DrugPatentWatch Database Preview
ONPATTRO Drug Profile
When do Onpattro patents expire, and when can generic versions of Onpattro launch?
Onpattro is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are twenty-one patents protecting this drug.
This drug has four hundred and fifteen patent family members in thirty-two countries.
The generic ingredient in ONPATTRO is patisiran sodium. One supplier is listed for this compound. Additional details are available on the patisiran sodium profile page.
Summary for ONPATTRO
| International Patents: | 415 |
| US Patents: | 21 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for ONPATTRO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ONPATTRO |
| DailyMed Link: | ONPATTRO at DailyMed |
Generic Entry Opportunity Date for ONPATTRO
Generic Entry Date for ONPATTRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*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.
Recent Litigation for ONPATTRO
Identify potential future generic entrants
PTAB Litigation
| Petitioner | Date |
|---|---|
| Moderna Therapeutics, Inc. | 2019-01-09 |
| Moderna Therapeutics, Inc. | 2018-03-05 |
US Patents and Regulatory Information for ONPATTRO
| 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 | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | 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 ONPATTRO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2028278 | Start Trial |
| Slovenia | 2348134 | Start Trial |
| Japan | 2011516586 | Start Trial |
| Australia | 2007214287 | Start Trial |
| Japan | 5006485 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03070904 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ONPATTRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2937418 | 3/2019 | Austria | Start Trial | PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 (MITTEILUNG) 20180829 |
| 2937418 | PA2019501 | Lithuania | Start Trial | PRODUCT NAME: PATISIRANAS; REGISTRATION NO/DATE: EU/1/18/1320 20180827 |
| 2937418 | 1990004-2 | Sweden | Start Trial | PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829 |
| 2937418 | LUC00098 | Luxembourg | Start Trial | PRODUCT NAME: PATISIRAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ONPATTRO ); AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829 |
| 2937418 | 300965 | Netherlands | Start Trial | PRODUCT NAME: -; REGISTRATION NO/DATE: EU/1/18/1320 20180829 |
| 2937418 | CA 2019 00005 | Denmark | Start Trial | PRODUCT NAME: PATISIRAN... (NAVN FOR LANGT); REG. NO/DATE: EU/1/18/1320 20180829 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
