Givosiran sodium - Generic Drug Details
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What are the generic sources for givosiran sodium and what is the scope of freedom to operate?
Givosiran sodium
is the generic ingredient in one branded drug marketed by Alnylam Pharms Inc and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Givosiran sodium has four hundred and thirteen patent family members in forty-two countries.
One supplier is listed for this compound.
Summary for givosiran sodium
| International Patents: | 413 |
| US Patents: | 14 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| What excipients (inactive ingredients) are in givosiran sodium? | givosiran sodium excipients list |
| DailyMed Link: | givosiran sodium at DailyMed |
US Patents and Regulatory Information for givosiran sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 givosiran sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for givosiran sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Philippines | 12016500574 | COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2009082607 | ⤷ Sign Up | |
| Netherlands | 301061 | ⤷ Sign Up | |
| Taiwan | I768330 | ⤷ Sign Up | |
| Japan | 2019147846 | オリゴヌクレオチドの送達剤としての糖質コンジュゲート (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES) | ⤷ Sign Up |
| Japan | 2011505425 | ⤷ Sign Up | |
| Australia | 2018203098 | COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for givosiran sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3052628 | PA2020527 | Lithuania | ⤷ Sign Up | PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302 |
| 3052628 | PA2020527,C3052628 | Lithuania | ⤷ Sign Up | PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302 |
| 3052628 | CR 2020 00042 | Denmark | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1428 20200304 |
| 3052628 | 2090037-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1428 20200304 |
| 3052628 | LUC00175 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1428 20200304 |
| 3052628 | 2020029 | Norway | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1428 20200306 |
| 3052628 | 20C1040 | France | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1428 20200304; FIRST REGISTRATION: - EU/1/20/1428 20200304 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
