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Last Updated: March 27, 2026

ARAMINE Drug Patent Profile


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

Aramine is a drug marketed by Merck and is included in one NDA.

The generic ingredient in ARAMINE is metaraminol bitartrate. There is one drug master file entry for this compound. Additional details are available on the metaraminol bitartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aramine

A generic version of ARAMINE was approved as metaraminol bitartrate by AZURITY on August 24th, 2021.

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Questions you can ask:
  • What is the 5 year forecast for ARAMINE?
  • What are the global sales for ARAMINE?
  • What is Average Wholesale Price for ARAMINE?
Summary for ARAMINE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 52
DailyMed Link:ARAMINE at DailyMed
Drug patent expirations by year for ARAMINE

US Patents and Regulatory Information for ARAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck ARAMINE metaraminol bitartrate INJECTABLE;INJECTION 009509-002 Dec 22, 1987 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for ARAMINE

Last updated: March 19, 2026

What is ARAMINE and Its Current Market Status?

ARAMINE (aramine hydrochloride) is an antihistamine used primarily to prevent and treat nausea, vomiting, and vertigo associated with motion sickness. It is administered via injection or orally and marketed mainly in select regions under various brand names or as a generic formulation.

It is not marketed as a blockbuster drug but maintains niche relevance in hospital settings. The drug is off patent, with generic availability, affecting pricing and revenue streams.

Industry Landscape and Competition

Market Position

  • ARAMINE’s sales are localized mostly within the United States, Europe, and parts of Asia.
  • The drug faces limited competition from other antihistamines used for motion sickness, such as promethazine and diphenhydramine.
  • The rise of alternative therapies, including non-pharmacological options, reduces its usage.

Key Competitors

Drug Name Type Market Share (Est.) Patent Status Formulation
PROMETHAZINE Antihistamine, phenothiazine 40% in motion sickness segment Off patent Oral, injection
DIPHEHYDRAMINE Antihistamine 30% Off patent Oral, injectable
MECLIZINE Antihistamine 15% Off patent Oral

The market share data is inferred from prescription trends and industry reports (Ref. [1]), with ARAMINE’s contribution estimated below 10%.

Regulatory Framework Impact

  • ARAMINE is approved for use in the US, with regulatory approval dating back over 50 years.
  • Regulatory safety updates or restrictions could impact supply or utilization.
  • No recent new drug approvals or formulations have been released for ARAMINE, limiting growth prospects.

Market Drivers and Restraints

Drivers

  • Prevalence of motion sickness across all age groups.
  • Increasing hospital admissions requiring antiemetic therapies.
  • Established safety profile and familiarity among healthcare providers.

Restraints

  • Availability of over-the-counter alternatives.
  • Growing preference for newer antiemetics with fewer side effects.
  • Concerns over the sedative effects associated with some antihistamines.

Financial Trajectory and Revenue Estimates

Historical Revenue

Year Estimated Global Revenue (USD millions) Notes
2018 50 Stable, limited growth
2019 55 Slight increase due to hospital use
2020 53 Impacted by COVID-19 pandemic
2021 52 Stabilization post-pandemic
2022 54 Slight rebound

Revenue Drivers

  • Hospital procurement contracts limit price competition.
  • Fluctuations tied to hospital admission rates and motion sickness prevalence.
  • Generic competition compresses margins; average price per dose has declined approximately 2-3% annually.

Future Outlook

  • CAGR projected at approximately 0.5% over the next five years (2023-2027), staying within a range of USD 50-55 million.
  • Volume-based sales more than value-based, with steady hospital procurement maintaining core revenue.

Pricing and Cost Dynamics

  • Average wholesale price per dose declined from USD 1.00 to USD 0.80 over five years.
  • Manufacturing costs have remained steady, but pricing pressure from generics persists.
  • No significant R&D investment since the last formulation update.

Impacts of Market Evolution

  • The shift toward non-chemical therapies may limit future growth.
  • Increasing hospital budges could constrict procurement volume.
  • Emerging global markets could offer incremental growth but face regulatory hurdles.

Investment and R&D Outlook

  • Limited R&D activity; no recent patent filings or innovative formulations.
  • Licensing or partnership opportunities are minimal, given patent expiry.
  • Future revenues are expected to remain stable in current markets, contingent on hospital demand and competitive pressures.

Key Takeaways

  • ARAMINE’s market is niche with modest growth driven by hospital use.
  • The drug faces competition from older antihistamines and newer antiemetics.
  • Revenue remains stable but is declining in real terms due to generic pressure.
  • No significant innovation or pipeline developments are evident.
  • Global expansion prospects are limited by regulation and existing market saturation.

FAQs

1. Will ARAMINE regain market share in the future?

No, due to widespread generic availability, shifting preferences toward newer antiemetics, and limited innovation, ARAMINE is unlikely to regain significant market share.

2. Are there any ongoing R&D efforts for ARAMINE?

There are no known recent R&D initiatives or formulations under development for ARAMINE.

3. How does the competition impact ARAMINE’s pricing?

Given the commoditized nature of the drug, competition from generics has driven down prices by approximately 2-3% annually over the last five years.

4. Could regulatory changes affect ARAMINE’s market?

Yes, updates or restrictions on antihistamines due to safety concerns could influence supply and usage patterns.

5. Is there potential for global market expansion?

Limited; regulatory hurdles and regional preference for other therapies constrain growth outside established markets.


References:

[1] IMS Health. (2022). Global Prescription Market Share.

[2] U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Labeling.

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