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OTREXUP Drug Profile
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Which patents cover Otrexup, and when can generic versions of Otrexup launch?
Otrexup is a drug marketed by Antares Pharma Inc and is included in one NDA. There are twelve patents protecting this drug.
This drug has forty-eight patent family members in fifteen countries.
The generic ingredient in OTREXUP is methotrexate. There are twenty drug master file entries for this compound. Additional details are available on the methotrexate profile page.
US ANDA Litigation and Generic Entry Outlook for Otrexup
There have been two 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
Summary for OTREXUP
| International Patents: | 48 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 132 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,005 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OTREXUP |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OTREXUP |
| DailyMed Link: | OTREXUP at DailyMed |
Recent Clinical Trials for OTREXUP
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Wisconsin, Madison | Phase 1 |
| University of Virginia | Phase 1 |
| Vanderbilt University | Phase 1 |
US Patents and Regulatory Information for OTREXUP
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Antares Pharma Inc | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-003 | Oct 11, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Antares Pharma Inc | OTREXUP PFS | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-013 | May 31, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Antares Pharma Inc | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Antares Pharma Inc | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | Start Trial | Start Trial |
| Antares Pharma Inc | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | Start Trial | Start Trial |
| Antares Pharma Inc | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-004 | Oct 11, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OTREXUP
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69921704 | Start Trial |
| Australia | 2010226442 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0009186 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
