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ONPATTRO Drug Profile
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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 twenty-nine 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.
US ANDA Litigation and Generic Entry Outlook for Onpattro
Onpattro will be eligible for patent challenges on August 10, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 10, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ONPATTRO
| International Patents: | 429 |
| 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 | 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 | 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 |
|---|---|---|
| Denmark | 2813582 | Start Trial |
| Austria | 450621 | Start Trial |
| Brazil | PI0117341 | 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 | 122018000133 | Germany | Start Trial | PRODUCT NAME: PATISIRAN; 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
