Savella is a drug owned by Abbvie Inc. It is protected by 4 US drug patents filed in 2013. Out of these, 1 drug patents are active and 3 have expired. Savella's patents have been open to challenges since 14 January, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 19, 2029. Details of Savella's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7994220 | Milnacipran for the long-term treatment of fibromyalgia syndrome |
Sep, 2029
(4 years from now) | Active |
| US6602911 | Methods of treating fibromyalgia |
Jan, 2023
(1 year, 11 months ago) |
Expired
|
| US7888342 | Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain |
Nov, 2021
(3 years ago) |
Expired
|
| US6992110 | Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain |
Nov, 2021
(3 years ago) |
Expired
|
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 Savella's patents.
Latest Legal Activities on Savella's Patents
Given below is the list of recent legal activities going on the following patents of Savella.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 20 Mar, 2023 | US7888342 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2023 | US7994220 |
| Maintenance Fee Reminder Mailed Critical | 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 Critical | 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 Critical | 09 Aug, 2011 | US7994220 |
| Recordation of Patent Grant Mailed Critical | 09 Aug, 2011 | US7994220 |
FDA has granted several exclusivities to Savella. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Savella, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Savella.
Exclusivity Information
Savella holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Savella's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 14, 2014 |
US patents provide insights into the exclusivity only within the United States, but Savella is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Savella's family patents as well as insights into ongoing legal events on those patents.
Savella's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Savella's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 19, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Savella Generic API suppliers:
Milnacipran Hydrochloride is the generic name for the brand Savella. 3 different companies have already filed for the generic of Savella, with Amneal Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Savella's generic
How can I launch a generic of Savella before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Savella's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Savella's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Savella -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12.5 mg, 25 mg, 50 mg, and 100 mg | 14 Jan, 2013 | 8 | 27 Jan, 2016 | 19 Sep, 2029 | Deferred |
Alternative Brands for Savella
Savella which is used for managing fibromyalgia., has several other brand drugs in the same treatment category and using the same active ingredient (Milnacipran Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Milnacipran Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Milnacipran Hydrochloride, Savella's active ingredient. Check the complete list of approved generic manufacturers for Savella
About Savella
Savella is a drug owned by Abbvie Inc. It is used for managing fibromyalgia. Savella uses Milnacipran Hydrochloride as an active ingredient. Savella was launched by Abbvie in 2009.
Can you believe Savella received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Savella was approved by FDA for market use on 14 January, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Savella is 14 January, 2009, its NCE-1 date is estimated to be 14 January, 2013.
Active Ingredient:
Savella uses Milnacipran Hydrochloride as the active ingredient. Check out other Drugs and Companies using Milnacipran Hydrochloride ingredient
Treatment:
Savella is used for managing fibromyalgia.
Dosage:
Savella is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5MG | TABLET | Prescription | ORAL |
| 25MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |