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Sugammadex sodium - Generic Drug Details
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: | 15 |
| 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 |
|---|---|
| Seoul National University Hospital | Phase 2 |
| Ministry of Food and Drug Safety, Korea | 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 | 022225-002 | 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 | ||||
| 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 |
International Patents for sugammadex sodium
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 122008000068 | Start Trial |
| Norway | 20022522 | Start Trial |
| China | 1370073 | Start Trial |
| Hong Kong | 1049489 | Start Trial |
| Japan | 4563972 | 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 | 300356 | Netherlands | Start Trial | |
| 1259550 | CA 2009 00002 | Denmark | Start Trial | PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM |
| 1259550 | SPC031/2008 | Ireland | Start Trial | SPC031/2008: 20090428, EXPIRES: 20230724 |
| 1259550 | 47/2008 | Austria | Start Trial | PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; 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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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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