Methotrexate Patent Expiration
Methotrexate is Used for treating conditions such as cancer, rheumatoid arthritis, and certain types of psoriasis. It was first introduced by Cosette Pharmaceuticals Inc
Methotrexate Patents
Given below is the list of patents protecting Methotrexate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Jylamvo | US11129833 | Methotrexate formulation | Oct 28, 2035 | Shorla |
| Jylamvo | US12605385 | Methotrexate Formulation | Oct 25, 2035 | Shorla |
| Jylamvo | US11771701 | Methotrexate formulation | Oct 29, 2034 | Shorla |
| Otrexup | US8814834 | Injector safety device | May 27, 2031 | Cosette |
| Otrexup | US11497753 | Hazardous agent injection system | Mar 19, 2030 | Cosette |
| Otrexup | US12357642 | Hazardous Agent Injection System | Mar 19, 2030 | Cosette |
| Otrexup | US8480631 | Hazardous agent injection system | Mar 19, 2030 | Cosette |
| Otrexup | US8579865 | Hazardous agent injection system | Mar 19, 2030 | Cosette |
| Otrexup | US8945063 | Hazardous agent injection system | Mar 19, 2030 | Cosette |
| Otrexup | US9421333 | Hazardous agent injection system | Mar 19, 2030 | Cosette |
| Rasuvo | US8664231 | Concentrated methotrexate solutions | Jun 01, 2029 | Medexus |
| Otrexup | US10709844 | Injector safety device | Mar 10, 2029 | Cosette |
| Otrexup | US11684723 | Injector safety device | Mar 10, 2029 | Cosette |
| Otrexup | US9867949 | Injector safety device | Mar 10, 2029 | Cosette |
| Otrexup | US8021335 | Prefilled syringe jet injector |
Oct 04, 2026
(Expired) | Cosette |
| Otrexup | US11446441 | Prefilled syringe injector |
Jan 24, 2026
(Expired) | Cosette |
| Otrexup | US8562564 | Prefilled syringe jet injector |
Jan 24, 2026
(Expired) | Cosette |
| Otrexup | US9533102 | Prefilled syringe jet injector |
Jan 24, 2026
(Expired) | Cosette |
| Otrexup | US9629959 | Prefilled syringe jet injector |
Jan 24, 2026
(Expired) | Cosette |
| Otrexup | US6746429 | Needle assisted jet injector |
Apr 12, 2020
(Expired) | Cosette |
| Otrexup | US7744582 | Needle assisted jet injector |
Aug 10, 2019
(Expired) | Cosette |
| Otrexup | US7776015 | Needle assisted jet injector |
Aug 10, 2019
(Expired) | Cosette |
| Otrexup | USRE44846 | Needle assisted jet injector |
Aug 10, 2019
(Expired) | Cosette |
| Otrexup | USRE44847 | Needle assisted jet injector |
Aug 10, 2019
(Expired) | Cosette |
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 Methotrexate's patents.
Latest Legal Activities on Methotrexate's Patents
Given below is the list recent legal activities going on the following patents of Methotrexate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Aug, 2025 | US8664231(Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Aug, 2021 | US8664231(Litigated) |
| Review Certificate Mailed | 03 Sep, 2019 | US8664231(Litigated) |
| Review Certificate | 13 Aug, 2019 | US8664231(Litigated) |
| Termination or Final Written Decision | 07 Feb, 2018 | US8664231(Litigated) |
| Request for Trial Granted Critical
| 08 Feb, 2017 | US8664231(Litigated) |
| Termination or Final Written Decision | 08 Dec, 2016 | US8664231(Litigated) |
| Request for Trial Granted in Part | 01 Sep, 2016 | US8664231(Litigated) |
| Petition Requesting Trial | 20 Jul, 2016 | US8664231(Litigated) |
| Petition Requesting Trial | 22 Feb, 2016 | US8664231(Litigated) |
Methotrexate's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Methotrexate:
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.
