Balcoltra is a drug owned by Avion Pharmaceuticals Llc. It is protected by 2 US drug patents filed from 2018 to 2021. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 01, 2027. Details of Balcoltra's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7838042 | Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions |
Jun, 2027
(2 years from now) | Active |
| US6716814 | Enhancing solubility of iron amino acid chelates and iron proteinates |
Aug, 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 Balcoltra's patents.
Latest Legal Activities on Balcoltra's Patents
Given below is the list of recent legal activities going on the following patents of Balcoltra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 May, 2022 | US7838042 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Apr, 2018 | US7838042 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 07 Sep, 2017 | US7838042 |
| Recordation of Patent Grant Mailed Critical | 23 Nov, 2010 | US7838042 |
| Patent Issue Date Used in PTA Calculation Critical | 23 Nov, 2010 | US7838042 |
| Email Notification Critical | 04 Nov, 2010 | US7838042 |
| Issue Notification Mailed Critical | 03 Nov, 2010 | US7838042 |
| Application Is Considered Ready for Issue Critical | 21 Oct, 2010 | US7838042 |
| Dispatch to FDC | 21 Oct, 2010 | US7838042 |
| Issue Fee Payment Received Critical | 20 Oct, 2010 | US7838042 |
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 Balcoltra and ongoing litigations to help you estimate the early arrival of Balcoltra generic.
Balcoltra's Litigations
Balcoltra been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 23, 2008, against patent number US7838042. The petitioner , challenged the validity of this patent, with Max R. Motyka et al as the respondent. Click below to track the latest information on how companies are challenging Balcoltra's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7838042 | December, 2008 |
Decision
(06 Apr, 2010) | Max R. Motyka et al | |
US patents provide insights into the exclusivity only within the United States, but Balcoltra 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 Balcoltra's family patents as well as insights into ongoing legal events on those patents.
Balcoltra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Balcoltra's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 01, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Balcoltra Generic API suppliers:
Ethinyl Estradiol; Levonorgestrel is the generic name for the brand Balcoltra. 16 different companies have already filed for the generic of Balcoltra, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Balcoltra's generic
How can I launch a generic of Balcoltra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Balcoltra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Balcoltra'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 Balcoltra -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.1 mg/0.02 mg | 14 Jul, 2020 | 1 | 16 Aug, 2021 | Extinguished |
Alternative Brands for Balcoltra
Balcoltra which is used for treating iron deficiency., has several other brand drugs using the same active ingredient (Ethinyl Estradiol; Levonorgestrel). 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 | |||||
|---|---|---|---|---|---|---|
| Agile |
| |||||
| Teva Branded Pharm |
| |||||
| Wyeth Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ethinyl Estradiol; Levonorgestrel, Balcoltra's active ingredient. Check the complete list of approved generic manufacturers for Balcoltra
About Balcoltra
Balcoltra is a drug owned by Avion Pharmaceuticals Llc. It is used for treating iron deficiency. Balcoltra uses Ethinyl Estradiol; Levonorgestrel as an active ingredient. Balcoltra was launched by Avion Pharms in 2018.
Approval Date:
Balcoltra was approved by FDA for market use on 09 January, 2018.
Active Ingredient:
Balcoltra uses Ethinyl Estradiol; Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Levonorgestrel ingredient
Treatment:
Balcoltra is used for treating iron deficiency.
Dosage:
Balcoltra is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.02MG;0.1MG | TABLET | Prescription | ORAL |