otrexup pfs Drug Patent Profile
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Which patents cover Otrexup Pfs, and what generic alternatives are available?
Otrexup Pfs is a drug marketed by Otter Pharms and is included in one NDA.
The generic ingredient in OTREXUP PFS is methotrexate. There are twenty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
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Summary for otrexup pfs
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 137 |
Clinical Trials: | 7 |
Patent Applications: | 4,338 |
DailyMed Link: | otrexup pfs at DailyMed |
Recent Clinical Trials for otrexup pfs
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vanderbilt University | Phase 1 |
University of Virginia | Phase 1 |
University of Wisconsin, Madison | Phase 1 |
Pharmacology for otrexup pfs
Drug Class | Folate Analog Metabolic Inhibitor |
Mechanism of Action | Folic Acid Metabolism Inhibitors |
US Patents and Regulatory Information for otrexup pfs
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Otter Pharms | OTREXUP PFS | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-009 | May 31, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Otter Pharms | OTREXUP PFS | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-012 | May 31, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Otter Pharms | OTREXUP PFS | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-010 | May 31, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for otrexup pfs
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Nordic Group B.V. | Nordimet | methotrexate | EMEA/H/C/003983 Nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate,moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate. |
Authorised | no | no | no | 2016-08-18 | |
Therakind (Europe) Limited | Jylamvo | methotrexate | EMEA/H/C/003756 In rheumatological and dermatological diseasesActive rheumatoid arthritis in adult patients.Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients.In oncologyMaintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over. |
Authorised | no | no | no | 2017-03-29 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for otrexup pfs
See the table below for patents covering otrexup pfs around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2908027 | ⤷ Sign Up | |
European Patent Office | 1850892 | INJECTEUR A SERINGUE PREREMPLIE ASSISTE D'UNE AIGUILLE (PREFILLED NEEDLE ASSISTED SYRINGE JET INJECTOR) | ⤷ Sign Up |
Japan | 5968976 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |