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

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 214103


✉ Email this page to a colleague

« Back to Dashboard


NDA 214103 describes OXLUMO, 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 OXLUMO profile page.

The generic ingredient in OXLUMO is lumasiran sodium. One supplier is listed for this compound. Additional details are available on the lumasiran sodium profile page.
Summary for 214103
Tradename:OXLUMO
Applicant:Alnylam Pharms Inc
Ingredient:lumasiran sodium
Patents:14
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214103
Generic Entry Date for 214103*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*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.

Suppliers and Packaging for NDA: 214103
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXLUMO lumasiran sodium SOLUTION;SUBCUTANEOUS 214103 NDA Alnylam Pharmaceuticals, Inc. 71336-1002 71336-1002-1 1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)
Approval Date:Nov 23, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 6, 2025
Regulatory Exclusivity Use:EXPANDED INDICATION TO INCLUDE LOWERING OF PLASMA OXALATE LEVELS IN ADULT AND PEDIATRIC PATIENTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1)
Regulatory Exclusivity Expiration:Nov 23, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 6, 2029
Regulatory Exclusivity Use:TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) TO LOWER PLASMA OXALATE LEVELS IN PEDIATRIC AND ADULT PATIENTS

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.