Cubicin is a drug owned by Cubist Pharmaceuticals Llc. It is protected by 7 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 23, 2030. Details of Cubicin'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| USRE39071 | Anhydro-and isomer-a-21978c cyclic peptides |
Jun, 2016
(8 years ago) |
Expired
|
| US6468967 | Methods for administration of antibiotics |
Sep, 2019
(4 years ago) |
Expired
|
| US6852689 | Methods for administration of antibiotics |
Sep, 2019
(4 years ago) |
Expired
|
| US8058238 | High purity lipopeptides |
Nov, 2020
(3 years ago) |
Expired
|
| US8129342 | High purity lipopeptides |
Nov, 2020
(3 years ago) |
Expired
|
| US8003673 | Daptomycin for the treatment of biofilm and catheter salvage |
Sep, 2028
(4 years from now) | Active |
| US9138456 | Lipopeptide compositions and related methods |
Nov, 2030
(6 years from now) | Active |
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 Cubicin's patents.
Latest Legal Activities on Cubicin's Patents
Given below is the list of recent legal activities going on the following patents of Cubicin.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 08 Apr, 2024 | US8129342 (Litigated) |
| Expire Patent | 18 Dec, 2023 | US8058238 (Litigated) |
| Maintenance Fee Reminder Mailed | 23 Oct, 2023 | US8129342 (Litigated) |
| Maintenance Fee Reminder Mailed | 03 Jul, 2023 | US8058238 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Feb, 2023 | US9138456 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2023 | US8003673 |
| Request for Trial Denied | 29 May, 2020 | US9138456 |
| Petition Requesting Trial | 27 Nov, 2019 | US9138456 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Aug, 2019 | US8129342 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Apr, 2019 | US8058238 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Cubicin and ongoing litigations to help you estimate the early arrival of Cubicin generic.
Cubicin's Litigations
Cubicin has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 27, 2019, against patent number US9138456. The petitioner Amneal Pharmaceuticals LLC, challenged the validity or infringement of this patent, with Cubist Pharmaceuticals LLC as the respondent. Click below to track the latest information on how companies are challenging Cubicin's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9138456 | November, 2019 | Terminated-Denied | Cubist Pharmaceuticals LLC | Amneal Pharmaceuticals LLC |
FDA has granted some exclusivities to Cubicin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cubicin, 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 Cubicin.
Exclusivity Information
Cubicin holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Cubicin's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Mar 29, 2020 |
| M(M-211) | Sep 01, 2020 |
Several oppositions have been filed on Cubicin's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Cubicin's generic, the next section provides detailed information on ongoing and past EP oppositions related to Cubicin patents.
Cubicin's oppositions filed in EPO
Cubicin has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 10, 2019, by Hgf Limited. This opposition was filed on patent number EP10832379A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP10832379A | Apr, 2019 | Pajaro Limited | Granted and Under Opposition |
| EP10832379A | Apr, 2019 | HGF Limited | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Cubicin 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 Cubicin's family patents as well as insights into ongoing legal events on those patents.
Cubicin's family patents
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Generic Launch
Generic Release Date:
Cubicin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 23, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cubicin Generics:
Daptomycin is the generic name for the brand Cubicin. 18 different companies have already filed for the generic of Cubicin, with Dr Reddys having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cubicin's generic
How can I launch a generic of Cubicin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cubicin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cubicin'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 Cubicin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/vial | 19 Nov, 2008 | 1 | Extinguished |
About Cubicin
Cubicin is a drug owned by Cubist Pharmaceuticals Llc. It is used for treating bacterial infections, including skin infections and bloodstream infections. Cubicin uses Daptomycin as an active ingredient. Cubicin was launched by Cubist Pharms Llc in 2003.
Market Authorisation Date:
Cubicin was approved by FDA for market use on 12 September, 2003.
Active Ingredient:
Cubicin uses Daptomycin as the active ingredient. Check out other Drugs and Companies using Daptomycin ingredient
Treatment:
Cubicin is used for treating bacterial infections, including skin infections and bloodstream infections.
Dosage:
Cubicin is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER | Discontinued | INTRAVENOUS |
| 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER | Discontinued | INTRAVENOUS |