Pilocarpine Hydrochloride Patent Expiration

Pilocarpine Hydrochloride is Used for correcting age-related loss of near vision (presbyopia). It was first introduced by Alcon Laboratories Inc in its drug Pilopine Hs on Oct 1, 1984. Other drugs containing Pilocarpine Hydrochloride are Isopto Carpine, Vuity, Qlosi, Salagen. 13 different companies have introduced drugs containing Pilocarpine Hydrochloride.


Pilocarpine Hydrochloride Patents

Given below is the list of patents protecting Pilocarpine Hydrochloride, 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
Qlosi US10639297 Ophthalmic pharmaceutical compositions and uses relating thereto Aug 18, 2037 Orasis Pharms
Qlosi US11129812 Ophthalmic pharmaceutical compositions and uses relating thereto Aug 18, 2037 Orasis Pharms
Qlosi US9867810 Ophthalmic pharmaceutical compositions and uses relating thereto Aug 18, 2037 Orasis Pharms
Vuity US10610518 Presbyopia treatments Apr 24, 2039 Abbvie
Vuity US11285134 Presbyopia treatments Apr 24, 2039 Abbvie


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 Pilocarpine Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Pilocarpine Hydrochloride.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 4th Yr, Small Entity 25 Oct, 2023 US10639297
Payment of Maintenance Fee, 4th Year, Large Entity 14 Sep, 2023 US10610518
Patent Issue Date Used in PTA Calculation 29 Mar, 2022 US11285134
Recordation of Patent Grant Mailed 29 Mar, 2022 US11285134
Email Notification 10 Mar, 2022 US11285134
Issue Notification Mailed 09 Mar, 2022 US11285134
Dispatch to FDC 01 Mar, 2022 US11285134
Mail Post Card 23 Feb, 2022 US11285134
Issue Fee Payment Received 17 Feb, 2022 US11285134
Issue Fee Payment Verified 17 Feb, 2022 US11285134



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Pilocarpine Hydrochloride Generics

Several generic applications have been filed for Pilocarpine Hydrochloride. The first generic version for Pilocarpine Hydrochloride was by Padagis Us Llc and was approved on Nov 16, 2004. And the latest generic version is by Amneal Eu Ltd and was approved on Sep 21, 2020.

Given below is the list of companies who have filed for Pilocarpine Hydrochloride generic.


1. AMNEAL

Amneal Eu Ltd has filed for 3 different strengths of generic version for Pilocarpine Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2% solution Prescription OPHTHALMIC AT Sep 21, 2020
1% solution Prescription OPHTHALMIC AT Sep 21, 2020
4% solution Prescription OPHTHALMIC AT Sep 21, 2020


2. RISING

Rising Pharma Holdings Inc has filed for 3 different strengths of generic version for Pilocarpine Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1% solution Prescription OPHTHALMIC AT Sep 27, 2017
2% solution Prescription OPHTHALMIC AT Sep 27, 2017
4% solution Prescription OPHTHALMIC AT Sep 27, 2017


3. IMPAX LABS

Impax Laboratories Inc has filed for 2 different strengths of generic version for Pilocarpine Hydrochloride. Given below are the details of the strengths of this generic introduced by Impax Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7.5MG tablet Prescription ORAL AB Mar 31, 2006
5MG tablet Prescription ORAL AB Mar 31, 2006


4. LANNETT CO INC

Lannett Co Inc has filed for 2 different strengths of generic version for Pilocarpine Hydrochloride. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Oct 14, 2005
7.5MG tablet Prescription ORAL AB May 6, 2009


5. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Pilocarpine Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Aug 13, 2019
7.5MG tablet Prescription ORAL AB Aug 13, 2019


6. SOMERSET THERAPS LLC

Somerset Therapeutics Llc has filed for 3 different strengths of generic version for Pilocarpine Hydrochloride. Given below are the details of the strengths of this generic introduced by Somerset Theraps Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1% solution Prescription OPHTHALMIC AT Nov 25, 2019
2% solution Prescription OPHTHALMIC AT Nov 25, 2019
4% solution Prescription OPHTHALMIC AT Nov 25, 2019


7. PADAGIS US

Padagis Us Llc has filed for 1 generic for Pilocarpine Hydrochloride. Given below are the details of the strengths of this generic introduced by Padagis Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Nov 16, 2004


8. INNOGENIX

Innogenix Llc has filed for 2 different strengths of generic version for Pilocarpine Hydrochloride. Given below are the details of the strengths of this generic introduced by Innogenix.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Dec 22, 2004
7.5MG tablet Prescription ORAL AB Feb 27, 2007