Levalbuterol Hydrochloride Patent Expiration
Levalbuterol Hydrochloride is Used for treating or preventing bronchospasm. It was first introduced by Hikma Pharmaceuticals Usa Inc
Levalbuterol Hydrochloride Patents
Given below is the list of patents protecting Levalbuterol 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 |
|---|---|---|---|---|
| Xopenex | US6451289 | Albuterol formulations |
Mar 21, 2021
(Expired) | Hikma |
| Xopenex | US5547994 | Method for treating asthma using optically pure R(-) albuterol |
Aug 20, 2013
(Expired) | Hikma |
| Xopenex | US5362755 | Method for treating asthma using optically pure (R)-albuterol |
Mar 25, 2013
(Expired) | Hikma |
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 Levalbuterol Hydrochloride's patents.
Latest Legal Activities on Levalbuterol Hydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Levalbuterol Hydrochloride.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 28 Feb, 2005 | US6451289 |
| Correspondence Address Change Critical | 06 Dec, 2004 | US6451289 |
| Post Issue Communication - Certificate of Correction | 24 Jul, 2003 | US6451289 |
| Post Issue Communication - Certificate of Correction Denied | 25 Feb, 2003 | US6451289 |
| Post Issue Communication - Certificate of Correction Denied | 19 Dec, 2002 | US6451289 |
| Recordation of Patent Grant Mailed Critical | 17 Sep, 2002 | US6451289 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Sep, 2002 | US6451289 |
| Issue Notification Mailed Critical | 29 Aug, 2002 | US6451289 |
| Application Is Considered Ready for Issue Critical | 16 Aug, 2002 | US6451289 |
| Workflow - Drawings Finished | 05 Aug, 2002 | US6451289 |
Levalbuterol Hydrochloride's Family Patents
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Levalbuterol Hydrochloride Generic API Manufacturers
Several generic applications have been filed for Levalbuterol Hydrochloride. The first generic version for Levalbuterol Hydrochloride was by Impax Laboratories Inc and was approved on Apr 9, 2008. And the latest generic version is by Mankind Pharma Ltd and was approved on Oct 21, 2024.
Given below is the list of companies who have filed for Levalbuterol Hydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. CIPLA
Cipla Ltd has filed for 3 different strengths of generic version for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.0103% BASE | solution | Prescription | INHALATION | AN | Dec 13, 2013 |
| EQ 0.042% BASE | solution | Prescription | INHALATION | AN | Dec 13, 2013 |
| EQ 0.021% BASE | solution | Prescription | INHALATION | AN | Dec 13, 2013 |
Manufacturing Plant Locations New
Cipla'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 Cipla as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||
2. IMPAX LABS INC
Impax Laboratories Inc has filed for 3 different strengths of generic version for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Impax Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.042% BASE | solution | Prescription | INHALATION | AN | Apr 9, 2008 |
| EQ 0.021% BASE | solution | Prescription | INHALATION | AN | Apr 9, 2008 |
| EQ 0.0103% BASE | solution | Prescription | INHALATION | AN | Apr 9, 2008 |
3. LUOXIN AUROVITAS
Luoxin Aurovitas Pharma Chengdu Co Ltd has filed for 4 different strengths of generic version for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Luoxin Aurovitas.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.021% BASE | solution | Prescription | INHALATION | AN | Dec 30, 2016 |
| EQ 0.0103% BASE | solution | Prescription | INHALATION | AN | Dec 30, 2016 |
| EQ 0.042% BASE | solution | Prescription | INHALATION | AN | Dec 30, 2016 |
| EQ 0.25% BASE | solution | Prescription | INHALATION | AN | Jan 31, 2017 |
4. MANKIND PHARMA
Mankind Pharma Ltd has filed for 3 different strengths of generic version for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Mankind Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.0103% BASE | solution | Prescription | INHALATION | AN | Oct 21, 2024 |
| EQ 0.021% BASE | solution | Prescription | INHALATION | AN | Oct 21, 2024 |
| EQ 0.042% BASE | solution | Prescription | INHALATION | AN | Oct 21, 2024 |
Manufacturing Plant Locations New
Mankind Pharma'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 Mankind Pharma as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| India |
| |||||
5. MYLAN SPECIALITY LP
Mylan Specialty Lp has filed for 1 generic for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Speciality Lp.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.25% BASE
(reference standard) | solution | Prescription | INHALATION | AN | Mar 20, 2009 |
6. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 3 different strengths of generic version for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.0103% BASE | solution | Discontinued | INHALATION | N/A | Mar 15, 2013 |
| EQ 0.021% BASE | solution | Discontinued | INHALATION | N/A | Mar 15, 2013 |
| EQ 0.042% BASE | solution | Discontinued | INHALATION | N/A | Mar 15, 2013 |
7. RITEDOSE CORP
The Ritedose Corp has filed for 3 different strengths of generic version for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Ritedose Corp.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.0103% BASE | solution | Prescription | INHALATION | AN | Mar 22, 2016 |
| EQ 0.021% BASE | solution | Prescription | INHALATION | AN | Mar 22, 2016 |
| EQ 0.042% BASE | solution | Prescription | INHALATION | AN | Mar 22, 2016 |
8. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.0103% BASE | solution | Discontinued | INHALATION | N/A | Nov 5, 2018 |
| EQ 0.021% BASE | solution | Discontinued | INHALATION | N/A | Nov 5, 2018 |
| EQ 0.042% BASE | solution | Discontinued | INHALATION | N/A | Nov 5, 2018 |
Manufacturing Plant Locations New
Sun Pharm'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 Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||||||||||||||||||||||
| India |
| |||||||||||||||||||||||||||||
9. TEVA PARENTERAL
Teva Parenteral Medicines Inc has filed for 1 generic for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Parenteral.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.25% BASE | solution | Prescription | INHALATION | AN | Sep 11, 2014 |
Manufacturing Plant Locations New
Teva Parenteral'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 Teva Parenteral as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
10. TEVA PHARMS USA
Teva Pharmaceuticals Usa has filed for 3 different strengths of generic version for Levalbuterol Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.021% BASE
(reference standard) | solution | Prescription | INHALATION | AN | Apr 26, 2013 |
| EQ 0.0103% BASE
(reference standard) | solution | Prescription | INHALATION | AN | Apr 26, 2013 |
| EQ 0.042% BASE
(reference standard) | solution | Prescription | INHALATION | AN | Apr 26, 2013 |