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BRIDION Drug Profile
» See Plans and Pricing
When do Bridion patents expire, and when can generic versions of Bridion launch?
Bridion is a drug marketed by Organon Sub Merck and is included in one NDA. There are three patents protecting this drug.
This drug has fifty-six patent family members in thirty countries.
The generic ingredient in BRIDION is sugammadex sodium. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sugammadex sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Bridion
Bridion was eligible for patent challenges on December 15, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 27, 2026. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for BRIDION
| International Patents: | 56 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 18 |
| Clinical Trials: | 50 |
| Patent Applications: | 146 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BRIDION |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRIDION |
| What excipients (inactive ingredients) are in BRIDION? | BRIDION excipients list |
| DailyMed Link: | BRIDION at DailyMed |
Generic Entry Opportunity Date for BRIDION
Generic Entry Date for BRIDION*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for BRIDION
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Temple University | Phase 4 |
| Tetsuro Sakai | Phase 1 |
| University of California, Los Angeles | Phase 4 |
Pharmacology for BRIDION
Paragraph IV (Patent) Challenges for BRIDION
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BRIDION | SOLUTION;INTRAVENOUS | sugammadex sodium | 022225 | 2019-12-16 |
US Patents and Regulatory Information for BRIDION
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for BRIDION
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | Start Trial | Start Trial |
| Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | Start Trial | Start Trial |
| Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BRIDION
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1241576 | Start Trial |
| Peru | 20010902 | Start Trial |
| Spain | 2237496 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BRIDION
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1259550 | 2008C/047 | Belgium | Start Trial | PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729 |
| 1259550 | 300356 | Netherlands | Start Trial | |
| 1259550 | 91501 | Luxembourg | Start Trial | 91501, EXPIRES: 20230725 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
