Ramelteon Patent Expiration
Ramelteon is used for treating insomnia. It was first introduced by Takeda Pharmaceuticals Usa Inc
Ramelteon Patents
Given below is the list of patents protecting Ramelteon, 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 |
|---|---|---|---|---|
| Rozerem | US10098866 | Pharmaceutical preparation containing copolyvidone |
Nov 16, 2021
(Expired) | Takeda Pharms Usa |
| Rozerem | US6034239 | Tricyclic compounds, their production and use |
Jul 22, 2019
(Expired) | Takeda Pharms Usa |
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 Ramelteon's patents.
Latest Legal Activities on Ramelteon's Patents
Given below is the list recent legal activities going on the following patents of Ramelteon.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 21 Nov, 2022 | US10098866 |
| Maintenance Fee Reminder Mailed Critical | 06 Jun, 2022 | US10098866 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Oct, 2018 | US10098866 |
| Recordation of Patent Grant Mailed Critical | 16 Oct, 2018 | US10098866 |
| Email Notification Critical | 27 Sep, 2018 | US10098866 |
| Issue Notification Mailed Critical | 26 Sep, 2018 | US10098866 |
| Dispatch to FDC | 17 Sep, 2018 | US10098866 |
| Application Is Considered Ready for Issue Critical | 15 Sep, 2018 | US10098866 |
| Issue Fee Payment Received Critical | 11 Sep, 2018 | US10098866 |
| Issue Fee Payment Verified Critical | 11 Sep, 2018 | US10098866 |
Ramelteon's Family Patents
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Ramelteon Generic API Manufacturers
Several generic applications have been filed for Ramelteon. The first generic version for Ramelteon was by Dr Reddys Laboratories Sa and was approved on Jul 26, 2013. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Jul 10, 2023.
Given below is the list of companies who have filed for Ramelteon generic, along with the locations of their manufacturing plants worldwide.
1. ACTAVIS LABS FL INC
Actavis Laboratories Fl Inc has filed for 1 generic for Ramelteon. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Aug 19, 2015 |
2. ANDAS 5 HOLDING
Andas 5 Holding Llc has filed for 1 generic for Ramelteon. Given below are the details of the strengths of this generic introduced by Andas 5 Holding.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Aug 24, 2022 |
3. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 1 generic for Ramelteon. 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 |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Jul 10, 2023 |
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 |
| |||
4. DR REDDYS LABS SA
Dr Reddys Laboratories Sa has filed for 1 generic for Ramelteon. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Jul 26, 2013 |
5. GRANULES
Granules Pharmaceuticals Inc has filed for 1 generic for Ramelteon. Given below are the details of the strengths of this generic introduced by Granules.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Aug 21, 2020 |
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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||||
| India |
| |||||||||||
6. I3 PHARMS
I3 Pharmaceuticals Llc has filed for 1 generic for Ramelteon. Given below are the details of the strengths of this generic introduced by I3 Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Apr 10, 2020 |
7. MICRO LABS
Micro Labs Ltd has filed for 1 generic for Ramelteon. 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 |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Feb 9, 2023 |
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 |
| |||||||||
8. UPSHER SMITH LABS
Upsher Smith Laboratories Llc has filed for 1 generic for Ramelteon. Given below are the details of the strengths of this generic introduced by Upsher Smith Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Oct 26, 2020 |
9. XIROMED
Xiromed Pharma Espana Sl has filed for 1 generic for Ramelteon. Given below are the details of the strengths of this generic introduced by Xiromed.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Nov 25, 2022 |
Manufacturing Plant Locations New
Xiromed'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 Xiromed as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
10. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Ramelteon. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 8MG | tablet | Prescription | ORAL | AB | Jul 22, 2019 |