Phentolamine Mesylate Patent Expiration

Phentolamine Mesylate is Used for reversal of soft-tissue anesthesia following intraoral local anesthetic injection. It was first introduced by Novartis Pharmaceuticals Corp in its drug Regitine on Approved Prior to Jan 1, 1982. Other drugs containing Phentolamine Mesylate are Ryzumvi, Oraverse. 5 different companies have introduced drugs containing Phentolamine Mesylate.


Phentolamine Mesylate Patents

Given below is the list of patents protecting Phentolamine Mesylate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Oraverse US6764678 Local anesthetic methods and kits May 11, 2021

(Expired)

Septodont Holding
Oraverse US6872390 Local anesthetic methods and kits May 11, 2021

(Expired)

Septodont Holding
Oraverse US7229630 Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Jun 20, 2023

(Expired)

Septodont Holding
Oraverse US7569230 Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Oct 17, 2023

(Expired)

Septodont Holding
Oraverse US7575757 Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof Apr 21, 2025 Septodont Holding
Ryzumvi US10278918 Aqueous ophthalmic solutions of phentolamine and medical uses thereof Jan 31, 2034 Famygen Life Sci
Ryzumvi US10772829 Aqueous ophthalmic solutions of phentolamine and medical uses thereof Jan 31, 2034 Famygen Life Sci
Ryzumvi US11090261 Aqueous ophthalmic solutions of phentolamine and medical uses thereof Jan 31, 2034 Famygen Life Sci
Ryzumvi US11400077 Methods and compositions for treatment of presbyopia, mydriasis, and other ocular disorders Oct 25, 2039 Famygen Life Sci
Ryzumvi US11844858 Aqueous ophthalmic solutions of phentolamine and medical uses thereof Jan 31, 2034 Famygen Life Sci
Ryzumvi US9795560 Aqueous ophthalmic solutions of phentolamine and medical uses thereof Jan 31, 2034 Famygen Life Sci


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Phentolamine Mesylate's patents.

Given below is the list recent legal activities going on the following patents of Phentolamine Mesylate.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 4th Yr, Small Entity 15 Mar, 2024 US10772829
Electronic Review 02 Feb, 2024 US11844858
Email Notification 20 Dec, 2023 US11844858
Recordation of Patent Grant Mailed 19 Dec, 2023 US11844858
Patent Issue Date Used in PTA Calculation 19 Dec, 2023 US11844858
Recordation of Patent eGrant 19 Dec, 2023 US11844858
Mail Patent eGrant Notification 19 Dec, 2023 US11844858
Patent eGrant Notification 19 Dec, 2023 US11844858
Email Notification 30 Nov, 2023 US11844858
Issue Notification Mailed 29 Nov, 2023 US11844858



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Phentolamine Mesylate Generics

Several generic applications have been filed for Phentolamine Mesylate. The first generic version for Phentolamine Mesylate was by Hikma Pharmaceuticals Usa Inc and was approved on Mar 11, 1998. And the latest generic version is by Precision Dose Inc and was approved on Jul 14, 2017.

Given below is the list of companies who have filed for Phentolamine Mesylate generic.


1. PRECISION DOSE INC

Precision Dose Inc has filed for 1 generic for Phentolamine Mesylate. Given below are the details of the strengths of this generic introduced by Precision Dose Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/VIAL injectable Prescription INJECTION AP Jul 14, 2017


2. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Phentolamine Mesylate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/VIAL

(reference standard)

injectable Prescription INJECTION AP Mar 11, 1998