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Phenylephrine Hydrochloride Patent Expiration

Phenylephrine Hydrochloride was first introduced by Hikma Pharmaceuticals Usa Inc in its drug Phenylephrine Hydrochloride on Dec 20, 2012. Other drugs containing Phenylephrine Hydrochloride are Immphentiv, Vazculep, Biorphen. 22 different companies have introduced drugs containing Phenylephrine Hydrochloride.


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.

Given below is the list recent legal activities going on the following patents of Phenylephrine Hydrochloride.

Activity Date Patent Number
Patent litigations
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
Critical
 18 Jul, 2022 US8859623
Application Return TO OIPE 18 Jul, 2022 US8859623
Maintenance Fee Reminder Mailed
Critical
 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
Critical
 31 Aug, 2015 US8859623
Petition Requesting Trial 11 May, 2015 US8859623


Phenylephrine Hydrochloride's Family Patents

Family Patents

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Phenylephrine Hydrochloride Generic API Manufacturers

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 Somerset Therapeutics Llc and was approved on Feb 14, 2025.

Given below is the list of companies who have filed for Phenylephrine Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. 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
100MG/10ML (10MG/ML)

solution Discontinued INTRAVENOUS N/A Jul 1, 2020
10MG/ML (10MG/ML)

solution Discontinued INTRAVENOUS N/A Jul 1, 2020





2. 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
50MG/5ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jul 19, 2018
100MG/10ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jul 19, 2018


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
Brookhaven Amneal Pharmaceuticals of New York, LLC
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
Bridgewater Amneal Complex Products Research LLC
East Hanover Amneal Pharmaceuticals LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
India
Hyderabad Amneal Oncology Private Limited
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.





3. 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


Manufacturing Plant Locations
New

Aspiro'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 Aspiro as present at those locations.

Country City Firm Name
India
Siddipet (Dist) Aspiro Pharma Limited





4. 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





5. 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





6. 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
50MG/5ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jun 11, 2020
100MG/10ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jun 11, 2020
10MG/ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jun 11, 2020
10%

solution/drops Prescription OPHTHALMIC AT May 23, 2024
2.5%

solution/drops Prescription OPHTHALMIC AT May 23, 2024


Manufacturing Plant Locations
New

Caplin'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 Caplin as present at those locations.

Country City Firm Name
United States
Creve Coeur Caplin, Dr David
India
Gummidipoondi Caplin Steriles Limited





7. 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





8. 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


Manufacturing Plant Locations
New

Eugia 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 Eugia Pharma as present at those locations.

Country City Firm Name
India
Pashamylaram Eugia Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited





9. 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


Manufacturing Plant Locations
New

Fresenius Kabi Usa'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 Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Melrose Park Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Grand Island Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
North Andover Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Bensenville Fresenius Kabi USA LLC (FK USA)





10. GLAND

Gland 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 Gland.

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
2.5%

solution/drops Prescription OPHTHALMIC AT Dec 18, 2024
10%

solution/drops Prescription OPHTHALMIC AT Dec 18, 2024


Manufacturing Plant Locations
New

Gland'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 Gland as present at those locations.

Country City Firm Name
India
Hyderabad Gland Pharma Limited
Visakhapatnam Gland Pharma Limited
Parawada, Visakhapatnam Gland Pharma Limited
Aurangabad Gland Chemical Private Limited
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Sriperumbudur Gland Chemical Private Limited
Malur Gland Chemicals Pvt Ltd.





11. 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
100MG/10ML (10MG/ML)

solution Discontinued INTRAVENOUS N/A Mar 14, 2024
50MG/5ML (10MG/ML)

solution Discontinued INTRAVENOUS N/A Mar 14, 2024
10MG/ML (10MG/ML)

solution Discontinued INTRAVENOUS N/A Mar 14, 2024


Manufacturing Plant Locations
New

Hainan Poly's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Hainan Poly as present at those locations.

Country City Firm Name
China
Haikou Hainan Poly Pharm. Co., Ltd.





12. 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
50MG/5ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Aug 30, 2022
10MG/ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Aug 30, 2022
100MG/10ML (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


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
Paonta Sahib Mankind Pharma Limited
Imt Manesar Mankind Pharma Limited





13. 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





14. 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


Manufacturing Plant Locations
New

Provepharm Sas's manufacturing plants are situated in 1 country - France. Given below are the details of these plant locations as well as the firm names of Provepharm Sas as present at those locations.

Country City Firm Name
France
Marseille Provepharm Sas





15. 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





16. 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
100MG/10ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jan 31, 2019
50MG/5ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jan 31, 2019
10MG/ML (10MG/ML)

solution Prescription INTRAVENOUS AP1 Jan 31, 2019


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





17. SOMERSET THERAPS LLC

Somerset Therapeutics Llc has filed for 1 generic for Phenylephrine 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
0.5MG/5ML (0.1MG/ML)

solution Prescription INTRAVENOUS AP Feb 14, 2025