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Last Updated: March 16, 2025

ALMOTRIPTAN MALATE Drug Patent Profile


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When do Almotriptan Malate patents expire, and what generic alternatives are available?

Almotriptan Malate is a drug marketed by Ajanta Pharma Ltd, Mylan, and Teva Pharms Usa. and is included in three NDAs.

The generic ingredient in ALMOTRIPTAN MALATE is almotriptan malate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Almotriptan Malate

A generic version of ALMOTRIPTAN MALATE was approved as almotriptan malate by TEVA PHARMS USA on July 7th, 2015.

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Drug patent expirations by year for ALMOTRIPTAN MALATE
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Recent Clinical Trials for ALMOTRIPTAN MALATE

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SponsorPhase
Janssen-Ortho LLCPhase 4
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Phase 4
Ortho-McNeil Neurologics, Inc.Phase 4

See all ALMOTRIPTAN MALATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ALMOTRIPTAN MALATE
Paragraph IV (Patent) Challenges for ALMOTRIPTAN MALATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AXERT Tablets almotriptan malate 6.25 mg and 12.5 mg 021001 1 2005-12-08

US Patents and Regulatory Information for ALMOTRIPTAN MALATE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Mylan ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 205171-001 Nov 9, 2015 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Mylan ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 205171-002 Nov 9, 2015 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ajanta Pharma Ltd ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 205523-001 Mar 3, 2016 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ajanta Pharma Ltd ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 205523-002 Mar 3, 2016 AB RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Almotriptan Malate

Overview of Almotriptan Malate

Almotriptan malate, known by its brand name Axert, is a selective serotonin receptor agonist used for the acute treatment of migraine headaches in adults and teenagers. It belongs to the class of medications called triptans, which work by narrowing blood vessels in the brain and stopping pain signals[1][2].

Market Size and Growth

The global market for almotriptan malate is expected to exhibit steady growth driven by the increasing prevalence of migraines and the demand for effective acute treatments. The GCC Countries Almotriptan Malate API market, for instance, is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.5% during the forecast period, indicating a robust market expansion[4].

Key Market Drivers

Increasing Prevalence of Migraines

The rising incidence of migraines globally is a significant driver for the almotriptan malate market. Migraines affect a substantial portion of the population, and the need for effective treatments is driving the demand for triptans like almotriptan malate.

Advancements in Pharmaceutical Technology

Continuous advancements in pharmaceutical technology and manufacturing processes are improving the production efficiency and quality of almotriptan malate. This has led to a more stable and reliable supply chain, supporting market growth.

Regulatory Approvals

Almotriptan malate has received approvals in multiple regions, including the US and other global markets. These regulatory approvals are crucial for expanding the market reach and ensuring the drug's availability to a broader patient population[1][2].

Market Challenges

Competition from Other Triptans

The market for triptans is competitive, with several other drugs like sumatriptan, zolmitriptan, and eletriptan available. This competition can impact the market share of almotriptan malate, although its specific efficacy and safety profile help it maintain a significant position[3].

Side Effects and Contraindications

Almotriptan malate has several side effects and contraindications, such as cardiovascular risks, which can limit its use in certain patient groups. This necessitates careful patient selection and monitoring, potentially affecting market dynamics[2].

Generic Competition

The expiration of patents for almotriptan malate has led to the entry of generic versions into the market. While generics can increase accessibility, they also reduce the revenue generated by the branded version, impacting the financial trajectory of the original manufacturer[1].

Financial Trajectory

Revenue Trends

The revenue from almotriptan malate has been stable, driven by its established position in the migraine treatment market. However, the introduction of generic versions has led to a decline in revenue for the branded product. For example, the revenue from Axert (almotriptan malate) has decreased as generic alternatives have become available[1].

Cost and Pricing

The cost of almotriptan malate can vary based on the region and the presence of generic alternatives. In general, the pricing strategy for almotriptan malate is competitive with other triptans, reflecting its efficacy and safety profile. The cost-effectiveness of almotriptan malate compared to other treatments also influences its market position[3].

Market Share

Almotriptan malate maintains a significant market share within the triptan class due to its clinical efficacy and patient preference. However, the market share can fluctuate based on the availability of new treatments and changes in prescribing patterns.

Regional Market Analysis

Global Market

The global market for almotriptan malate is diverse, with different regions exhibiting varying growth rates. The GCC Countries, for example, are expected to show a CAGR of 6.5%, while other regions may have different growth trajectories based on local healthcare systems and regulatory environments[4].

US Market

In the US, almotriptan malate is approved and widely used for the acute treatment of migraines. The US market is significant due to the high prevalence of migraines and the well-established healthcare system that supports the use of prescription medications like almotriptan malate[2].

Future Outlook

Emerging Markets

Emerging markets, particularly in Asia and Latin America, offer significant growth opportunities for almotriptan malate. Increasing healthcare spending and improving access to medications in these regions are expected to drive market expansion.

Innovative Formulations

Research into new formulations and delivery methods for almotriptan malate could enhance patient compliance and efficacy, potentially boosting market growth. For instance, developments in oral formulations or combination therapies could offer competitive advantages.

Regulatory and Reimbursement Environment

Changes in regulatory policies and reimbursement structures can significantly impact the market dynamics for almotriptan malate. Favorable regulatory environments and reimbursement policies can increase access and affordability, driving market growth.

"Compared with placebo, triptans resolved pain at 2 hours and 1 day, and increased the risk of mild and transient adverse events (high strength of the body of evidence [SOE])[3]."

Key Takeaways

  • Market Growth: The almotriptan malate market is expected to grow, driven by the increasing prevalence of migraines and demand for effective treatments.
  • Competition: The market is competitive with other triptans, and generic competition affects revenue.
  • Financial Trajectory: Revenue has been stable but is impacted by generic versions and competitive pricing.
  • Regional Analysis: Different regions show varying growth rates, with emerging markets offering significant opportunities.
  • Future Outlook: Innovations in formulations and favorable regulatory environments are crucial for future market growth.

FAQs

What is almotriptan malate used for?

Almotriptan malate is used for the acute treatment of migraine headaches in adults and teenagers. It is not used to prevent migraines or treat other types of headaches[1][2].

How does almotriptan malate work?

Almotriptan malate works by narrowing blood vessels in the brain and stopping pain signals. It is a selective serotonin receptor agonist, specifically targeting 5-HT1B and 5-HT1D receptors[1].

What are the common side effects of almotriptan malate?

Common side effects include burning, numbness, prickly, or tingling feelings, dizziness, dry mouth, headache, nausea, and sleepiness. Serious side effects can include cardiovascular risks and serotonin syndrome when taken with certain other medications[2].

Can almotriptan malate be used in patients with heart disease?

Almotriptan malate should be used with caution in patients with heart disease. It may increase the risk of heart attack, angina, or stroke, especially in patients with a history of these conditions[2].

Is almotriptan malate available in generic form?

Yes, almotriptan malate is available in generic form, which has impacted the revenue generated by the branded version[1].

What is the projected market growth for almotriptan malate in GCC countries?

The GCC Countries Almotriptan Malate API market is projected to grow at a CAGR of 6.5% during the forecast period[4].

Sources

  1. DrugBank: Almotriptan: Uses, Interactions, Mechanism of Action.
  2. Mayo Clinic: Almotriptan (oral route).
  3. AHRQ: Acute Treatments for Episodic Migraine.
  4. Cognitive Market Research: Almotriptan Malate API Market Report 2024 (Global Edition).

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