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Sugammadex sodium - Generic Drug Details
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What are the generic sources for sugammadex sodium and what is the scope of patent protection?
Sugammadex sodium
is the generic ingredient in one branded drug marketed by Organon Sub Merck and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sugammadex sodium has fifty-six patent family members in thirty countries.
There are two drug master file entries for sugammadex sodium. One supplier is listed for this compound.
Summary for sugammadex sodium
International Patents: | 56 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 18 |
Clinical Trials: | 7 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sugammadex sodium |
DailyMed Link: | sugammadex sodium at DailyMed |
Recent Clinical Trials for sugammadex sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ministry of Food and Drug Safety, Korea | Phase 2 |
Seoul National University Hospital | Phase 2 |
Merck Canada Inc. | Phase 4 |
Pharmacology for sugammadex sodium
Paragraph IV (Patent) Challenges for SUGAMMADEX SODIUM
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
BRIDION | SOLUTION;INTRAVENOUS | sugammadex sodium | 022225 | 2019-12-16 |
US Patents and Regulatory Information for sugammadex sodium
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 | 022225-001 | 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 | 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 sugammadex sodium
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 sugammadex sodium
Country | Patent Number | Estimated Expiration |
---|---|---|
Norway | 328790 | Start Trial |
Slovakia | 7262002 | Start Trial |
Israel | 147887 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sugammadex sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1259550 | 122008000068 | Germany | Start Trial | PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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