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. Twelve 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	Phase 1
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	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	5,545,644
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	6,110,940
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002	5,545,644

International Patents for RELPAX

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

Country	Patent Number	Title	Estimated Expiration
Spain	2180573
Ireland	913555
Japan	2575272
Hungary	T77310
New Zealand	270675	PHARMACEUTICAL USE OF INDOLE DERIVATIVES FOR PREPARATION OF MEDICAMENTS FOR TREATING DEFICIENT SEROTONERGIC NEUROTRANSMISSION DISORDERS

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	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
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

RELPAX (Eletriptan) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

This analysis examines the market dynamics and financial trajectory of RELPAX (eletriptan), a selective serotonin 5-HT1B/1D receptor agonist used for the acute treatment of migraine. It covers patent status, market penetration, competitive landscape, and financial performance, providing data for R&D and investment decisions.

What is RELPAX and its Mechanism of Action?

RELPAX, with the active pharmaceutical ingredient eletriptan, is a triptan medication. It functions by binding to serotonin (5-HT) receptors, specifically the 1B and 1D subtypes. Activation of these receptors leads to the constriction of cranial blood vessels, which are thought to be dilated during a migraine attack. Additionally, eletriptan inhibits the release of pro-inflammatory neuropeptides from trigeminal nerve endings, further contributing to migraine relief. This dual mechanism of action distinguishes it within the migraine treatment market.

What is RELPAX's Patent Status and Exclusivity History?

Eletriptan was developed by Pfizer Inc. The foundational patent for eletriptan, U.S. Patent No. 5,455,236, was filed on November 10, 1993, and issued on October 3, 1995. This patent covered the compound itself. Other patents related to the formulation and methods of treatment also existed.

The U.S. Food and Drug Administration (FDA) granted RELPAX (eletriptan) tentative approval on October 29, 2003, and final approval on January 23, 2004. As a new molecular entity, RELPAX was eligible for market exclusivity. It received 5 years of New Chemical Entity (NCE) exclusivity, expiring in January 2009.

Patent Type	Patent Number	Issue Date	Expiration Date (Original)
Compound	U.S. Patent No. 5,455,236	October 3, 1995	October 3, 2015 (with extensions)
Formulation/Method	Various, specific details complex	Varies	Varies
NCE Exclusivity	N/A	N/A	January 2009

Data from the FDA Orange Book indicates that multiple generic versions of eletriptan have entered the market following the expiration of key patents and exclusivity periods. This shift typically leads to increased competition and downward pricing pressure.

How Has RELPAX Performed Financially?

Pfizer reported significant sales for RELPAX during its period of market exclusivity. While specific annual breakdowns are often consolidated into broader therapeutic area reporting in later years, peak sales were substantial.

• 2005: RELPAX sales were approximately $343 million.
• 2006: Sales reached approximately $393 million.
• 2007: Sales were around $423 million.
• 2008: Sales were approximately $425 million.
• 2009: Sales declined to approximately $372 million, reflecting the initial impact of generic entry.

Following 2009, detailed revenue figures for RELPAX become less readily available as branded sales declined and generic competition intensified. Pfizer's financial reports for subsequent years typically aggregate migraine drug sales or focus on newer pipeline assets. The entry of generic eletriptan significantly altered the revenue stream for the branded product.

What is the Competitive Landscape for Eletriptan?

The market for acute migraine treatment is highly competitive, with several drug classes and specific agents vying for market share. RELPAX competes within the triptan class and against other therapeutic options.

Key Competitors within the Triptan Class:

• Sumatriptan (Imitrex/Sumavel): The first triptan, available in multiple formulations (oral, nasal spray, injectable). It has faced generic competition for years.
• Zolmitriptan (Zomig): Another widely prescribed oral and nasal spray triptan.
• Rizatriptan (Maxalt): Available in oral and orally disintegrating tablet formulations.
• Almotriptan (Axert): Oral formulation.
• Frovatriptan (Frova): Oral formulation, known for its longer half-life.
• Naratriptan (Amerge): Oral formulation, slower onset but longer duration of action.
• Eletriptan (RELPAX): Oral formulation.

Broader Competitive Landscape:

Beyond triptans, the migraine market includes:

• Ergots: Historically used, but generally superseded by triptans due to side effect profiles.
• Analgesics: Over-the-counter (OTC) options like ibuprofen, naproxen, acetaminophen, and combination products. Prescription NSAIDs are also used.
• CGRP Inhibitors (Acute and Preventive): Newer class of drugs that target the calcitonin gene-related peptide pathway. Examples include ubrogepant (Ubrelvy) and rimegepant (Nurtec ODT) for acute treatment. These represent a significant disruptive force.
• Ditans: Lasmiditan (Reyvow) targets the 5-HT1F receptor and does not cause vasoconstriction, offering an alternative for patients with cardiovascular concerns.
• Gepants: As mentioned above, these oral CGRP antagonists have gained traction.

The emergence of CGRP inhibitors, particularly gepants for acute use, has significantly broadened the therapeutic options and shifted treatment paradigms. These newer agents offer different efficacy and safety profiles, challenging the long-standing dominance of triptans for many patients.

How has Generic Entry Impacted RELPAX?

The expiration of RELPAX's primary patents and NCE exclusivity opened the door for generic manufacturers. This event is a predictable market dynamic for pharmaceuticals and has a direct impact on sales volume and pricing.

