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
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 |
|---|---|---|---|---|
| Vuity | US10610518 | Presbyopia treatments | Apr 24, 2039 | Abbvie |
| Vuity | US11285134 | Presbyopia treatments | Apr 24, 2039 | Abbvie |
| 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 | US11974986 | 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 |
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.
Latest Legal Activities on Pilocarpine Hydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Pilocarpine Hydrochloride.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 Critical | 29 Mar, 2022 | US11285134 |
| Recordation of Patent Grant Mailed Critical | 29 Mar, 2022 | US11285134 |
| Email Notification Critical | 10 Mar, 2022 | US11285134 |
| Issue Notification Mailed Critical | 09 Mar, 2022 | US11285134 |
| Dispatch to FDC | 01 Mar, 2022 | US11285134 |
| Mail Post Card | 23 Feb, 2022 | US11285134 |
| Issue Fee Payment Received Critical | 17 Feb, 2022 | US11285134 |
| Issue Fee Payment Verified Critical | 17 Feb, 2022 | US11285134 |
Pilocarpine Hydrochloride's Family Patents
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Pilocarpine Hydrochloride Generic API Manufacturers
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 Apr 28, 2025.
Given below is the list of companies who have filed for Pilocarpine Hydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. AMNEAL
Amneal Eu Ltd has filed for 4 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 |
| 1.25% | solution | Prescription | OPHTHALMIC | AB | Apr 28, 2025 |
Manufacturing Plant Locations New
Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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2. 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 |
Manufacturing Plant Locations New
Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
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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. 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 |
Manufacturing Plant Locations New
Innogenix's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Innogenix as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
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5. 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 |
6. 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 |
Manufacturing Plant Locations New
Padagis Us's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Padagis Us as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
7. 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 |
Manufacturing Plant Locations New
Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Mexico |
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| India |
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8. 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 |