OTREXUP Drug Patent Profile
✉ Email this page to a colleague
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. Four 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for OTREXUP?
- What are the global sales for OTREXUP?
- What is Average Wholesale Price for OTREXUP?
Summary for OTREXUP
International Patents: | 37 |
US Patents: | 14 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 137 |
Clinical Trials: | 7 |
Patent Applications: | 4,383 |
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 |
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 for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-004 | Oct 11, 2013 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-006 | Mar 24, 2016 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-006 | Mar 24, 2016 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-008 | Mar 24, 2016 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Otter Pharms | OTREXUP PFS | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-010 | May 31, 2017 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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
See the table below for patents covering OTREXUP around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20070117543 | PREFILLED NEEDLE ASSISTED JET INJECTOR | ⤷ Try for Free |
Japan | 5216328 | ⤷ Try for Free | |
Austria | 240756 | ⤷ Try for Free | |
Canada | 2755779 | SYSTEME D'INJECTION D'AGENTS DANGEREUX (HAZARDOUS AGENT INJECTION SYSTEM) | ⤷ Try for Free |
Japan | 2008528126 | ⤷ Try for Free | |
China | 1323230 | ⤷ Try for Free | |
Japan | 4299466 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Otrexup
More… ↓