Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 14, 2019

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BRIDION Drug Profile

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Which patents cover Bridion, 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 will be eligible for patent challenges on December 15th, 2019. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 27th, 2021. This may change due to patent challenges or generic licensing.

Drug patent expirations by year for BRIDION
Drug Prices for BRIDION

See drug prices for BRIDION

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

SponsorPhase
University of South FloridaPhase 3
Guangzhou General Hospital of Guangzhou Military CommandPhase 4
Yonsei UniversityN/A

See all BRIDION clinical trials

Pharmacology for BRIDION
Synonyms for BRIDION
1202253-72-2
343306-71-8
343306-79-6
361LPM2T56
862667-16-1
AC-30384
Bridion (TN)
CHEBI:90952
CHEBI:90953
D05940
DB06206
ERJ6X2MXV7
EX-A2600
gamma-Cyclodextrin, 6A,6B,6C,6D,6E,7F,6G,6H-octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,7F,6G,6H-octathio-, octasodium salt
MK-8616
Octasodium 6,6',6'',6''',6'''',6''''',6'''''',6'''''''-octakis-S-(2-carboxylatoethyl)-6,6',6'',6''',6'''',6''''',6'''''',6'''''''-octathiocyclo-alpha-(1-4)-D-octaglucopyranoside
Org 25969
ORG-25969
SCH-900616
SCHEMBL13917069
Sugammadex
Sugammadex [USAN:INN:BAN]
Sugammadex Sodium
Sugammadex sodium (JAN/USAN)
Sugammadex sodium [USAN:JAN]
UNII-361LPM2T56
UNII-ERJ6X2MXV7

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   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
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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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 SPC031/2008 Ireland   Start Trial SPC031/2008: 20090428, EXPIRES: 20230724
1259550 340 Finland   Start Trial
1259550 SPC/GB08/057 United Kingdom   Start Trial PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
1259550 08C0052 France   Start Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550 C01259550/01 Switzerland   Start Trial FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Express Scripts
Harvard Business School
Dow
McKinsey

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 verifification 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.