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Last Updated: June 23, 2024

XATMEP Drug Patent Profile


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When do Xatmep patents expire, and what generic alternatives are available?

Xatmep is a drug marketed by Azurity and is included in one NDA. There are five patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in XATMEP is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Xatmep

A generic version of XATMEP was approved as methotrexate sodium by HIKMA on September 16th, 1986.

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Summary for XATMEP
Drug patent expirations by year for XATMEP
Drug Prices for XATMEP

See drug prices for XATMEP

Recent Clinical Trials for XATMEP

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Phase 2

See all XATMEP clinical trials

Pharmacology for XATMEP

US Patents and Regulatory Information for XATMEP

XATMEP is protected by seven US patents and two FDA Regulatory Exclusivities.

Patents protecting XATMEP

Methotrexate composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA

Methotrexate composition
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS

Methotrexate composition
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Patent Expiration: ⤷  Sign Up

Methotrexate composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS

Methotrexate composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA

Methotrexate composition
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Patent Expiration: ⤷  Sign Up

Methotrexate composition
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FDA Regulatory Exclusivity protecting XATMEP

TREATMENT OF OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PERSISTENT OLIGOARTHRITIS, PSORIATIC JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR UNDIFFERENTIATED ARTHRITIS) & POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS IN CHILDREN 0-16 YRS
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA AS A COMPONENT OF A COMBINATION CHEMOTHERAPY MAINTENANCE REGIMEN
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
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for XATMEP

See the table below for patents covering XATMEP around the world.

Country Patent Number Title Estimated Expiration
United Kingdom 201200192 ⤷  Sign Up
Spain 2726524 ⤷  Sign Up
European Patent Office 2614814 Composition de mĂ©thotrexate (Methotrexate composition) ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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.