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Colorcon
Fish and Richardson
Merck
Boehringer Ingelheim
Medtronic
Johnson and Johnson

Generated: May 20, 2019

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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 three 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.

Drug patent expirations by year for ONPATTRO
Generic Entry Opportunity Date for ONPATTRO
Generic Entry Date for ONPATTRO*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
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.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes ➤ 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

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Supplementary Protection Certificates for ONPATTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2937418 2019C/501 Belgium ➤ Sign Up PRODUCT NAME: PATISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829
2937418 300965 Netherlands ➤ Sign Up PRODUCT NAME: -; REGISTRATION NO/DATE: EU/1/18/1320 20180829
2937418 3/2019 Austria ➤ Sign Up PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 (MITTEILUNG) 20180829
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
AstraZeneca
Colorcon
Mallinckrodt
Argus Health
Covington

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