Otrexup is a drug owned by Cosette Pharmaceuticals Inc. It is protected by 20 US drug patents filed from 2013 to 2025. Out of these, 10 drug patents are active and 10 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 27, 2031. Details of Otrexup's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8814834 | Injector safety device |
May, 2031
(4 years from now) | Active |
| US8579865 | Hazardous agent injection system |
Mar, 2030
(3 years from now) | Active |
| US9421333 | Hazardous agent injection system |
Mar, 2030
(3 years from now) | Active |
| US8945063 | Hazardous agent injection system |
Mar, 2030
(3 years from now) | Active |
| US11497753 | Hazardous agent injection system |
Mar, 2030
(3 years from now) | Active |
| US12357642 | Hazardous Agent Injection System |
Mar, 2030
(3 years from now) | Active |
| US8480631 | Hazardous agent injection system |
Mar, 2030
(3 years from now) | Active |
| US9867949 | Injector safety device |
Mar, 2029
(2 years from now) | Active |
| US10709844 | Injector safety device |
Mar, 2029
(2 years from now) | Active |
| US11684723 | Injector safety device |
Mar, 2029
(2 years from now) | Active |
| US8021335 | Prefilled syringe jet injector |
Oct, 2026
(9 days ago) |
Expired
|
| US9629959 | Prefilled syringe jet injector |
Jan, 2026
(8 months ago) |
Expired
|
| US9533102 | Prefilled syringe jet injector |
Jan, 2026
(8 months ago) |
Expired
|
| US11446441 | Prefilled syringe injector |
Jan, 2026
(8 months ago) |
Expired
|
| US8562564 | Prefilled syringe jet injector |
Jan, 2026
(8 months ago) |
Expired
|
| US6746429 | Needle assisted jet injector |
Apr, 2020
(6 years ago) |
Expired
|
| USRE44847 | Needle assisted jet injector |
Aug, 2019
(7 years ago) |
Expired
|
| USRE44846 | Needle assisted jet injector |
Aug, 2019
(7 years ago) |
Expired
|
| US7744582 | Needle assisted jet injector |
Aug, 2019
(7 years ago) |
Expired
|
| US7776015 | Needle assisted jet injector |
Aug, 2019
(7 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Otrexup's patents.
Latest Legal Activities on Otrexup's Patents
Given below is the list of recent legal activities going on the following patents of Otrexup.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 26 Feb, 2026 | US8814834 |
| Recordation of Patent Grant Mailed | 22 Jul, 2025 | US12357642 |
| Email Notification | 16 Jul, 2025 | US12357642 |
| Patent eGrant Notification | 15 Jul, 2025 | US12357642 |
| Mail Patent eGrant Notification | 15 Jul, 2025 | US12357642 |
| Patent Issue Date Used in PTA Calculation | 15 Jul, 2025 | US12357642 |
| Recordation of Patent eGrant | 15 Jul, 2025 | US12357642 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Jul, 2025 | US9867949 |
| Email Notification | 03 Jul, 2025 | US12357642 |
| Issue Notification Mailed | 02 Jul, 2025 | US12357642 |
Several oppositions have been filed on Otrexup's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Otrexup's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Otrexup patents.
Otrexup's Oppositions Filed in EPO
Otrexup has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 16, 2016, by Ypsomed Ag. This opposition was filed on patent number EP09719763A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP19150366A | Sep, 2022 | Bandpay & Greuter | Granted and Under Opposition |
| EP06719329A | Oct, 2019 | Bandpay & Greuter | Patent maintained as amended |
| EP09719763A | Jun, 2016 | Ypsomed AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Otrexup is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Otrexup's family patents as well as insights into
ongoing legal events
on those patents.
Otrexup's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Otrexup:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Otrexup's generic launch date based on the expiry of its last outstanding patent is estimated to be May 27, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Otrexup Generics:
There are no approved generic versions for Otrexup as of now.
Alternative Brands for Otrexup
Otrexup which is used for treating conditions such as cancer, rheumatoid arthritis, and certain types of psoriasis., has several other brand drugs in the same treatment category and using the same active ingredient (Methotrexate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Medexus |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Methotrexate. Given below is the list of those drugs and companies owning them.
About Otrexup
Otrexup is a drug owned by Cosette Pharmaceuticals Inc. It is used for treating conditions such as cancer, rheumatoid arthritis, and certain types of psoriasis. Otrexup uses Methotrexate as an active ingredient. Otrexup was launched by Cosette in 2014.
Approval Date:
Otrexup was approved by FDA for market use on 07 November, 2014.
Active Ingredient:
Otrexup uses Methotrexate as the active ingredient. Check out other Drugs and Companies using Methotrexate ingredient
Treatment:
Otrexup is used for treating conditions such as cancer, rheumatoid arthritis, and certain types of psoriasis.
Dosage:
Otrexup is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5MG/0.4ML (12.5MG/0.4ML) | SOLUTION | Discontinued | SUBCUTANEOUS |
| 7.5MG/0.4ML (7.5MG/0.4ML) | SOLUTION | Discontinued | SUBCUTANEOUS |
| 15MG/0.4ML (15MG/0.4ML) | SOLUTION | Discontinued | SUBCUTANEOUS |
| 22.5MG/0.4ML (22.5MG/0.4ML) | SOLUTION | Discontinued | SUBCUTANEOUS |
| 25MG/0.4ML (25MG/0.4ML) | SOLUTION | Discontinued | SUBCUTANEOUS |
| 20MG/0.4ML (20MG/0.4ML) | SOLUTION | Discontinued | SUBCUTANEOUS |
| 17.5MG/0.4ML (17.5MG/0.4ML) | SOLUTION | Discontinued | SUBCUTANEOUS |
| 10MG/0.4ML (10MG/0.4ML) | SOLUTION | Discontinued | SUBCUTANEOUS |