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Last Updated: November 22, 2024

XROMI Drug Patent Profile


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When do Xromi patents expire, and when can generic versions of Xromi launch?

Xromi is a drug marketed by Nova Labs Ltd and is included in one NDA.

The generic ingredient in XROMI is hydroxyurea. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Xromi

A generic version of XROMI was approved as hydroxyurea by BARR on October 16th, 1998.

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Summary for XROMI
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Patent Applications: 1,706
What excipients (inactive ingredients) are in XROMI?XROMI excipients list
DailyMed Link:XROMI at DailyMed
Drug patent expirations by year for XROMI
Pharmacology for XROMI
Drug ClassAntimetabolite

US Patents and Regulatory Information for XROMI

XROMI is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting XROMI

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Exclusivity Expiration: ⤷  Sign Up

TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS AGED 6 MONTHS OF AGE TO LESS THAN 2 YEARS, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISES
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nova Labs Ltd XROMI hydroxyurea SOLUTION;ORAL 216593-001 Apr 4, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nova Labs Ltd XROMI hydroxyurea SOLUTION;ORAL 216593-001 Apr 4, 2024 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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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.