You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 19, 2025

Details for New Drug Application (NDA): 208534


✉ Email this page to a colleague

« Back to Dashboard


NDA 208534 describes RIVAROXABAN, which is a drug marketed by Alkem Labs Ltd, Lupin Ltd, Aiping Pharm Inc, Alembic, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Biocon Pharma, Breckenridge, Dr Reddys, Invagen Pharms, Macleods Pharms Ltd, MSN, Regcon Holdings, Sciegen Pharms Inc, Sunshine, and Taro, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the RIVAROXABAN profile page.

The generic ingredient in RIVAROXABAN is rivaroxaban. There are thirty-five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
Summary for 208534
Tradename:RIVAROXABAN
Applicant:Dr Reddys
Ingredient:rivaroxaban
Patents:0
Pharmacology for NDA: 208534
Mechanism of ActionFactor Xa Inhibitors
Medical Subject Heading (MeSH) Categories for 208534
Factor Xa Inhibitors
Suppliers and Packaging for NDA: 208534
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVAROXABAN rivaroxaban TABLET;ORAL 208534 ANDA Dr.Reddy's Laboratories, Inc. 43598-981 43598-981-18 180 TABLET in 1 BOTTLE (43598-981-18)
RIVAROXABAN rivaroxaban TABLET;ORAL 208534 ANDA Dr.Reddy's Laboratories, Inc. 43598-981 43598-981-60 60 TABLET in 1 BOTTLE (43598-981-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:May 14, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 14, 2025TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:May 14, 2025TE:ABRLD:No

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
© Copyright 2002-2025 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2025 - 2026
 NCE-1 Patent Challenge Dates 2025 - 2026
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links