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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 two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the sugammadex sodium profile page.
The generic ingredient in BRIDION is sugammadex sodium. There are two drug master file entries for this compound. Two suppliers are 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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | ||||
| Approval Date: | Dec 15, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 15, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jan 27, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REVERSAL OF NEUROMUSCULAR BLOCKAGE INDUCED BY ROCURONIUM BROMIDE OR VECURONIUM BROMIDE | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 7, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REVERSAL OF NEUROMUSCULAR BLOCKAGE INDUCED BY ROCURONIUM BROMIDE OR VECURONIUM BROMIDE | ||||||||
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