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-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 16^th, 1986.

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Summary for XATMEP

International Patents:	3
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	2
Patent Applications:	4,434
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XATMEP
What excipients (inactive ingredients) are in XATMEP?	XATMEP excipients list
DailyMed Link:	XATMEP at DailyMed

Drug patent expirations by year for XATMEP

Recent Clinical Trials for XATMEP

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2

See all XATMEP clinical trials

Pharmacology for XATMEP

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for XATMEP

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA

Methotrexate composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS

Methotrexate composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Methotrexate composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS

Methotrexate composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA

Methotrexate composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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: ⤷ Try a Trial

TREATMENT OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA AS A COMPONENT OF A COMBINATION CHEMOTHERAPY MAINTENANCE REGIMEN
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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.

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Country	Patent Number	Title	Estimated Expiration
United Kingdom	201200192		⤷ Try a Trial
Spain	2726524		⤷ Try a Trial
European Patent Office	2614814	Composition de méthotrexate (Methotrexate composition)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration