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Last Updated: August 11, 2022

XATMEP Drug Patent Profile


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Which patents cover Xatmep, 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-five 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

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Recent Clinical Trials for XATMEP

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SponsorPhase
National Cancer Institute (NCI)Phase 2

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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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS

Methotrexate composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA

Methotrexate composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methotrexate composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA

Methotrexate composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS

Methotrexate composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methotrexate composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

TREATMENT OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA AS A COMPONENT OF A COMBINATION CHEOMOTHERAPY MAINTENANCE REGIMEN
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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.