Otrexup is a drug owned by Otter Pharmaceuticals Llc. It is protected by 19 US drug patents filed from 2013 to 2023. Out of these, 14 drug patents are active and 5 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
(6 years from now) | Active |
| US8945063 | Hazardous agent injection system |
Mar, 2030
(5 years from now) | Active |
| US9421333 | Hazardous agent injection system |
Mar, 2030
(5 years from now) | Active |
| US8480631 | Hazardous agent injection system |
Mar, 2030
(5 years from now) | Active |
| US11497753 | Hazardous agent injection system |
Mar, 2030
(5 years from now) | Active |
| US8579865 | Hazardous agent injection system |
Mar, 2030
(5 years from now) | Active |
| US9867949 | Injector safety device |
Mar, 2029
(4 years from now) | Active |
| US10709844 | Injector safety device |
Mar, 2029
(4 years from now) | Active |
| US11684723 | Injector safety device |
Mar, 2029
(4 years from now) | Active |
| US8021335 | Prefilled syringe jet injector |
Oct, 2026
(1 year, 10 months from now) | Active |
| US9629959 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 2 months from now) | Active |
| US8562564 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 2 months from now) | Active |
| US9533102 | Prefilled syringe jet injector |
Jan, 2026
(1 year, 2 months from now) | Active |
| US11446441 | Prefilled syringe injector |
Jan, 2026
(1 year, 2 months from now) | Active |
| US6746429 | Needle assisted jet injector |
Apr, 2020
(4 years ago) |
Expired
|
| US7744582 | Needle assisted jet injector |
Aug, 2019
(5 years ago) |
Expired
|
| USRE44847 | Needle assisted jet injector |
Aug, 2019
(5 years ago) |
Expired
|
| US7776015 | Needle assisted jet injector |
Aug, 2019
(5 years ago) |
Expired
|
| USRE44846 | Needle assisted jet injector |
Aug, 2019
(5 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, 8th Year, Large Entity | 01 Jul, 2024 | US9533102 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Feb, 2024 | US9421333 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Jan, 2024 | US10709844 |
| Recordation of Patent eGrant | 27 Jun, 2023 | US11684723 |
| Mail Patent eGrant Notification | 27 Jun, 2023 | US11684723 |
| Email Notification Critical | 27 Jun, 2023 | US11684723 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Jun, 2023 | US11684723 |
| Patent eGrant Notification | 27 Jun, 2023 | US11684723 |
| Electronic Review Critical | 27 Jun, 2023 | US11684723 |
| Recordation of Patent Grant Mailed Critical | 27 Jun, 2023 | US11684723 |
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
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 Otter Pharmaceuticals Llc. 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 Otter Pharms 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 |
|---|---|---|---|
| 7.5MG/0.4ML (7.5MG/0.4ML) | SOLUTION | Discontinued | SUBCUTANEOUS |
| 10MG/0.4ML (10MG/0.4ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 17.5MG/0.4ML (17.5MG/0.4ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 20MG/0.4ML (20MG/0.4ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 22.5MG/0.4ML (22.5MG/0.4ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 15MG/0.4ML (15MG/0.4ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 25MG/0.4ML (25MG/0.4ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 12.5MG/0.4ML (12.5MG/0.4ML) | SOLUTION | Prescription | SUBCUTANEOUS |