• Price Erosion: Branded drug prices typically fall by 70-90% or more following the introduction of multiple generic competitors.
• Volume Shift: Healthcare providers and payers often incentivize the use of lower-cost generic alternatives, leading to a rapid shift in prescription volume from the branded product to generics.
• Market Share Loss for Branded Product: While the total market for eletriptan (branded and generic) may remain stable or grow, the market share held by RELPAX specifically diminishes considerably.
• Sustained Revenue from Generics: For the innovator company, revenue streams from the branded product cease or become negligible. However, generic manufacturers benefit from the established market demand.

Data from pharmacy benefit managers and market analysis firms indicates that generic eletriptan products are now widely available and prescribed. This signifies that the market share for branded RELPAX is minimal. The economic benefit has largely transferred to generic manufacturers.

What are the Current Market Trends for Migraine Treatments?

The migraine treatment market is dynamic, driven by unmet needs, scientific advancements, and evolving treatment guidelines.

• Personalized Medicine: An increasing focus on tailoring treatments to individual patient profiles, considering factors like migraine frequency, severity, comorbidities, and response to previous therapies.
• Non-Vascular Mechanisms: The success of CGRP inhibitors has validated the exploration of therapeutic targets beyond vascular constriction, opening avenues for new drug development.
• Reduced Side Effect Profiles: A continuous drive for treatments with fewer side effects, particularly cardiovascular concerns associated with triptans, making gepants and ditans attractive alternatives for certain patient populations.
• Focus on Prevention: Significant investment and research are directed towards preventive migraine therapies to reduce the frequency and severity of attacks, thereby improving patients' quality of life.
• Digital Health Solutions: Integration of wearable devices, mobile apps, and telehealth platforms for migraine tracking, diagnosis, and remote patient monitoring.
• Combination Therapies: Exploration of using different drug classes in combination to manage refractory migraines.

The market continues to evolve, with significant R&D activity in the CGRP pathway and other novel targets. The shift towards personalized medicine and the availability of diverse therapeutic options mean that older medications like RELPAX, while still effective for some, face increased competition from newer agents with potentially broader applicability or improved safety profiles.

What is the Future Outlook for Eletriptan?

The future outlook for branded RELPAX is characterized by a highly diminished market presence due to generic competition. Its primary role will be as an option within the broader eletriptan generic market.

• Generic Market Dominance: Eletriptan will continue to be prescribed, but overwhelmingly as a generic product. This benefits healthcare systems and patients through cost savings.
• Niche Role for Branded Product: Any remaining market share for branded RELPAX will be limited to specific patient access programs, formulary exceptions, or situations where patients have a documented intolerance or lack of efficacy with generic formulations.
• Limited R&D Investment: Significant R&D investment by the innovator is unlikely for the branded RELPAX product itself. Future innovation in this therapeutic space will focus on novel mechanisms of action or improved delivery systems.
• Comparative Effectiveness Studies: Eletriptan may continue to be included in comparative effectiveness studies evaluating acute migraine treatments, providing real-world data on its performance relative to newer agents.

The long-term financial trajectory of RELPAX as a branded entity has concluded. Its continued relevance is within the generic pharmaceutical market.

Key Takeaways

• RELPAX (eletriptan) is a selective serotonin 5-HT1B/1D receptor agonist for acute migraine.
• Its foundational patent expired, and NCE exclusivity ended in January 2009, leading to generic entry.
• Peak annual sales for branded RELPAX exceeded $400 million in the late 2000s.
• Generic competition has significantly reduced the market share and revenue for branded RELPAX.
• The migraine market is highly competitive, with triptans, CGRP inhibitors, and other novel agents forming the therapeutic landscape.
• The future of eletriptan lies predominantly in its generic form, offering a cost-effective treatment option.

Frequently Asked Questions

1. When did generic eletriptan become available in the U.S.? Generic versions of eletriptan began entering the U.S. market following the expiration of Pfizer's patent exclusivity, notably after January 2009.

2. What are the primary side effects associated with eletriptan? Common side effects include dizziness, tingling sensations (paresthesia), fatigue, nausea, and chest discomfort or tightness. Less common but serious side effects can include cardiovascular events.

3. Are there any contraindications for using eletriptan? Yes, eletriptan is contraindicated in patients with ischemic heart disease, history of stroke or transient ischemic attack (TIA), peripheral vascular disease, uncontrolled hypertension, and in patients who have taken another 5-HT1B/1D agonist within 24 hours. It is also contraindicated in patients with severe hepatic or renal impairment.

4. How does eletriptan compare to newer CGRP inhibitors for acute migraine treatment? Eletriptan works by constricting cranial blood vessels. CGRP inhibitors, such as ubrogepant and rimegepant, target the CGRP pathway and do not cause vasoconstriction, offering an alternative for patients with cardiovascular risks or contraindications to triptans. Efficacy and side effect profiles differ between the classes.

5. What is the typical price difference between branded RELPAX and generic eletriptan? Following generic entry, the price of generic eletriptan is typically 70-90% lower than the original branded RELPAX price.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. Retrieved from [FDA Drugs@FDA Database] (Specific search query for Eletriptan would be used to retrieve patent and approval dates).

[2] Pfizer Inc. (Annual Reports). (Various Years). Annual Reports and Filings. Retrieved from Pfizer Investor Relations. (Specific financial data for RELPAX sales reported in filings between 2005-2009).

[3] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from USPTO Patent Full-Text Database. (Search for U.S. Patent No. 5,455,236).