OTREXUP Drug Patent Profile
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Which patents cover Otrexup, and when can generic versions of Otrexup launch?
Otrexup is a drug marketed by Otter Pharms and is included in one NDA. There are fourteen patents protecting this drug.
This drug has thirty-seven patent family members in fourteen countries.
The generic ingredient in OTREXUP is methotrexate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
DrugPatentWatch® Generic Entry Outlook for Otrexup
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 24, 2026. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for OTREXUP
International Patents: | 37 |
US Patents: | 14 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 137 |
Clinical Trials: | 7 |
Patent Applications: | 4,326 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for OTREXUP |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OTREXUP |
What excipients (inactive ingredients) are in OTREXUP? | OTREXUP excipients list |
DailyMed Link: | OTREXUP at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OTREXUP
Generic Entry Date for OTREXUP*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for OTREXUP
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Virginia Commonwealth University | Phase 1 |
Pfizer | Phase 1 |
Vanderbilt University | Phase 1 |
Pharmacology for OTREXUP
Drug Class | Folate Analog Metabolic Inhibitor |
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for OTREXUP
US Patents and Regulatory Information for OTREXUP
OTREXUP is protected by fourteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OTREXUP is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting OTREXUP
Injector safety device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prefilled syringe injector
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prefilled syringe jet injector
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Hazardous agent injection system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE
Prefilled syringe jet injector
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Hazardous agent injection system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE
Injector safety device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Hazardous agent injection system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE
Hazardous agent injection system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE
Prefilled syringe jet injector
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prefilled syringe jet injector
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Injector safety device
Patent Number: ⤷ Try a Trial
Patent 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-003 | Oct 11, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-004 | Oct 11, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-006 | Mar 24, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-006 | Mar 24, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-008 | Mar 24, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otter Pharms | OTREXUP PFS | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-010 | May 31, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | 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 |
Expired US Patents for OTREXUP
EU/EMA Drug Approvals for OTREXUP
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
When does loss-of-exclusivity occur for OTREXUP?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Brazil
Patent: 0614025
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 95730
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1132820
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 50892
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 50892
Estimated Expiration: ⤷ Try a Trial
Patent: 95009
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 50892
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 42286
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4765
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 16328
Estimated Expiration: ⤷ Try a Trial
Patent: 08528126
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 50892
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 070117543
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 16135
Estimated Expiration: ⤷ Try a Trial
Patent: 08027
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering OTREXUP around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2009114542 | ⤷ Try a Trial | |
South Korea | 20070117543 | PREFILLED NEEDLE ASSISTED JET INJECTOR | ⤷ Try a Trial |
European Patent Office | 2408493 | SYSTÈME D'INJECTION D'AGENTS DANGEREUX (HAZARDOUS AGENT INJECTION SYSTEM) | ⤷ Try a Trial |
European Patent Office | 3636301 | DISPOSITIF DE SÉCURITÉ D'INJECTEUR (INJECTOR SAFETY DEVICE) | ⤷ Try a Trial |
Japan | 2012521224 | ⤷ Try a Trial | |
Spain | 2752152 | ⤷ Try a Trial | |
Spain | 2908027 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |