Nascobal is a drug owned by Endo Operations Ltd. It is protected by 6 US drug patents filed from 2013 to 2016 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 01, 2024. Details of Nascobal'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). | |||
| US7229636 | Cyanocobalamin low viscosity aqueous formulations for intranasal delivery |
Aug, 2024
(8 months ago) |
Expired
|
| US7879349 | Cyanocobalamin low viscosity aqueous formulations for intranasal delivery |
Aug, 2024
(8 months ago) |
Expired
|
| US8003353 | Cyanocobalamin low viscosity aqueous formulations for intranasal delivery |
Aug, 2024
(8 months ago) |
Expired
|
| US9415007 | Cyanocobalamin low viscosity aqueous formulations for intranasal delivery |
Jul, 2024
(8 months ago) |
Expired
|
| US7404489 | Cyanocobalamin low viscosity aqueous formulations for intranasal delivery |
Mar, 2024
(1 year, 1 month ago) |
Expired
|
| US8940714 | Cyanocobalamin low viscosity aqueous formulations for intranasal delivery |
Feb, 2024
(1 year, 1 month 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 Nascobal's patents.
Latest Legal Activities on Nascobal's Patents
Given below is the list of recent legal activities going on the following patents of Nascobal.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jan, 2024 | US9415007 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2023 | US8003353 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jul, 2022 | US7879349 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Jan, 2020 | US9415007 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Dec, 2019 | US7404489 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jan, 2019 | US8003353 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Nov, 2018 | US7229636 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jul, 2018 | US7879349 |
| Correspondence Address Change Critical | 23 Sep, 2016 | US7229636 |
| Correspondence Address Change Critical | 23 Sep, 2016 | US8003353 |
US patents provide insights into the exclusivity only within the United States, but Nascobal 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 Nascobal's family patents as well as insights into ongoing legal events on those patents.
Nascobal's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nascobal's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 01, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nascobal Generic API suppliers:
Cyanocobalamin is the generic name for the brand Nascobal. 32 different companies have already filed for the generic of Nascobal, with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nascobal's generic
How can I launch a generic of Nascobal before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nascobal's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nascobal'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 Nascobal -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mcg/spray | 28 Apr, 2017 | 1 | 01 Aug, 2024 | Extinguished |
About Nascobal
Nascobal is a drug owned by Endo Operations Ltd. It is used for treating vitamin B12 deficiencies through nasal administration of cyanocobalamin. Nascobal uses Cyanocobalamin as an active ingredient. Nascobal was launched by Endo Operations in 2005.
Approval Date:
Nascobal was approved by FDA for market use on 31 January, 2005.
Active Ingredient:
Nascobal uses Cyanocobalamin as the active ingredient. Check out other Drugs and Companies using Cyanocobalamin ingredient
Treatment:
Nascobal is used for treating vitamin B12 deficiencies through nasal administration of cyanocobalamin.
Dosage:
Nascobal is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5MG/SPRAY | SPRAY, METERED | Discontinued | NASAL |