You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 23, 2024

Details for New Drug Application (NDA): 210922


✉ Email this page to a colleague

« Back to Dashboard


NDA 210922 describes ONPATTRO, which is a drug marketed by Alnylam Pharms Inc and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the ONPATTRO profile page.

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 210922
Tradename:ONPATTRO
Applicant:Alnylam Pharms Inc
Ingredient:patisiran sodium
Patents:14
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210922
Generic Entry Date for 210922*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 210922
Suppliers and Packaging for NDA: 210922
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922 NDA Alnylam Pharmaceuticals, Inc. 71336-1000 71336-1000-1 1 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Approval Date:Aug 10, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 10, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Patent:⤷  Sign UpPatent Expiration:Oct 20, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Patent:⤷  Sign UpPatent Expiration:Aug 27, 2035Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Expired US Patents for NDA 210922

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.