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 16th, 1986.
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 |
Recent Clinical Trials for XATMEP
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 2 |
Pharmacology for XATMEP
Drug Class | Folate Analog Metabolic Inhibitor |
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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: ⤷ 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
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
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 | ||||
>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 |
---|---|---|---|
European Patent Office | 2614814 | Composition de mĂ©thotrexate (Methotrexate composition) | ⤷ Try a Trial |
Spain | 2726524 | ⤷ Try a Trial | |
United Kingdom | 201200192 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |