BRIDION Drug Patent Profile
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When do Bridion patents expire, and when can generic versions of Bridion launch?
Bridion is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has forty-two patent family members in thirty countries.
The generic ingredient in BRIDION is sugammadex sodium. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sugammadex sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bridion
A generic version of BRIDION was approved as sugammadex sodium by ASPIRO on June 9th, 2023.
Summary for BRIDION
| International Patents: | 42 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 65 |
| Patent Applications: | 43 |
| 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 |
Recent Clinical Trials for BRIDION
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Korea University Ansan Hospital | Phase 4 |
| Seoul National University Hospital | N/A |
| Radboud University Medical Center | Phase 2 |
Pharmacology for BRIDION
Anatomical Therapeutic Chemical (ATC) Classes for BRIDION
Paragraph IV (Patent) Challenges for BRIDION
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BRIDION | Injection | sugammadex sodium | 200 mg/2 mL and 500 mg/5 mL | 022225 | 14 | 2019-12-16 |
US Patents and Regulatory Information for BRIDION
BRIDION is protected by one US patents and three FDA Regulatory Exclusivities.
Patents protecting BRIDION
6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK
FDA Regulatory Exclusivity protecting BRIDION
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P146 TO FULFILL THE REQUIREMENTS OF PMR 3003-4
Exclusivity Expiration: ⤷ Try a Trial
REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P145
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | AP | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | AP | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | AP | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | AP | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
|---|---|---|---|---|---|---|---|
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BRIDION
See the table below for patents covering BRIDION around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 203012 | ⤷ Try a Trial | |
| Netherlands | 300356 | ⤷ Try a Trial | |
| Brazil | 0013126 | ⤷ Try a Trial | |
| Czech Republic | 298206 | Deriváty 6-merkaptocyklodextrinu a farmaceutický prostredek (6-Mercaptocyclodextrin derivatives and pharmaceutical composition) | ⤷ Try a Trial |
| Luxembourg | 91501 | ⤷ Try a Trial | |
| Brazil | 0015947 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BRIDION
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1259550 | 08C0052 | France | ⤷ Try a Trial | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
| 1259550 | SPC031/2008 | Ireland | ⤷ Try a Trial | SPC031/2008: 20090428, EXPIRES: 20230724 |
| 1259550 | 340 | Finland | ⤷ Try a Trial | |
| 1259550 | SPC/GB08/057 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725 |
| 1259550 | CA 2009 00002 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM |
| 1259550 | 2008C/047 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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