Carnexiv is a drug owned by Lundbeck Pharmaceuticals Llc. It is protected by 7 US drug patents filed from 2016 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 31, 2040. Details of Carnexiv'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). | |||
| US11529357 | Injectable carbamazepine composition essentially free of 10-bromo-carbamazepine |
Jan, 2040
(15 years from now) | Active |
| US9493582 | Alkylated cyclodextrin compositions and processes for preparing and using the same |
Feb, 2033
(8 years from now) | Active |
| US9750822 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(4 years from now) | Active |
| US7635773 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(4 years from now) | Active |
| US8410077 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(4 years from now) | Active |
| US9629797 | Parenteral carbamazepine formulation |
Nov, 2028
(3 years from now) | Active |
| US9770407 | Parenteral carbamazepine formulation |
Nov, 2028
(3 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 Carnexiv's patents.
Latest Legal Activities on Carnexiv's Patents
Given below is the list of recent legal activities going on the following patents of Carnexiv.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2024 | US9493582 |
| Post Issue Communication - Certificate of Correction | 08 Feb, 2023 | US11529357 |
| Recordation of Patent Grant Mailed Critical | 20 Dec, 2022 | US11529357 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Dec, 2022 | US11529357 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US8410077 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US7635773 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US9493582 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US9750822 |
| Email Notification Critical | 01 Dec, 2022 | US11529357 |
| Issue Notification Mailed Critical | 30 Nov, 2022 | US11529357 |
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 Carnexiv and ongoing litigations to help you estimate the early arrival of Carnexiv generic.
Carnexiv's Litigations
Carnexiv been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 03, 2014, against patent number US9629797. The petitioner , challenged the validity of this patent, with James Cloyd et al as the respondent. Click below to track the latest information on how companies are challenging Carnexiv's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9770407 | December, 2014 |
Decision
(15 Mar, 2017) | Lundbeck Pharmaceuticals LLC | |
| US9629797 | July, 2014 |
Decision
(15 Dec, 2016) | James Cloyd et al | |
FDA has granted some exclusivities to Carnexiv. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Carnexiv, 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 Carnexiv.
Exclusivity Information
Carnexiv holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Carnexiv's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Oct 07, 2023 |
| Orphan Drug Exclusivity(ODE-124) | Oct 07, 2023 |
Several oppositions have been filed on Carnexiv'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 Carnexiv's generic, the next section provides detailed information on ongoing and past EP oppositions related to Carnexiv patents.
Carnexiv's Oppositions Filed in EPO
Carnexiv has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 06, 2015, by Actavis Group Ptc Ehf. This opposition was filed on patent number EP06816054A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP06816054A | Feb, 2015 | Actavis Group PTC ehf | Revoked |
US patents provide insights into the exclusivity only within the United States, but Carnexiv 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 Carnexiv's family patents as well as insights into ongoing legal events on those patents.
Carnexiv's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Carnexiv's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 31, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Carnexiv Generic API suppliers:
Carbamazepine is the generic name for the brand Carnexiv. 30 different companies have already filed for the generic of Carnexiv, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Carnexiv's generic
Alternative Brands for Carnexiv
Carnexiv which is used for treating mixed seizure patterns in adults., has several other brand drugs using the same active ingredient (Carbamazepine). 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 brand drugs containing the same ingredient, some generics have also been filed for Carbamazepine, Carnexiv's active ingredient. Check the complete list of approved generic manufacturers for Carnexiv
About Carnexiv
Carnexiv is a drug owned by Lundbeck Pharmaceuticals Llc. It is used for treating mixed seizure patterns in adults. Carnexiv uses Carbamazepine as an active ingredient. Carnexiv was launched by Lundbeck Pharms Llc in 2016.
Approval Date:
Carnexiv was approved by FDA for market use on 07 October, 2016.
Active Ingredient:
Carnexiv uses Carbamazepine as the active ingredient. Check out other Drugs and Companies using Carbamazepine ingredient
Treatment:
Carnexiv is used for treating mixed seizure patterns in adults.
Dosage:
Carnexiv is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG/20ML (10MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |