Cymbalta is a drug owned by Eli Lilly And Co. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 20, 2023. Details of Cymbalta'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). | |||
|
US6596756 (Pediatric) | Treatment of fibromyalgia |
Mar, 2020
(4 years ago) |
Expired
|
| US6596756 | Treatment of fibromyalgia |
Sep, 2019
(5 years ago) |
Expired
|
|
US5508276 (Pediatric) | Duloxetine enteric pellets |
Jan, 2015
(9 years ago) |
Expired
|
| US5508276 | Duloxetine enteric pellets |
Jul, 2014
(10 years ago) |
Expired
|
|
US5023269 (Pediatric) | 3-aryloxy-3-substituted propanamines |
Dec, 2013
(11 years ago) |
Expired
|
| US5023269 | 3-aryloxy-3-substituted propanamines |
Jun, 2013
(11 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 Cymbalta's patents.
Latest Legal Activities on Cymbalta's Patents
Given below is the list of recent legal activities going on the following patents of Cymbalta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 22 Jul, 2003 | US6596756 |
| Patent Issue Date Used in PTA Calculation Critical | 22 Jul, 2003 | US6596756 |
| Issue Notification Mailed Critical | 02 Jul, 2003 | US6596756 |
| Receipt into Pubs | 19 Jun, 2003 | US6596756 |
| Application Is Considered Ready for Issue Critical | 18 Jun, 2003 | US6596756 |
| Issue Fee Payment Received Critical | 09 Jun, 2003 | US6596756 |
| Issue Fee Payment Verified Critical | 09 Jun, 2003 | US6596756 |
| Receipt into Pubs | 22 May, 2003 | US6596756 |
| Workflow - File Sent to Contractor | 11 Apr, 2003 | US6596756 |
| Receipt into Pubs | 04 Apr, 2003 | US6596756 |
FDA has granted several exclusivities to Cymbalta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cymbalta, 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 Cymbalta.
Exclusivity Information
Cymbalta holds 5 exclusivities. All of its exclusivities have expired in 2023. Details of Cymbalta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-617) | Nov 19, 2012 |
| New Indication(I-632) | Nov 04, 2013 |
| Pediatric Exclusivity(PED) | Apr 18, 2016 |
| M(M-61) | Oct 18, 2015 |
| New Patient Population(NPP) | Apr 20, 2023 |
US patents provide insights into the exclusivity only within the United States, but Cymbalta 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 Cymbalta's family patents as well as insights into ongoing legal events on those patents.
Cymbalta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cymbalta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 20, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cymbalta Generic API suppliers:
Duloxetine Hydrochloride is the generic name for the brand Cymbalta. 23 different companies have already filed for the generic of Cymbalta, with Breckenridge having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cymbalta's generic
How can I launch a generic of Cymbalta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cymbalta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cymbalta'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 Cymbalta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg, 30 mg and 60 mg | 04 Aug, 2008 | 16 | 11 Dec, 2013 | 18 Jul, 2014 | Eligible |
| 40 mg | 10 May, 2012 | 1 | 11 Dec, 2013 | 18 Jul, 2014 | Eligible |
Alternative Brands for Cymbalta
Cymbalta which is used for managing fibromyalgia, treating anxiety, and major depressive disorder by potentiating serotonergic and noradrenergic activity in the CNS., has several other brand drugs in the same treatment category and using the same active ingredient (Duloxetine 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.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Abbvie |
| |||
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. Duloxetine Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Sun Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Duloxetine Hydrochloride, Cymbalta's active ingredient. Check the complete list of approved generic manufacturers for Cymbalta
About Cymbalta
Cymbalta is a drug owned by Eli Lilly And Co. It is used for managing fibromyalgia, treating anxiety, and major depressive disorder by potentiating serotonergic and noradrenergic activity in the CNS. Cymbalta uses Duloxetine Hydrochloride as an active ingredient. Cymbalta was launched by Lilly in 2004.
Approval Date:
Cymbalta was approved by FDA for market use on 03 August, 2004.
Active Ingredient:
Cymbalta uses Duloxetine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Duloxetine Hydrochloride ingredient
Treatment:
Cymbalta is used for managing fibromyalgia, treating anxiety, and major depressive disorder by potentiating serotonergic and noradrenergic activity in the CNS.
Dosage:
Cymbalta is available in capsule, delayed rel pellets form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS | Prescription | ORAL |
| EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS | Prescription | ORAL |
| EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS | Prescription | ORAL |