Bridion is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 4 US drug patents filed from 2015 to 2016. Out of these, 1 drug patents are active and 3 have expired. Bridion's patents have been open to challenges since 16 December, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 27, 2026. Details of Bridion'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. | |||
| USRE44733 | 6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block |
Jan, 2026
(1 year, 2 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6949527 | 6-Mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block |
Jan, 2021
(3 years ago) |
Expired
|
| US7265009 | HDP-CVD methodology for forming PMD layer |
Aug, 2020
(4 years ago) |
Expired
|
| US7265099 | Use of chemical chelators as reversal agents for drug-induced neuromuscular block |
Aug, 2020
(4 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 Bridion's patents.
Latest Legal Activities on Bridion's Patents
Given below is the list of recent legal activities going on the following patents of Bridion.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Feb, 2019 | US7265009 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Feb, 2019 | US7265099 |
| Correspondence Address Change Critical | 26 Aug, 2011 | US7265099 |
| Recordation of Patent Grant Mailed Critical | 04 Sep, 2007 | US7265099 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Sep, 2007 | US7265009 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Sep, 2007 | US7265099 |
| Recordation of Patent Grant Mailed Critical | 04 Sep, 2007 | US7265009 |
| Issue Notification Mailed Critical | 15 Aug, 2007 | US7265009 |
| Issue Notification Mailed Critical | 15 Aug, 2007 | US7265099 |
| Dispatch to FDC | 02 Aug, 2007 | US7265009 |
FDA has granted several exclusivities to Bridion. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bridion, 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 Bridion.
Exclusivity Information
Bridion holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Bridion's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 15, 2020 |
| M(M-262) | Jun 09, 2023 |
| M(M-291) | Jan 22, 2024 |
| New Patient Population(NPP) | Jun 25, 2024 |
US patents provide insights into the exclusivity only within the United States, but Bridion 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 Bridion's family patents as well as insights into ongoing legal events on those patents.
Bridion's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bridion's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 27, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bridion Generic API suppliers:
Sugammadex Sodium is the generic name for the brand Bridion. 4 different companies have already filed for the generic of Bridion, with Aspiro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Bridion's generic
How can I launch a generic of Bridion before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bridion's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bridion'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 Bridion -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg/2 mL and 500 mg/5 mL | 16 Dec, 2019 | 14 | 09 Jun, 2023 | 27 Jan, 2026 | Deferred |
About Bridion
Bridion is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is used for reversing drug-induced neuromuscular blockage. Bridion uses Sugammadex Sodium as an active ingredient. Bridion was launched by Msd Sub Merck in 2015.
Approval Date:
Bridion was approved by FDA for market use on 15 December, 2015.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Bridion is 15 December, 2015, its NCE-1 date is estimated to be 16 December, 2019.
Active Ingredient:
Bridion uses Sugammadex Sodium as the active ingredient. Check out other Drugs and Companies using Sugammadex Sodium ingredient
Treatment:
Bridion is used for reversing drug-induced neuromuscular blockage.
Dosage:
Bridion is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |
| EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |