Zolmitriptan - Generic Drug Details

What are the generic sources for zolmitriptan and what is the scope of patent protection?

Zolmitriptan is the generic ingredient in three branded drugs marketed by Padagis Israel, Amneal, Alembic, Apotex Inc, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Rising, Zydus Pharms Usa Inc, Astrazeneca, Ajanta Pharma Ltd, Ani Pharms, Aurobindo Pharma, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Somerset Theraps Llc, Sun Pharma Global, Zydus Pharms, and IPR, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for zolmitriptan. Twenty-two suppliers are listed for this compound.

Summary for zolmitriptan

US Patents:	0
Tradenames:	3
Applicants:	21
NDAs:	26
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	23
Patent Applications:	6,640
Drug Prices:	Drug price trends for zolmitriptan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for zolmitriptan
What excipients (inactive ingredients) are in zolmitriptan?	zolmitriptan excipients list
DailyMed Link:	zolmitriptan at DailyMed

See drug prices for zolmitriptan

Recent Clinical Trials for zolmitriptan

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

Sponsor	Phase
Parc de Salut Mar	Phase 1
Food and Drug Administration (FDA)	Phase 1
William Stoops	Early Phase 1

See all zolmitriptan clinical trials

Pharmacology for zolmitriptan

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 zolmitriptan

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

Paragraph IV (Patent) Challenges for ZOLMITRIPTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOMIG	Nasal Spray	zolmitriptan	2.5 mg/spray	021450	1	2016-06-09
ZOMIG	Nasal Spray	zolmitriptan	5 mg/spray	021450	1	2013-11-14

US Patents and Regulatory Information for zolmitriptan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	ZOLMITRIPTAN	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	202855-001	Sep 20, 2019		DISCN	No	No
Macleods Pharms Ltd	ZOLMITRIPTAN	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	204336-002	Oct 22, 2015		DISCN	No	No
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	AB	RX	Yes	Yes
Ajanta Pharma Ltd	ZOLMITRIPTAN	zolmitriptan	TABLET;ORAL	204041-001	May 20, 2016	AB	RX	No	No
Macleods Pharms Ltd	ZOLMITRIPTAN	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	204336-001	Oct 22, 2015		DISCN	No	No

Expired US Patents for zolmitriptan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-002	Nov 25, 1997	5,466,699*PED
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	7,220,767*PED
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-001	Nov 25, 1997	5,863,935*PED
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-003	Sep 16, 2013	6,750,237*PED
Astrazeneca	ZOMIG-ZMT	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	021231-002	Sep 17, 2001	5,466,699*PED

Zolmitriptan Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zolmitriptan

Introduction

Zolmitriptan, a member of the triptan class of drugs, is widely used for the management of migraine attacks. Understanding the market dynamics and financial trajectory of zolmitriptan is crucial for pharmaceutical companies, investors, and healthcare providers.

Global Market Size and Growth

The global zolmitriptan market is anticipated to experience steady growth over the coming years. According to market reports, the zolmitriptan market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031, with its valuation estimated to increase significantly during this period[4].

Market Segmentation

The zolmitriptan market is segmented based on several factors, including application, product type, and geographical regions.

Application

The market is categorized into tablets, capsules, and other forms. Tablets are a dominant segment due to their ease of use and high bioavailability[4].

Product Type

Zolmitriptan products are classified as above 98% and below 98% purity. The above 98% segment is expected to hold a significant market share due to its higher efficacy and compliance with regulatory standards[4].

Geographical Regions

The market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America is a key revenue-generating region, driven by the presence of major pharmaceutical companies and favorable reimbursement policies[3][4].

Drivers of Growth

Several factors are driving the growth of the zolmitriptan market:

Increasing Incidence of Migraines

The rising incidence of migraines globally is a significant driver. Migraines are becoming more prevalent, leading to an increased demand for effective treatments like zolmitriptan[3].

Novel Drug Classes

The introduction of new drug classes, such as calcitonin gene-related peptide (CGRP) monoclonal antibodies, is also driving growth. Although these are primarily preventive treatments, they contribute to the overall growth of the migraine drugs market, which includes zolmitriptan[3].

