Levocetirizine Dihydrochloride Patent Expiration
Levocetirizine Dihydrochloride was first introduced by Chattem Inc Dba Sanofi Consumer Healthcare
Levocetirizine Dihydrochloride Patents
Given below is the list of patents protecting Levocetirizine Dihydrochloride, 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 |
|---|---|---|---|---|
| Xyzal Allergy 24hr | US8633194 | Pharmaceutical composition of piperazine derivatives | Oct 16, 2027 | Chattem Sanofi |
| Xyzal |
US5698558 (Pediatric) | Methods for treating allergic disorders using optically pure (-) cetirizine |
Jan 26, 2014
(Expired) | Chattem Sanofi |
| Xyzal | US5698558 | Methods for treating allergic disorders using optically pure (-) cetirizine |
Jul 26, 2013
(Expired) | Chattem Sanofi |
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 Levocetirizine Dihydrochloride's patents.
Latest Legal Activities on Levocetirizine Dihydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Levocetirizine Dihydrochloride.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Review Certificate Mailed | 16 Aug, 2021 | US8633194 |
| Review Certificate | 22 Jul, 2021 | US8633194 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Jul, 2021 | US8633194 |
| Termination or Final Written Decision | 09 Jun, 2020 | US8633194 |
| Request for Trial Granted Critical | 15 Jul, 2019 | US8633194 |
| Petition Requesting Trial | 13 Dec, 2018 | US8633194 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Jan, 2014 | US8633194 |
| Recordation of Patent Grant Mailed Critical | 21 Jan, 2014 | US8633194 |
| Issue Notification Mailed Critical | 31 Dec, 2013 | US8633194 |
| Dispatch to FDC | 20 Dec, 2013 | US8633194 |
Levocetirizine Dihydrochloride's Family Patents
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Levocetirizine Dihydrochloride Generic API Manufacturers
Several generic applications have been filed for Levocetirizine Dihydrochloride. The first generic version for Levocetirizine Dihydrochloride was by Synthon Pharmaceuticals Inc and was approved on Nov 26, 2010. And the latest generic version is by Ipca Laboratories Ltd and was approved on May 6, 2024.
Given below is the list of companies who have filed for Levocetirizine Dihydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. APOTEX
Apotex Inc has filed for 2 different strengths of generic version for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG/5ML | solution | Discontinued | ORAL | N/A | Aug 21, 2014 |
| 5MG | tablet | Over the counter | ORAL | N/A | Apr 21, 2021 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
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| United States |
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| Canada |
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| India |
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2. CHARTWELL MOLECULAR
Chartwell Molecular Holdings Llc has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Molecular.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG/5ML | solution | Prescription | ORAL | AA | May 15, 2017 |
3. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Over the counter | ORAL | N/A | Jan 19, 2018 |
4. DR REDDYS LABS LTD
Dr Reddys Laboratories Limited has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Feb 24, 2011 |
5. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG
(reference standard) | tablet | Prescription | ORAL | AB | Feb 24, 2011 |
6. GRANULES
Granules India Ltd has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Granules.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | Mar 26, 2013 |
Manufacturing Plant Locations New
Granules'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 Granules as present at those locations.
| Country | City | Firm Name | ||||||||||
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| United States |
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| India |
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7. HETERO LABS LTD III
Hetero Labs Ltd Unit Iii has filed for 2 different strengths of generic version for Levocetirizine Dihydrochloride. Out of these 2.5mg/5ml version comes by the name LEVOCETIRIZINE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Over the counter | ORAL | N/A | Apr 29, 2020 |
| 2.5MG/5ML | solution | Prescription | ORAL | AA | Apr 1, 2019 |
8. IPCA LABS LTD
Ipca Laboratories Ltd has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Ipca Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | May 6, 2024 |
9. MACLEODS PHARMS LTD
Macleods Pharmaceuticals Ltd has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Jan 11, 2016 |
10. MICRO LABS
Micro Labs Ltd has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Micro Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Over the counter | ORAL | N/A | Nov 20, 2018 |
Manufacturing Plant Locations New
Micro Labs'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 Micro Labs as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
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11. MICRO LABS LTD INDIA
Micro Labs Ltd India has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Micro Labs Ltd India.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Sep 17, 2013 |
12. PADAGIS US
Padagis Us Llc has filed for 1 generic for Levocetirizine Dihydrochloride. 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 |
|---|---|---|---|---|---|
| 2.5MG/5ML
(reference standard) | solution | Prescription | ORAL | AA | Nov 7, 2011 |
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 |
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13. PERRIGO R AND D
Perrigo R And D Co has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Perrigo R And D.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Over the counter | ORAL | N/A | Mar 28, 2019 |
14. SCIEGEN PHARMS INC
Sciegen Pharmaceuticals Inc has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Sep 9, 2014 |
15. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Levocetirizine Dihydrochloride. 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 |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Jan 31, 2013 |
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.
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| United States |
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16. SUN PHARM INDS LTD
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | Jun 26, 2015 |
17. SYNTHON PHARMS
Synthon Pharmaceuticals Inc has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Synthon Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Nov 26, 2010 |
18. TARO
Taro Pharmaceutical Industries Ltd has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Taro.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG/5ML | solution | Prescription | ORAL | AA | Jul 26, 2013 |
Manufacturing Plant Locations New
Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.
| Country | City | Firm Name | ||||
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| United States |
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| Israel |
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| Canada |
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19. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Aug 22, 2011 |
20. US ANTIBIOTICS
Us Antibiotics Llc has filed for 1 generic for Levocetirizine Dihydrochloride. Given below are the details of the strengths of this generic introduced by Us Antibiotics.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | Dec 20, 2016 |