RELPAX Drug Patent Profile

Which patents cover Relpax, and what generic alternatives are available?

Relpax is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in RELPAX is eletriptan hydrobromide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the eletriptan hydrobromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Relpax

A generic version of RELPAX was approved as eletriptan hydrobromide by ZYDUS PHARMS on June 16^th, 2017.

Summary for RELPAX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	3,327
Drug Prices:	Drug price information for RELPAX
What excipients (inactive ingredients) are in RELPAX?	RELPAX excipients list
DailyMed Link:	RELPAX at DailyMed

See drug prices for RELPAX

See drug sales revenues for RELPAX

Recent Clinical Trials for RELPAX

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

Sponsor	Phase
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 1
Pfizer	Phase 1
GlaxoSmithKline	Phase 3

See all RELPAX clinical trials

Pharmacology for RELPAX

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

Paragraph IV (Patent) Challenges for RELPAX

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 RELPAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-001	Dec 26, 2002	AB	RX	Yes	No
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002	AB	RX	Yes	Yes

Expired US Patents for RELPAX

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	021016-002	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

International Patents for RELPAX

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

Country	Patent Number	Title	Estimated Expiration
Poland	180867
Turkey	9501061
Canada	2178161	DERIVES DE L'INDOLE (INDOLE DERIVATIVES)
New Zealand	263614	PHARMACEUTICAL USE OF 5-(METHYLAMINOSULPHONYLMETHYL)-3- (N-METHYLPYRROLIDIN-2-YLMETHYL)-1H-INDOLE AND OF THE CORRESPONDING -3-(PYRROLIDIN-2-YLMETHYL)-DERIVATIVE
Peru	41596	SAL DE UN DERIVADO DE INDOL CONTRA LA MIGRANA
Brazil	9503812

Supplementary Protection Certificates for RELPAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0592438	36/2001	Austria		PRODUCT NAME: ELETRIPTAN UND DIE PHARMAZEUTISCH VERTRAEGLICHEN SALZE DAVON, EINSCHLIESSLICH DES HYDROBROMIDS; NAT. REGISTRATION NO/DATE: 1-24155 20010801; FIRST REGISTRATION: LI 55218 01, 55218 02 20001214
0592438	C00592438/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0592438	02C0013	France		PRODUCT NAME: ELETRIPTAN HYDROBROMIDE; NAT. REGISTRATION NO/DATE: NL 26625 20011105; FIRST REGISTRATION: LI - IKS 55218 20001214
0592438	SPC/GB01/023	United Kingdom		PRODUCT NAME: ELETRIPTAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE HYDROBROMIDE SALT; REGISTERED: CH 55218 01 20001214; CH 52218 02 20001214; CH 52218 03 20001214; UK PL 00057/0452 20010212; UK PL 00057/0453 20010212; UK PL 00057/0454 20010212

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: RELPAX

Last updated: July 27, 2025

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Introduction

RELPAX (eletriptan hydrobromide) is a branded medication designed for the acute treatment of migraine attacks with or without aura. Approved by the U.S. Food and Drug Administration (FDA) in 2003, RELPAX is a member of the triptan class, which acts as selective serotonin receptor agonists to alleviate migraine symptoms. Over recent years, the drug's market performance and financial trajectory have been shaped by evolving market dynamics, competitive landscape, regulatory environment, and shifting healthcare priorities. This analysis provides a comprehensive overview of these factors, projecting future financial prospects and strategic considerations.

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Market Dynamics

1. Rising Global Burden of Migraine

Migraine remains a significant global health challenge, with the World Health Organization ranking it among the top neurological disorders, affecting approximately 1 billion individuals worldwide [1]. The disease's episodic nature and substantial disability burden drive continuous demand for effective acute treatments like RELPAX.

2. Competitive Landscape

RELPAX operates within a highly competitive market, dominated by generics and novel therapeutics. Its primary competitors include other triptans such as sumatriptan, rizatriptan, and zolmitriptan, along with newer drug classes like CGRP (calcitonin gene-related peptide) antagonists (e.g., erenumab, fremanezumab). The introduction of these novel agents has been a double-edged sword—providing effective alternatives but also fragmenting the market share for traditional triptans like RELPAX.

3. Patent and Regulatory Status

RELPAX benefits from a patent expiring in the late 2020s in key markets, with patent expiration opening pathways for generic competitors. The expiration timeline impacts pricing and market share, generally leading to significant revenue decline upon entry of generics [2].

4. Prescriber and Patient Preferences

The shift towards personalized medicine and newer delivery formats—such as nasal sprays, auto-injectors, and oral formulations—has influenced prescribing behaviors. While RELPAX remains favored among certain patient cohorts due to its efficacy and tolerability, the increased availability of alternative therapies affects its market positioning.

5. Pricing and Reimbursement Dynamics

Pricing strategies and reimbursement policies substantially influence RELPAX's market penetration. Favorable coverage by insurers in developed markets enhances patient access, whereas payers' cost-containment efforts often favor generic options, exerting downward pressure on revenue streams.

