GIVOSIRAN SODIUM - Generic Drug Details
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What are the generic drug 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 twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Givosiran sodium has three hundred and twenty-four patent family members in forty-three countries.
One supplier is listed for this compound.
Summary for GIVOSIRAN SODIUM
| International Patents: | 324 |
| US Patents: | 12 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GIVOSIRAN SODIUM
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for GIVOSIRAN SODIUM
| Drug Class | Aminolevulinate Synthase 1-directed RNA Interaction Small Interfering RNA |
| Physiological Effect | Decreased RNA Integrity |
Anatomical Therapeutic Chemical (ATC) Classes for GIVOSIRAN SODIUM
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 | 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 | ||
| 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 | ||
| >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 |
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194-001 | Nov 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| 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 |
|---|---|---|---|
| Austria | 292141 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2004041889 | ⤷ Sign Up | |
| Australia | 2003291682 | 2'-METHOXY SUBSTITUTED OLIGOMERIC COMPOUNDS AND COMPOSITIONS FOR USE IN GENE MODULATIONS | ⤷ Sign Up |
| Australia | 2005252663 | Double strand compositions comprising differentially modified strands for use in gene modulation | ⤷ Sign Up |
| Canada | 2505330 | COMPOSES OLIGOMERES CONTENANT UN SUBSTITUT DE SUCRE ET COMPOSITIONS A UTILISER DANS LA MODULATION GENIQUE (SUGAR SURROGATE-CONTAINING OLIGOMERIC COMPOUNDS AND COMPOSITIONS FOR USE IN GENE MODULATION) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2009073809 | ⤷ Sign Up | |
| Cyprus | 1119491 | ⤷ 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 | 2020029 | Norway | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1428 20200306 |
| 3052628 | 724 | Finland | ⤷ Sign Up | |
| 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 | CA 2020 00042 | Denmark | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1428 20200304 |
| 3052628 | 122020000045 | Germany | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1428 20200302 |
| 3052628 | 37/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1428 (MITTEILUNG) 20200304 |
| 3052628 | 132020000000106 | Italy | ⤷ Sign Up | PRODUCT NAME: GIVOSIRAN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GIVLAARI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1428, 20200304 |
| >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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