Phentolamine mesylate - Generic Drug Details

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

Phentolamine mesylate is the generic ingredient in four branded drugs marketed by Septodont Holding, Hikma, Precision Dose Inc, Novartis, and Famygen Life Sci, and is included in five NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Phentolamine mesylate has twenty-four patent family members in sixteen countries.

There are three drug master file entries for phentolamine mesylate. Five suppliers are listed for this compound.

Summary for phentolamine mesylate

International Patents:	24
US Patents:	8
Tradenames:	4
Applicants:	5
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	16
Patent Applications:	1,613
Drug Prices:	Drug price trends for phentolamine mesylate
What excipients (inactive ingredients) are in phentolamine mesylate?	phentolamine mesylate excipients list
DailyMed Link:	phentolamine mesylate at DailyMed

See drug prices for phentolamine mesylate

Recent Clinical Trials for phentolamine mesylate

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

Sponsor	Phase
University of Alberta	Phase 4
Cairo University	Phase 3
University of Alberta	N/A

See all phentolamine mesylate clinical trials

Pharmacology for phentolamine mesylate

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

Medical Subject Heading (MeSH) Categories for phentolamine mesylate

Adrenergic alpha-Antagonists

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for phentolamine mesylate

C04AB	Imidazoline derivatives
C04A	PERIPHERAL VASODILATORS
C04	PERIPHERAL VASODILATORS
C	Cardiovascular system

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for PHENTOLAMINE MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYZUMVI	Ophthalmic Solution	phentolamine mesylate	0.75%	217064	1	2024-12-16

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
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	10,772,829		Y
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	11,090,261		Y
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	10,278,918		Y
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes	12,201,616
Novartis	REGITINE	phentolamine mesylate	INJECTABLE;INJECTION	008278-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for phentolamine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	6,764,678
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	7,575,757
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	7,569,230
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	6,872,390
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008	7,229,630

International Patents for phentolamine mesylate

Country	Patent Number	Title	Estimated Expiration
Canada	2899339	SOLUTIONS OPHTALMIQUES AQUEUSES DE PHENTOLAMINE ET UTILISATIONS MEDICALES ASSOCIEES (AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF)
World Intellectual Property Organization (WIPO)	2014121027
South Africa	202102488	METHODS AND COMPOSITIONS FOR TREATMENT OF PRESBYOPIA, MYDRIASIS, AND OTHER OCULAR DISORDERS
Australia	2019366451	Methods and compositions for treatment of presbyopia, mydriasis, and other ocular disorders
Japan	2016506966
European Patent Office	2950648	SOLUTIONS OPHTALMIQUES AQUEUSES DE PHENTOLAMINE ET UTILISATIONS MÉDICALES ASSOCIÉES (AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF)

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