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 two branded drugs marketed by Msd Sub Merck, Aspiro, and Zydus Pharms, and is included in three NDAs. 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. Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for sugammadex sodium
International Patents: | 42 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 32 |
Clinical Trials: | 10 |
Patent Applications: | 89 |
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 |
---|---|
Korea University Ansan Hospital | Phase 4 |
YingHsuanTai | N/A |
Zhejiang Cancer Hospital | N/A |
Generic filers with tentative approvals for SUGAMMADEX SODIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 500MG/5ML(100MG/ML) | INJECTABLE;INJECTION |
⤷ Sign Up | ⤷ Sign Up | 200MG/2ML(100MG/ML) | INJECTABLE;INJECTION |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
Zydus Pharms | SUGAMMADEX SODIUM | sugammadex sodium | SOLUTION;INTRAVENOUS | 214290-001 | Oct 4, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Pharms | SUGAMMADEX SODIUM | sugammadex sodium | SOLUTION;INTRAVENOUS | 214290-002 | Oct 4, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 |
---|---|---|---|---|---|---|---|
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-002 | Dec 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sugammadex sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Colombia | 5251450 | DERIVADOS DE 6-MERCAPTO-CICLODEXTRINA | ⤷ Sign Up |
Portugal | 1259550 | ⤷ Sign Up | |
Russian Federation | 2260013 | ПРОИЗВОДНЫЕ 6-МЕРКАПТОЦИКЛОДЕКСТРИНА: РЕВЕРСИРУЮЩИЕ АГЕНТЫ ДЛЯ ИНДУЦИРОВАННОЙ ЛЕКАРСТВЕННЫМ СРЕДСТВОМ НЕЙРОМЫШЕЧНОЙ БЛОКАДЫ (DERIVATIVES OF 6-MERCAPTOCYCLODEXTRIN: REVERSING AGENTS FOR DRUG- INDUCED NEUROMUSCULAR BLOCKADE) | ⤷ Sign Up |
Japan | 3880041 | ⤷ Sign Up | |
Japan | 2006348301 | 6-MERCAPTO-CYCLODEXTRIN DERIVATIVE: REVERSAL AGENT FOR DRUG-INDUCED NEUROMUSCULAR BLOCK | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sugammadex sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1259550 | 122008000068 | Germany | ⤷ Sign Up | PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
1259550 | SPC031/2008 | Ireland | ⤷ Sign Up | SPC031/2008: 20090428, EXPIRES: 20230724 |
1259550 | 47/2008 | Austria | ⤷ Sign Up | 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 |
1259550 | C01259550/01 | Switzerland | ⤷ Sign Up | FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL |
1259550 | CA 2009 00002 | Denmark | ⤷ Sign Up | PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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