Sugammadex sodium - Generic Drug Details
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What are the generic drug 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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Sugammadex sodium has forty-two patent family members in thirty countries.
There are two drug master file entries for sugammadex sodium. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for sugammadex sodium
International Patents: | 42 |
US Patents: | 1 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 8 |
Patent Applications: | 126 |
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 |
---|---|
YingHsuanTai | N/A |
Ministry of Food and Drug Safety, Korea | Phase 2 |
Seoul National University Hospital | Phase 2 |
Generic filers with tentative approvals for SUGAMMADEX SODIUM
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for sugammadex sodium
Anatomical Therapeutic Chemical (ATC) Classes for sugammadex sodium
Paragraph IV (Patent) Challenges for SUGAMMADEX SODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BRIDION | Injection | sugammadex sodium | 200 mg/2 mL and 500 mg/5 mL | 022225 | 14 | 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | See Plans and Pricing | See Plans and Pricing |
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | See Plans and Pricing | See Plans and Pricing |
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | See Plans and Pricing | See Plans and Pricing |
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | See Plans and Pricing | See Plans and Pricing |
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sugammadex sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 288450 | See Plans and Pricing | |
Mexico | PA02004940 | DERIVADOS DE 6-MERCAPTO-CICLODEXTRIN: AGENTES DE REVERTIMIENTO PARA BLOQUEO NEUROMUSCULAR INDUCIDO POR FARMACOS. (6 MERCAPTO CYCLODEXTRIN DERIVATIVES: REVERSAL AGENTS FOR DRUG INDUCED NEUROMUSCULAR BLOCK.) | See Plans and Pricing |
Czech Republic | 20021814 | See Plans and Pricing | |
Brazil | 0015947 | See Plans and Pricing | |
Norway | 20022522 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sugammadex sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1259550 | CA 2009 00002 | Denmark | See Plans and Pricing | PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM |
1259550 | 2008C/047 | Belgium | See Plans and Pricing | PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729 |
1259550 | 08C0052 | France | See Plans and Pricing | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
1259550 | 340 | Finland | See Plans and Pricing | |
1259550 | 122008000068 | Germany | See Plans and Pricing | PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; 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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