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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 022225

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NDA 022225 describes BRIDION, which is a drug marketed by Organon Sub Merck and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the BRIDION profile page.

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.
Summary for 022225
Tradename:BRIDION
Applicant:Organon Sub Merck
Ingredient:sugammadex sodium
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022225
Generic Entry Date for 022225*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 022225
Suppliers and Packaging for NDA: 022225
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225 NDA Merck Sharp & Dohme Corp. 0006-5423 0006-5423-12 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-12) > 2 mL in 1 VIAL, SINGLE-DOSE (0006-5423-02)
BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225 NDA Merck Sharp & Dohme Corp. 0006-5423 0006-5423-15 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-15) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-5423-05)
Paragraph IV (Patent) Challenges for 022225
Tradename Dosage Ingredient NDA Submissiondate
BRIDION SOLUTION;INTRAVENOUS sugammadex sodium 022225 2019-12-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date:Dec 15, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 15, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jan 27, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:REVERSAL OF NEUROMUSCULAR BLOCKAGE INDUCED BY ROCURONIUM BROMIDE OR VECURONIUM BROMIDE
Patent:  Start TrialPatent Expiration:Aug 7, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:REVERSAL OF NEUROMUSCULAR BLOCKAGE INDUCED BY ROCURONIUM BROMIDE OR VECURONIUM BROMIDE

Expired US Patents for NDA 022225

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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

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Serving leading biopharmaceutical companies globally:

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