Rx-to-OTC Switch

The potential switch of zolmitriptan from prescription to over-the-counter (OTC) status could significantly impact the market. An Rx-to-OTC switch would provide early and convenient access to the drug, potentially reducing healthcare costs and improving patient outcomes[2].

Economic Impact of Rx-to-OTC Switch

A study examining the economic impact of an Rx-to-OTC switch for triptans in six EU countries found several benefits:

• Cost Savings: Estimated savings of €75 million annually from the third-party payer perspective and an additional €86 million from the societal perspective due to reduced GP and emergency room visits and improved worker productivity[2].

• Improved Access: Early access to effective therapies during the early onset of migraines, which is when medications are most effective[2].

However, there are also potential risks, such as excessive use or misuse without proper monitoring, which could mitigate these benefits[2].

Competitive Landscape

The zolmitriptan market is competitive, with several key players:

• Sun Pharmaceutical Industries
• Tapi Teva
• Venturepharm Group
• Tiantaishan Pharmaceutical

These companies are investing in research and development to enhance product efficacy and compliance with regulatory standards[4].

Regulatory Considerations

Zolmitriptan, like other triptans, is associated with potential cardiovascular and cerebrovascular risks. It is contraindicated in patients with known coronary artery disease (CAD) and requires periodic cardiovascular evaluations for continued use[5].

Financial Projections

The global migraine drugs market, which includes zolmitriptan, was valued at USD 2.91 billion in 2021 and is expected to reach USD 10.86 billion by 2030, growing at a CAGR of 15.6%[3].

Revenue Share

The pain-relieving medications segment, which includes zolmitriptan, remains the chief revenue-generating segment in the global migraine drugs market. The preventive medications segment, driven by CGRP monoclonal antibodies, is also expected to grow significantly[3].

Regional Analysis

North America is the key revenue-generating geographical segment, driven by favorable reimbursement policies, the presence of key market players, and rising awareness about different migraine medications[3].

Challenges and Restraints

Despite the growth potential, the zolmitriptan market faces several challenges:

• Safety Concerns: The risk of serious cardiovascular and cerebrovascular adverse events associated with triptan use is a significant concern[5].

• Competition: The market is highly competitive, with new drug classes and formulations entering the market, which can impact the market share of zolmitriptan[3].

Technological Trends

Research is ongoing to develop new action pathways such as CGRP-based receptor and ligand inhibition, corticotrophin receptor antagonism, and nitrous oxide inhibition. These advancements could influence the future market dynamics of zolmitriptan[3].

Consumer Behavior Analysis

Migraine sufferers often self-diagnose and self-manage their condition, which makes the availability of OTC triptans a cost-effective alternative. This consumer behavior supports the potential for an Rx-to-OTC switch to positively impact the market[2].

Key Takeaways

• The zolmitriptan market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031.
• The market is driven by increasing incidence of migraines, novel drug classes, and potential Rx-to-OTC switches.
• North America is a key revenue-generating region.
• Safety concerns and competition are significant challenges.
• Technological advancements in migraine treatments are ongoing.

FAQs

What is the expected CAGR of the zolmitriptan market from 2024 to 2031?

The zolmitriptan market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031[4].

Which region is expected to dominate the global zolmitriptan market?

North America is expected to remain the key revenue-generating geographical segment in the global zolmitriptan market[3].

What are the potential benefits of an Rx-to-OTC switch for zolmitriptan?

An Rx-to-OTC switch could provide early and convenient access to the drug, reduce healthcare costs, and improve worker productivity[2].

What are the safety concerns associated with zolmitriptan use?

Zolmitriptan is associated with potential cardiovascular and cerebrovascular risks, including coronary vasospasm and cerebrovascular events[5].

How does the competitive landscape of the zolmitriptan market look?

The market is competitive with key players such as Sun Pharmaceutical Industries, Tapi Teva, and Venturepharm Group, among others[4].

Sources

1. Global Zolmitriptan Market Report 2024 Edition - Cognitivemarketresearch.com
2. Economic Impact of a triptan Rx-To-OTC Switch in Six EU Countries - PLOS ONE
3. Migraine Drugs Market Is Expected to Witness Rapid Growth in Coming Years - Biospace.com
4. Global zolmitriptan market size and forecast 2 - Marketresearchintellect.com
5. N21-450S008 Zolmitriptan Clinical PREA - FDA.gov