Brevibloc In Plastic Container is a drug owned by Baxter Healthcare Corp. It is protected by 4 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 Jul 12, 2021. Details of Brevibloc In Plastic Container'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). | |||
| US6310094 | Ready-to-use esmolol solution |
Jan, 2021
(3 years ago) |
Expired
|
| US6528540 | Esmolol formulation |
Jan, 2021
(3 years ago) |
Expired
|
|
US6528540 (Pediatric) | Esmolol formulation |
Jul, 2021
(3 years ago) |
Expired
|
|
US6310094 (Pediatric) | Ready-to-use esmolol solution |
Jul, 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 Brevibloc In Plastic Container's patents.
Latest Legal Activities on Brevibloc In Plastic Container's Patents
Given below is the list of recent legal activities going on the following patents of Brevibloc In Plastic Container.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| File Marked Found | 07 Aug, 2018 | US6310094 |
| Termination or Final Written Decision | 27 Apr, 2016 | US6310094 |
| Termination or Final Written Decision | 27 Apr, 2016 | US6528540 |
| Petition Requesting Trial | 19 Nov, 2015 | US6310094 |
| Petition Requesting Trial | 19 Nov, 2015 | US6528540 |
| File Marked Lost | 23 Mar, 2005 | US6310094 |
| Mail Miscellaneous Communication to Applicant | 18 Dec, 2003 | US6528540 |
| Miscellaneous Communication to Applicant - No Action Count | 17 Dec, 2003 | US6528540 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Mar, 2003 | US6528540 |
| Recordation of Patent Grant Mailed Critical | 04 Mar, 2003 | US6528540 |
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 Brevibloc In Plastic Container and ongoing litigations to help you estimate the early arrival of Brevibloc In Plastic Container generic.
Brevibloc In Plastic Container's Litigations
Brevibloc In Plastic Container has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 19, 2015, against patent number US6528540. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Baxter International Inc. as the respondent. Click below to track the latest information on how companies are challenging Brevibloc In Plastic Container's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6310094 | November, 2015 |
Terminated-Denied
(27 Apr, 2016) | Baxter International Inc. | Mylan Pharmaceuticals Inc. |
| US6528540 | November, 2015 |
Terminated-Denied
(27 Apr, 2016) | Baxter International Inc. | Mylan Pharmaceuticals Inc. |
US patents provide insights into the exclusivity only within the United States, but Brevibloc In Plastic Container 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 Brevibloc In Plastic Container's family patents as well as insights into ongoing legal events on those patents.
Brevibloc In Plastic Container's Family Patents
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Generic Launch
Generic Release Date:
Brevibloc In Plastic Container's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 12, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Brevibloc In Plastic Container Generics:
Esmolol Hydrochloride is the generic name for the brand Brevibloc In Plastic Container. 10 different companies have already filed for the generic of Brevibloc In Plastic Container, with Eugia Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Brevibloc In Plastic Container's generic
How can I launch a generic of Brevibloc In Plastic Container before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Brevibloc In Plastic Container's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Brevibloc In Plastic Container'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 Brevibloc In Plastic Container -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/mL, 10 mL vial | |||||
| 10 mg/mL, 250 mL infusion bags and 20 mg/mL, 100 mL infusion bags | 31 Jan, 2014 | 1 | 08 Jun, 2016 | 12 Jan, 2021 | Extinguished |
Brevibloc In Plastic Container Competitors
Understanding your competition is essential for market success. There are several other brand drugs using the same active ingredient (Esmolol Hydrochloride) as Brevibloc In Plastic Container. 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 | ||
|---|---|---|---|
| Baxter Hlthcare |
| ||
| Hq Spclt Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Esmolol Hydrochloride, Brevibloc In Plastic Container's active ingredient. Check the complete list of approved generic manufacturers for Brevibloc In Plastic Container
About Brevibloc In Plastic Container
Brevibloc In Plastic Container is a drug owned by Baxter Healthcare Corp. Brevibloc In Plastic Container uses Esmolol Hydrochloride as an active ingredient. Brevibloc In Plastic Container was launched by Baxter Hlthcare in 1988.
Approval Date:
Brevibloc In Plastic Container was approved by FDA for market use on 15 August, 1988.
Active Ingredient:
Brevibloc In Plastic Container uses Esmolol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Esmolol Hydrochloride ingredient
Dosage:
Brevibloc In Plastic Container is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM/100ML | INJECTABLE | Prescription | INJECTION |