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Last Updated: November 22, 2024

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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Drug patent expirations by year for otrexup pfs
Recent Clinical Trials for otrexup pfs

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

SponsorPhase
University of Wisconsin, MadisonPhase 1
Virginia Commonwealth UniversityPhase 1
PfizerPhase 1

See all otrexup pfs clinical trials

Pharmacology for otrexup pfs

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
Otter Pharms OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-011 May 31, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Otter Pharms OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-014 May 31, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Otter Pharms OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-013 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
Japan 4299466 ⤷  Sign Up
Japan 5731829 ⤷  Sign Up
Japan 5732039 ⤷  Sign Up
Canada 2755779 SYSTEME D'INJECTION D'AGENTS DANGEREUX (HAZARDOUS AGENT INJECTION SYSTEM) ⤷  Sign Up
Germany 69908140 ⤷  Sign Up
Japan 2002522171 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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