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Last Updated: December 22, 2024

PHENTOLAMINE MESYLATE Drug Patent Profile


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When do Phentolamine Mesylate patents expire, and when can generic versions of Phentolamine Mesylate launch?

Phentolamine Mesylate is a drug marketed by Hikma and Precision Dose Inc and is included in two NDAs.

The generic ingredient in PHENTOLAMINE MESYLATE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Phentolamine Mesylate

A generic version of PHENTOLAMINE MESYLATE was approved as phentolamine mesylate by HIKMA on March 11th, 1998.

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Drug patent expirations by year for PHENTOLAMINE MESYLATE
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Recent Clinical Trials for PHENTOLAMINE MESYLATE

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SponsorPhase
University of AlbertaPhase 4
Cairo UniversityPhase 3
University of AlbertaN/A

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Pharmacology for PHENTOLAMINE MESYLATE
Medical Subject Heading (MeSH) Categories for PHENTOLAMINE MESYLATE

US Patents and Regulatory Information for PHENTOLAMINE MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma PHENTOLAMINE MESYLATE phentolamine mesylate INJECTABLE;INJECTION 040235-001 Mar 11, 1998 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Precision Dose Inc PHENTOLAMINE MESYLATE phentolamine mesylate INJECTABLE;INJECTION 207686-001 Jul 14, 2017 AP RX 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

PHENTOLAMINE MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Phentolamine Mesylate

Introduction to Phentolamine Mesylate

Phentolamine Mesylate is a small molecule drug developed by Novartis Pharma AG, targeting the adrenergic receptor. It has been in use since its global first approval in January 1951 and is utilized in various medical indications, including anesthesia, erectile dysfunction, mydriasis, night blindness, presbyopia, and vision disorders[3].

Market Size and Growth

The global Phentolamine Mesylate market is anticipated to experience steady growth over the coming years. As of the latest reports, the market was valued at a significant amount in 2023 and is expected to reach a higher valuation by 2030, witnessing a Compound Annual Growth Rate (CAGR) of around 3 to 5 percent[1][4].

Key Indications and Market Segments

Phentolamine Mesylate's diverse indications drive its market dynamics. Here are some of the key areas:

Anesthesia Reversal

Phentolamine Mesylate is widely used for reversing soft-tissue anesthesia, particularly in dental procedures. Products like OraVerse, which contain Phentolamine Mesylate, are indicated for reversing the effects of local anesthetics containing vasoconstrictors, allowing patients to return to normal sensation and function more quickly[5].

Erectile Dysfunction

The drug is also used in the treatment of erectile dysfunction (ED), often in combination with other active pharmaceutical ingredients such as alprostadil and papaverine. It is administered via intracavernosal and intracorporeal routes, improving blood flow to the penis and enhancing sexual function[2][3].

Other Medical Indications

Phentolamine Mesylate is used in various other medical conditions, including hypertensive emergencies, pheochromocytoma diagnosis, heart failure, and ophthalmic procedures for mydriasis. These multiple indications contribute to its robust market presence[2][3].

Competitive Landscape

The market for Phentolamine Mesylate operates within a competitive landscape dominated by several major pharmaceutical companies. Novartis AG, the originator of Phentolamine Mesylate, is a key player, along with other industry giants such as GSK Plc, AstraZeneca PLC, Pfizer Inc., and Sanofi. These companies are actively involved in research and development, targeting the adrenergic receptor for various therapeutic interventions[3].

Geographical Distribution

The development and approval of Phentolamine Mesylate are widespread across several countries. China, the United States, and Japan are among the leading countries in terms of drug development and approvals. China has the highest number of approved drugs targeting the adrenergic receptor, indicating a strong market presence in this region[3].

Clinical Trials and R&D

Phentolamine Mesylate continues to be a subject of ongoing research and clinical trials. As of recent data, there are numerous clinical trials and research activities focused on the adrenergic receptor, with 12,891 clinical trials conducted globally. This ongoing R&D activity ensures the drug remains relevant and potentially expands its therapeutic applications[3].

Financial Projections

The financial trajectory of Phentolamine Mesylate is positive, driven by its diverse indications and steady market growth. Here are some key financial projections:

  • Market Valuation: The global Phentolamine Mesylate market is expected to grow from its current valuation to a higher figure by 2030, with a CAGR of 3 to 5 percent[1][4].
  • Revenue Streams: The revenue is generated from various segments, including anesthesia reversal, erectile dysfunction treatment, and other medical indications.
  • Cost and Pricing: The cost of Phentolamine Mesylate can vary based on the formulation, dosage, and geographical location. However, it remains a competitive option due to its established efficacy and long history of use.

Regulatory Environment

Phentolamine Mesylate is subject to regulatory oversight, particularly in its nomination for inclusion on the 503B Bulks List by the FDA. This involves evaluations by the Food and Drug Administration (FDA) to determine its suitability for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act[2].

Conclusion

Phentolamine Mesylate's market dynamics are characterized by steady growth, driven by its multiple active indications and ongoing research. The drug's financial trajectory is positive, with projected growth in market valuation and continued relevance in various therapeutic areas.

Key Takeaways

  • Market Growth: Expected CAGR of 3 to 5 percent until 2030.
  • Diverse Indications: Used in anesthesia reversal, erectile dysfunction, mydriasis, and other medical conditions.
  • Competitive Landscape: Dominated by major pharmaceutical companies like Novartis AG, GSK Plc, and Pfizer Inc.
  • Geographical Presence: Strong market presence in China, the United States, and Japan.
  • Ongoing R&D: Active clinical trials and research activities targeting the adrenergic receptor.

FAQs

  1. What is Phentolamine Mesylate used for? Phentolamine Mesylate is used for various medical indications, including anesthesia reversal, erectile dysfunction, mydriasis, night blindness, presbyopia, and vision disorders.

  2. Who developed Phentolamine Mesylate? Phentolamine Mesylate was developed by Novartis Pharma AG.

  3. What is the expected market growth for Phentolamine Mesylate? The market is expected to grow at a CAGR of 3 to 5 percent until 2030.

  4. How is Phentolamine Mesylate administered for erectile dysfunction? It is administered via intracavernosal and intracorporeal routes, often in combination with other active pharmaceutical ingredients.

  5. Which companies are involved in the development and marketing of Phentolamine Mesylate? Major pharmaceutical companies such as Novartis AG, GSK Plc, AstraZeneca PLC, Pfizer Inc., and Sanofi are involved in its development and marketing.

Sources

  1. https://reports.valuates.com/market-reports/QYRE-Auto-10U18665/global-phentolamine-mesylate-injection
  2. https://archive.hshsl.umaryland.edu/bitstream/handle/10713/14950/Phentolamine_Final_2020_12.pdf
  3. https://synapse.patsnap.com/blog/exploring-phentolamine-mesylates-revolutionary-randd-successes
  4. https://www.marketresearchintellect.com/product/global-phentolamine-mesylate-market-size-and-forecast-2/
  5. https://www.henryschein.com/us-en/dental/p/anesthetics/anesthetic-reversal/oraverse/2282237

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