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Last Updated: December 22, 2024

NARATRIPTAN Drug Patent Profile


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Which patents cover Naratriptan, and when can generic versions of Naratriptan launch?

Naratriptan is a drug marketed by Ani Pharms, Apotex Corp, Aurobindo Pharma Usa, Chartwell Rx, Heritage, Hikma, Orbion Pharms, Padagis Us, and Sun Pharm Inds Ltd. and is included in nine NDAs.

The generic ingredient in NARATRIPTAN is naratriptan hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.

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Drug patent expirations by year for NARATRIPTAN
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Recent Clinical Trials for NARATRIPTAN

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

SponsorPhase
AgoneX Biopharmaceuticals, Inc.Phase 2
BioHealthonomics Inc.Phase 2
Ache Laboratorios Farmaceuticos S.A.Phase 3

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US Patents and Regulatory Information for NARATRIPTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 078751-001 Jul 7, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 090288-001 Jul 7, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex Corp NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 091373-002 Apr 22, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 090381-002 Jul 7, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 090288-002 Jul 7, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NARATRIPTAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naratriptan

Introduction to Naratriptan

Naratriptan, marketed under the brand name Amerge, is a triptan class drug used for the acute treatment of migraine attacks. It works by constricting blood vessels in the brain and blocking pain pathways, making it an effective option for managing migraine symptoms.

Market Size and Growth Projections

The naratriptan hydrochloride market is poised for significant growth over the forecast period of 2023 to 2031. The market is expected to expand due to several key factors, including the increasing prevalence of migraines and the efficacy of naratriptan in treating these conditions.

  • Market Segmentation: The naratriptan hydrochloride market is segmented based on type (less than 98%, 98% to 99%, more than 99%) and application (biopharmaceutical, laboratory, others), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1].

Drivers of Market Growth

Several drivers are contributing to the growth of the naratriptan hydrochloride market:

High Prevalence of Migraines

The high prevalence of migraines, particularly in regions like North America, is a significant driver. In the United States, for example, 17.1% of women and 5.6% of men report having migraine symptoms, creating a large target population for migraine therapeutics[3][4].

Efficacy and Cost-Effectiveness

Naratriptan has been shown to be highly effective in reducing migraine symptoms and is also cost-effective. Studies have indicated that naratriptan leads to significant reductions in symptom duration and lost productivity, resulting in overall savings despite the increase in drug costs[2].

Regulatory Approvals and Product Launches

Recent approvals and launches of new migraine therapeutics, including those in the triptan class, are driving market growth. For instance, approvals such as VYEPTI (eptinezumab-jjmr) and NURTEC ODT (rimegepant 75 mg) have boosted the market segment[3][4].

Market Trends

Dominance of Triptans

The triptans segment, which includes naratriptan, is expected to grow at a healthy CAGR due to their higher efficacy compared to other classes of migraine drugs like ditans and gepants. New product launches, such as REYVOW (lasmiditan), further support this trend[4].

Geographical Dominance

North America is expected to hold a significant share of the market due to the high prevalence of migraines and the increasing adoption of novel therapeutics in the region. Asia-Pacific is also emerging as a fast-growing market[3][4].

Financial Impact

Cost Savings

The use of naratriptan can lead to significant cost savings. For example, in Canada, naratriptan resulted in an annual reduction in symptom duration of 225 hours and savings of Can $390 in lost productivity, exceeding the increase in drug costs[2].

Economic Impact of Rx-to-OTC Switch

Studies have also explored the economic impact of switching triptans from prescription-only to over-the-counter (OTC) status. In six EU countries, such a switch was estimated to save €75 million annually from the third-party payer perspective and add €86 million from the societal perspective due to reduced absenteeism and improved productivity[5].

Key Players and Market Competition

The naratriptan hydrochloride market includes several key players such as GLR Innovations, Biorbyt Ltd, Targetmol, Merck, and others. These companies are profiled based on their product offerings and market-related factors, including the year of market entry[1].

Challenges and Restraints

While the market is poised for growth, there are also challenges to consider:

Regulatory Hurdles

Switching from prescription to OTC status involves regulatory hurdles and the need to ensure safety for undiagnosed patients. Serious adverse events, such as cardiovascular events, must be considered in such transitions[5].

Competition from Other Therapeutics

The market is competitive, with other classes of drugs like ditans and gepants also available. However, the higher efficacy of triptans is expected to maintain their market share[4].

Future Outlook

The future outlook for the naratriptan hydrochloride market is promising, driven by the increasing demand for effective migraine treatments and the ongoing development of new products within the triptan class.

"The use of naratriptan in the treatment of migraine is an economically attractive option, leading to savings in overall costs. Increases in drug costs seem acceptable in light of reductions in symptom duration."[2]

Key Takeaways

  • The naratriptan hydrochloride market is expected to grow significantly from 2023 to 2031.
  • High prevalence of migraines, especially in North America, drives market growth.
  • Naratriptan is cost-effective and leads to significant reductions in symptom duration and lost productivity.
  • Regulatory approvals and new product launches in the triptan class support market expansion.
  • North America is expected to dominate the market, with Asia-Pacific emerging as a fast-growing region.

FAQs

What is naratriptan used for?

Naratriptan is used for the acute treatment of migraine attacks. It works by constricting blood vessels in the brain and blocking pain pathways.

How does naratriptan impact the economy?

Naratriptan can lead to significant cost savings by reducing symptom duration and lost productivity, thereby offsetting the increase in drug costs.

Which region dominates the naratriptan hydrochloride market?

North America is expected to dominate the naratriptan hydrochloride market due to the high prevalence of migraines and the increasing adoption of novel therapeutics.

What are the challenges in switching naratriptan to OTC status?

Switching naratriptan to OTC status involves regulatory hurdles and the need to ensure safety for undiagnosed patients, particularly considering serious adverse events like cardiovascular events.

Who are the key players in the naratriptan hydrochloride market?

Key players include GLR Innovations, Biorbyt Ltd, Targetmol, Merck, and several other companies involved in the production and distribution of naratriptan hydrochloride.

Sources

  1. Market Research Intellect: Naratriptan Hydrochloride Market Size, Scope And Forecast Report.
  2. PubMed: Treatment of migraine in Canada with naratriptan: a cost-effectiveness analysis.
  3. Mordor Intelligence: Migraine Therapeutics Market Size & Share Analysis.
  4. Mordor Intelligence: Global Migraine Therapeutics Market Trends.
  5. PLOS ONE: Economic Impact of a triptan Rx-To-OTC Switch in Six EU Countries.

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