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

Last Updated: March 27, 2026

Details for New Drug Application (NDA): 213553


✉ Email this page to a colleague

« Back to Dashboard


NDA 213553 describes FULVESTRANT, which is a drug marketed by Accord Hlthcare, Alembic, Amneal, Apotex, Avyxa Holdings, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in seventeen NDAs. It is available from twenty suppliers. There are three patents protecting this drug. Additional details are available on the FULVESTRANT profile page.

The generic ingredient in FULVESTRANT is fulvestrant. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 213553
Tradename:FULVESTRANT
Applicant:Xiromed
Ingredient:fulvestrant
Patents:0
Pharmacology for NDA: 213553
Mechanism of ActionEstrogen Receptor Antagonists
Selective Estrogen Receptor Modulators
Suppliers and Packaging for NDA: 213553
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 213553 ANDA Northstar Rx, LLC, 16714-070 16714-070-02 2 SYRINGE, GLASS in 1 CARTON (16714-070-02) / 5 mL in 1 SYRINGE, GLASS (16714-070-01)
FULVESTRANT fulvestrant SOLUTION;INTRAMUSCULAR 213553 ANDA Xiromed, LLC 70700-284 70700-284-98 2 SYRINGE, GLASS in 1 CARTON (70700-284-98) / 5 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength250MG/5ML (50MG/ML)
Approval Date:Aug 13, 2021TE:AORLD: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 2002-2026 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
 NCE-1 Patent Challenge Dates 2026 - 2027
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links