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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. Two suppliers are 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: | 2 |
| Bulk Api Vendors: | 12 |
| Clinical Trials: | 6 |
| 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 |
Recent Litigation for sugammadex sodium
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| MERCK SHARP & DOHME B v. v. GLAND PHARMA LIMITED | 2020-03-12 |
Synonyms for sugammadex sodium
| 343306-71-8 |
| 343306-79-6 |
| AC-30384 |
| AK683673 |
| Bridion |
| Bridion (TN) |
| CHEBI:90952 |
| CHEMBL2107374 |
| D05940 |
| 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-octaglucop |
| Org 25969 |
| ORG-25969 |
| SCH-900616 |
| Sugammadex octasodium salt |
| Sugammadex sodium (JAN/USAN) |
| Sugammadex sodium [USAN:JAN] |
| UNII-ERJ6X2MXV7 |
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 | 022225-001 | 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 | Y | Y | 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 |
|---|---|---|
| Luxembourg | 91501 | Start Trial |
| Hong Kong | 1049489 | Start Trial |
| Germany | 122008000068 | Start Trial |
| China | 1402737 | Start Trial |
| Norway | 328790 | Start Trial |
| Peru | 20010902 | Start Trial |
| South Korea | 100716524 | 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 | SZ 47/2008 | Austria | Start Trial | PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRÄGLICHES SALZ HIERVON |
| 1259550 | 08C0052 | France | Start Trial | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
| 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 | 340 | Finland | Start Trial | |
| 1259550 | SPC031/2008 | Ireland | Start Trial | SPC031/2008: 20090428, EXPIRES: 20230724 |
| 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 | 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 |
