Milnacipran Hydrochloride Patent Expiration

Milnacipran Hydrochloride is Used for managing fibromyalgia. It was first introduced by Abbvie Inc in its drug Savella on Jan 14, 2009. 4 different companies have introduced drugs containing Milnacipran Hydrochloride.


Milnacipran Hydrochloride Patents

Given below is the list of patents protecting Milnacipran 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
Savella US7994220 Milnacipran for the long-term treatment of fibromyalgia syndrome Sep 19, 2029 Abbvie
Savella US6602911 Methods of treating fibromyalgia Jan 14, 2023

(Expired)

Abbvie
Savella US6992110 Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain Nov 05, 2021

(Expired)

Abbvie
Savella US7888342 Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain Nov 05, 2021

(Expired)

Abbvie



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 Milnacipran Hydrochloride's patents.

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

Activity Date Patent Number
Patent litigations
Expire Patent 20 Mar, 2023 US7888342
Payment of Maintenance Fee, 12th Year, Large Entity 11 Jan, 2023 US7994220
Maintenance Fee Reminder Mailed 03 Oct, 2022 US7888342
Payment of Maintenance Fee, 8th Year, Large Entity 11 Feb, 2019 US7994220
Payment of Maintenance Fee, 8th Year, Large Entity 21 Aug, 2018 US7888342
Patent Term Extension Certificate 24 Aug, 2012 US6602911
Notice of Final Determination -Election Required 23 Apr, 2012 US6602911
Notice of Final Determination -Election Required 23 Apr, 2012 US6992110
Patent Issue Date Used in PTA Calculation 09 Aug, 2011 US7994220
Recordation of Patent Grant Mailed 09 Aug, 2011 US7994220


Milnacipran Hydrochloride's Family Patents

Family Patents

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Milnacipran Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Milnacipran Hydrochloride. The first generic version for Milnacipran Hydrochloride was by Oryza Pharmaceuticals Inc and was approved on Jan 27, 2016. And the latest generic version is by Hetero Labs Ltd Unit V and was approved on Oct 3, 2024.

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


1. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 4 different strengths of generic version for Milnacipran Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
12.5MG

tablet Discontinued ORAL N/A Apr 22, 2016
25MG

tablet Discontinued ORAL N/A Apr 22, 2016
50MG

tablet Discontinued ORAL N/A Apr 22, 2016
100MG

tablet Discontinued ORAL N/A Apr 22, 2016





2. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 4 different strengths of generic version for Milnacipran Hydrochloride. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
12.5MG

tablet Prescription ORAL AB Oct 3, 2024
25MG

tablet Prescription ORAL AB Oct 3, 2024
50MG

tablet Prescription ORAL AB Oct 3, 2024
100MG

tablet Prescription ORAL AB Oct 3, 2024





3. ORYZA

Oryza Pharmaceuticals Inc has filed for 4 different strengths of generic version for Milnacipran Hydrochloride. Given below are the details of the strengths of this generic introduced by Oryza.

Strength Dosage Form Availability Application Pathway TE code Launch Date
12.5MG

tablet Discontinued ORAL N/A Jan 27, 2016
25MG

tablet Discontinued ORAL N/A Jan 27, 2016
50MG

tablet Discontinued ORAL N/A Jan 27, 2016
100MG

tablet Discontinued ORAL N/A Jan 27, 2016


Manufacturing Plant Locations
New

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

Country City Firm Name
Japan
Ichinomiya Oryza Oil & Fat Chemical Co., Ltd.