Phenylephrine Hydrochloride Patent Expiration
Phenylephrine Hydrochloride was first introduced by Hikma Pharmaceuticals Usa Inc
Phenylephrine Hydrochloride Patents
Given below is the list of patents protecting Phenylephrine 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 |
|---|---|---|---|---|
| Immphentiv | US11213480 | Phenylephrine hydrochloride ready-to-use solution | Sep 26, 2036 | Hikma |
| Immphentiv | US11471400 | Phenylephrine hydrochloride ready-to-use solution | Aug 05, 2036 | Hikma |
| Phenylephrine Hydrochloride | US8859623 | Methods and compositions of stable phenylephrine formulations | Nov 14, 2033 | Paragon Bioteck |
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 Phenylephrine Hydrochloride's patents.
Latest Legal Activities on Phenylephrine Hydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Phenylephrine Hydrochloride.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 7.5 yr surcharge - late pmt w/in 6 mo, Large Entity | 03 Oct, 2022 | US8859623 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Oct, 2022 | US8859623 |
| Application Return from OIPE | 18 Jul, 2022 | US8859623 |
| Correspondence Address Change | 18 Jul, 2022 | US8859623 |
| Application Return TO OIPE | 18 Jul, 2022 | US8859623 |
| Maintenance Fee Reminder Mailed | 06 Jun, 2022 | US8859623 |
| Appeal to Court of Appeals | 13 Jan, 2017 | US8859623 |
| Termination or Final Written Decision | 14 Nov, 2016 | US8859623 |
| Application ready for PDX access by participating foreign offices | 31 Aug, 2015 | US8859623 |
| Petition Requesting Trial | 11 May, 2015 | US8859623 |
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Phenylephrine Hydrochloride Generics
Several generic applications have been filed for Phenylephrine Hydrochloride. The first generic version for Phenylephrine Hydrochloride was by Meitheal Pharmaceuticals Inc and was approved on Apr 27, 2018. And the latest generic version is by Caplin Steriles Ltd and was approved on May 23, 2024.
Given below is the list of companies who have filed for Phenylephrine Hydrochloride generic.
1. PROVEPHARM SAS
Provepharm Sas has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Provepharm Sas.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jul 17, 2020 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jul 17, 2020 |
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jul 17, 2020 |
2. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/5ML (10MG/ML) | solution | Discontinued | INTRAVENOUS | N/A | Jul 1, 2020 |
| 10MG/ML (10MG/ML) | solution | Discontinued | INTRAVENOUS | N/A | Jul 1, 2020 |
| 100MG/10ML (10MG/ML) | solution | Discontinued | INTRAVENOUS | N/A | Jul 1, 2020 |
3. AMNEAL
Amneal Eu Ltd has filed for 3 different strengths of generic version for Phenylephrine 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 |
|---|---|---|---|---|---|
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jul 5, 2018 |
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jul 19, 2018 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jul 19, 2018 |
4. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jun 5, 2020 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jun 5, 2020 |
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Apr 8, 2021 |
5. ASPIRO
Aspiro Pharma Ltd has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Aspiro.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | May 10, 2024 |
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | May 10, 2024 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | May 10, 2024 |
6. SANDOZ
Sandoz Inc has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jan 31, 2019 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jan 31, 2019 |
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jan 31, 2019 |
7. CAPLIN
Caplin Steriles Ltd has filed for 5 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Caplin.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jun 11, 2020 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jun 11, 2020 |
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jun 11, 2020 |
| 2.5% | solution/drops | Prescription | OPHTHALMIC | AT | May 23, 2024 |
| 10% | solution/drops | Prescription | OPHTHALMIC | AT | May 23, 2024 |
8. BE PHARMS
Be Pharmaceuticals Ag has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Be Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP2 | Jun 26, 2023 |
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP2 | Jun 26, 2023 |
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP2 | Jun 26, 2023 |
9. AVET LIFESCIENCES
Avet Lifesciences Private Ltd has filed for 1 generic for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Avet Lifesciences.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP2 | Feb 28, 2023 |
10. MEITHEAL
Meitheal Pharmaceuticals Inc has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Meitheal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Apr 27, 2018 |
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP2 | Apr 27, 2018 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Apr 27, 2018 |
11. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Nov 13, 2020 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Nov 13, 2020 |
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP2 | Jan 7, 2021 |
12. ENDO OPERATIONS
Endo Operations Ltd has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Endo Operations.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Dec 21, 2018 |
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Dec 21, 2018 |
| 10MG/ML (10MG/ML) | solution | Discontinued | INTRAVENOUS | N/A | Dec 21, 2018 |
13. HAINAN POLY
Hainan Poly Pharm Co Ltd has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hainan Poly.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Mar 14, 2024 |
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Mar 14, 2024 |
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Mar 14, 2024 |
14. MANKIND PHARMA
Mankind Pharma Ltd has filed for 5 different strengths of generic version for Phenylephrine 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 |
|---|---|---|---|---|---|
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Aug 30, 2022 |
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Aug 30, 2022 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Aug 30, 2022 |
| 2.5%
(reference standard) | solution/drops | Prescription | OPHTHALMIC | AT | Sep 29, 2022 |
| 10%
(reference standard) | solution/drops | Prescription | OPHTHALMIC | AT | Jan 11, 2023 |
15. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP2 | Jan 29, 2019 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jan 30, 2019 |
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jan 30, 2019 |
16. SAGENT PHARMS INC
Sagent Pharmaceuticals Inc has filed for 3 different strengths of generic version for Phenylephrine Hydrochloride. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/10ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jan 16, 2020 |
| 50MG/5ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jan 16, 2020 |
| 10MG/ML (10MG/ML) | solution | Prescription | INTRAVENOUS | AP1 | Jan 16, 2020 |