Epoprostenol Sodium Patent Expiration

Epoprostenol Sodium was first introduced by Glaxosmithkline Llc in its drug Flolan on Sep 20, 1995. Another drug containing Epoprostenol Sodium is Veletri. 5 different companies have introduced drugs containing Epoprostenol Sodium.


Epoprostenol Sodium Patents

Given below is the list of patents protecting Epoprostenol Sodium, 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
Veletri US8318802 Epoprostenol formulation and method of making thereof Mar 15, 2027 Actelion
Veletri US8598227 Epoprostenol formulation and method of making thereof Feb 02, 2027 Actelion



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 Epoprostenol Sodium's patents.

Given below is the list recent legal activities going on the following patents of Epoprostenol Sodium.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 15 May, 2024 US8318802
Payment of Maintenance Fee, 8th Year, Large Entity 19 May, 2021 US8598227
Payment of Maintenance Fee, 8th Year, Large Entity 14 May, 2020 US8318802
Email Notification 05 Sep, 2014 US8598227
Change in Power of Attorney (May Include Associate POA) 05 Sep, 2014 US8598227
Filing Receipt - Replacement 05 Sep, 2014 US8598227
Electronic Review 23 Jul, 2014 US8598227
Email Notification 23 Jul, 2014 US8598227
Mail Pre-Exam Notice 23 Jul, 2014 US8598227
Change in Power of Attorney (May Include Associate POA) 22 Jul, 2014 US8318802


Epoprostenol Sodium's Family Patents

Family Patents

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Epoprostenol Sodium Generic API Manufacturers

Several generic applications have been filed for Epoprostenol Sodium. The first generic version for Epoprostenol Sodium was by Meitheal Pharmaceuticals Inc and was approved on Apr 23, 2008. And the latest generic version is by Mylan Pharmaceuticals Inc and was approved on Jun 12, 2024.

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


1. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 2 different strengths of generic version for Epoprostenol Sodium. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1.5MG BASE/VIAL

injectable Prescription INJECTION AP1 Apr 23, 2008
EQ 0.5MG BASE/VIAL

injectable Prescription INJECTION AP1 Apr 23, 2008





2. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Epoprostenol Sodium. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1.5MG BASE/VIAL

injectable Prescription INJECTION AP2 Jun 12, 2024
EQ 0.5MG BASE/VIAL

injectable Prescription INJECTION AP2 Jun 12, 2024


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos Mylan Pharmaceuticals Inc.
Saint Albans Mylan Technologies, Inc.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Rockford Mylan Institutional, Inc.
India
Anekal Taluk, Bangalore Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Pithampur, District Dhar Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





3. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Epoprostenol Sodium. 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 0.5MG BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP2 Jan 15, 2021
EQ 1.5MG BASE/VIAL

injectable Prescription INJECTION AP2 Jan 15, 2021


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
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Dadra Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Vadodara Sun Pharmaceutical Industries Ltd.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Vadodara Sun Pharmaceutical Industries Ltd
Bharuch Sun Pharmaceutical Industries Ltd
Baruch Sun Pharmaceutical Industries Ltd.
Halol Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)