XATMEP Drug Patent Profile
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Which patents cover Xatmep, and when can generic versions of Xatmep launch?
Xatmep is a drug marketed by Azurity and is included in one NDA. There are six 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-eight 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
| International Patents: | 3 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,415 |
| 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 |
US Patents and Regulatory Information for XATMEP
XATMEP is protected by eight US patents and two FDA Regulatory Exclusivities.
Patents protecting XATMEP
Methotrexate composition
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Patented Use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
Methotrexate composition
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Patented Use: TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS
Methotrexate composition
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Methotrexate composition
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Patented Use: TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS
Methotrexate composition
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Patented Use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
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Methotrexate composition
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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 | 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
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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.
ISSN: 2162-2639
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