6. Impact of COVID-19 Pandemic

The pandemic affected healthcare delivery, with reduced outpatient visits and elective procedures which, indirectly, impacted migraine patient management and prescription patterns. However, the rise of telemedicine has somewhat mitigated these effects, facilitating continued prescriptions of acute migraine treatments like RELPAX.

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Financial Trajectory

1. Revenue Trends

Historically, RELPAX experienced steady revenue growth, driven by its clinical efficacy and relative preference among neurologists. However, patent expiration and increased competition from generics and branded CGRP antagonists have led to notable revenue erosion, a trend observed in similar branded pharmaceuticals [3].

2. Patent Expiry and Generic Competition

Anticipated generic entry following patent expiry is the most significant inflection point impacting RELPAX's revenue. Generic versions tend to underprice branded formulations, leading to a sharp decline in sales. Pharmaceutical companies often respond with strategies such as legal challenges, formulations differentiation, or line extensions to sustain revenue.

3. Strategic Alliances and Market Penetration

Partnerships with distributors and targeted marketing efforts aim to preserve RELPAX's market share. Nonetheless, market penetration faces headwinds from the increasing adoption of newer therapies with better safety or administration profiles, such as CGRP inhibitors—a class that offers preventive treatment options rather than acute relief.

4. Pricing Strategies

Companies often implement tiered pricing, rebates, and co-pay assistance programs to retain market share. The impending generic competition pressures these strategies, with manufacturers possibly reducing prices and offering discounts to maintain volume.

5. Future Revenue Projections

Considering patent expiration, the revenue trajectory for RELPAX is projected to decline over the next 3-5 years. However, with potential line extensions—such as new formulations or combination therapies—and expanding indications, there remains a possibility of partial revenue stabilization. The overall outlook suggests a contraction, typical for branded pharmaceuticals approaching patent expiry unless innovative strategies are employed.

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Market Opportunities and Challenges

Opportunities:

• Development of novel formulations, such as nasal sprays or rapid-onset subcutaneous options, could rejuvenate market interest.

• Expansion into emerging markets offers growth avenues, contingent on regulatory approval and localized pricing.

• Combining RELPAX with preventive therapies or exploring fixed-dose combinations could expand indications.

Challenges:

• Intense competition from generics post-patent expiry diminishes profitability.

• The advent of new therapeutics, especially CGRP antagonists, shifts market dynamics toward preventive strategies.

• Cost containment policies by healthcare payers pressure pricing models.

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Regulatory and Technological Impacts

Regulatory bodies increasingly demand evidence of safety, efficacy, and cost-effectiveness—potentially delaying approval for line extensions and new formulations. Moreover, technological advances in digital health are shaping patient engagement and adherence, indirectly influencing drug utilization.

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Conclusion

RELPAX's market dynamics are primarily governed by patent timelines, competitive force fields, and evolving therapeutic landscapes. Its financial trajectory reflects these influences, with near-term revenue likely to decline due to generic competition. Strategic innovations, market expansion, and reformulation efforts could mitigate decline and support sustained revenue streams.

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Key Takeaways

• The impending patent expiration in the late 2020s will considerably impact RELPAX's revenue, necessitating strategic adaptation.

• Competitive pressure from generics and CGRP therapeutics demands innovation in formulations and indications to maintain market relevance.

• Expansion into emerging markets offers growth potential, but requires navigating regulatory and reimbursement hurdles.

• Price competition will intensify post-patent expiry, emphasizing the importance of value-based pricing and patient adherence initiatives.

• Sustained success hinges on embracing technological integration and exploring combination therapies to address unmet needs within migraine management.

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FAQs

1. When is RELPAX expected to face generic competition?
The drug's patent is scheduled to expire in the late 2020s, after which generic copies are expected to enter the market, significantly impacting revenue.

2. How does RELPAX compare to newer migraine therapies like CGRP antagonists?
While RELPAX provides rapid relief for acute attacks, CGRP antagonists primarily serve as preventive treatments, and some newer formulations offer improved tolerability and onset of action, influencing prescriber preferences.

3. What strategies can pharmaceutical companies employ to sustain RELPAX’s market share post-patent expiry?
Options include developing new formulations, exploring combination therapies, expanding into new markets, engaging in value-based pricing, and leveraging digital health tools for better patient engagement.

4. Are there ongoing clinical developments for RELPAX?
Currently, focus remains on patent protection, marketing, and potential line extensions. No major new indications or formulations are publicly announced as of now.

5. How has the COVID-19 pandemic impacted RELPAX sales?
The pandemic initially disrupted outpatient care and prescription patterns; however, increased telemedicine use has helped sustain prescribing rates for acute migraine treatments like RELPAX.

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References

[1] World Health Organization. (2019). "Migraine Fact Sheet."
[2] U.S. Food and Drug Administration. (2020). "Patent Status for Eletriptan."
[3] IQVIA. (2022). "Pharmaceutical Market Data Report."