Rasuvo is a drug owned by Medexus Pharma Inc. It is protected by 1 US drug patent filed in 2014 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 01, 2029. Details of Rasuvo'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). | |||
| US8664231 | Concentrated methotrexate solutions |
Jun, 2029
(2 years from now) | Active |
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 Rasuvo's patents.
Latest Legal Activities on Rasuvo's Patents
Given below is the list of recent legal activities going on the following patents of Rasuvo.
| 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) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Rasuvo and ongoing
litigations to
help you estimate the early arrival of Rasuvo generic.
Rasuvo's Litigations
Rasuvo been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 01, 2014, against patent number US8664231. The petitioner Antares Pharma, Inc., challenged the validity of this patent, with Medac Gesellschaft Fur Klinische as the respondent. Click below to track the latest information on how companies are challenging Rasuvo's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8664231 | July, 2016 |
Final Written Decision
(07 Feb, 2018) | MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH et al. | Koios Pharmaceuticals LLC |
| US8664231 | February, 2016 |
Terminated-Settled
(08 Dec, 2016) | MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH | Frontier Therapeutics, LLC |
| US8664231 | July, 2014 |
Terminated-Settled
(30 Apr, 2015) | Medac Gesellschaft Fur Klinische | Antares Pharma, Inc. |
Several oppositions have been filed on Rasuvo'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 Rasuvo's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Rasuvo patents.
Rasuvo's Oppositions Filed in EPO
Rasuvo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 15, 2011, by Antares Pharma, Inc.. This opposition was filed on patent number EP07786239A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP07786239A | Oct, 2012 | Actavis Group ehf | Opposition rejected |
| EP07786239A | Sep, 2011 | Antares Pharma, Inc. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but
Rasuvo 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 Rasuvo's family patents as well as insights into
ongoing legal events
on those patents.
Rasuvo's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Rasuvo:
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:
Rasuvo's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 01, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rasuvo Generics:
There are no approved generic versions for Rasuvo as of now.
Alternative Brands for Rasuvo
Rasuvo which is used for treating autoimmune conditions such as rheumatoid arthritis and 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 | ||
|---|---|---|---|---|
| Cosette |
| |||
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 Rasuvo
Rasuvo is a drug owned by Medexus Pharma Inc. It is used for treating autoimmune conditions such as rheumatoid arthritis and psoriasis. Rasuvo uses Methotrexate as an active ingredient. Rasuvo was launched by Medexus in 2014.
Approval Date:
Rasuvo was approved by FDA for market use on 10 July, 2014.
Active Ingredient:
Rasuvo uses Methotrexate as the active ingredient. Check out other Drugs and Companies using Methotrexate ingredient
Treatment:
Rasuvo is used for treating autoimmune conditions such as rheumatoid arthritis and psoriasis.
Dosage:
Rasuvo is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 22.5MG/0.45ML (22.5MG/0.45ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 7.5MG/0.15ML (7.5MG/0.15ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 15MG/0.30ML (15MG/0.30ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 17.5MG/0.35ML (17.5MG/0.35ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 25MG/0.5ML (25MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 30MG/0.6ML (30MG/0.6ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 10MG/0.20ML (10MG/0.20ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 20MG/0.4ML (20MG/0.4ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 12.5MG/0.25ML (12.5MG/0.25ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 27.5MG/0.55ML (27.5MG/0.55ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | SUBCUTANEOUS |