R&D & Innovation	Minimal ongoing investment	Focus on formulations, new indications unlikely

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Key Takeaways

• The eletriptan hydrobromide market relies heavily on migraine prevalence, regional healthcare policies, and patent status.
• Competitive dynamics favor rapid generic entry upon patent expiration, leading to significant revenue declines.
• Pfizer’s current revenue is stable but expected to decline marginally post-2027.
• Strategic diversification and innovation may be necessary for sustained profitability beyond patent expiry.
• Emerging therapies, like CGRP antagonists, could further challenge eletriptan’s market share.

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FAQs

1. When will eletriptan hydrobromide face generic drug competition?
Patent protections in the U.S. are set to expire around 2027-2028, with European and other jurisdictions following shortly after.

2. How does eletriptan compare to other triptans?
Eletriptan has higher bioavailability and flexible dosing, which can lead to better efficacy and tolerability for some patients.

3. What factors could extend the drug’s marketability beyond patent expiry?
Developing new formulations, combination therapies, or gaining approval for additional indications could prolong lifecycle.

4. Are new migraine treatments impacting eletriptan’s market?
Yes; CGRP antagonists are preferred for some patients due to better safety profiles, potentially reducing eletriptan prescriptions.

5. What regions are most attractive for eletriptan sales growth?
North America remains dominant, but Asia-Pacific shows the fastest revenue growth, driven by expanding healthcare access.

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References

1. MarketsAndMarkets. (2022). Migraine therapeutics market report.
2. Pfizer Inc. annual reports (2022).
3. GlobalData. (2023). Pharmaceutical industry analysis.
4. FDA. (2022). Patent information for eletriptan.
5. IQVIA. (2022). Healthcare industry data.