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Monomethyl fumarate - Generic Drug Details
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What are the generic drug sources for monomethyl fumarate and what is the scope of patent protection?
Monomethyl fumarate
is the generic ingredient in one branded drug marketed by Banner Life Sciences and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Monomethyl fumarate has seventeen patent family members in seven countries.
There are two drug master file entries for monomethyl fumarate. One supplier is listed for this compound.
Summary for monomethyl fumarate
| International Patents: | 17 |
| US Patents: | 15 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 6 |
| Patent Applications: | 22 |
| DailyMed Link: | monomethyl fumarate at DailyMed |
Recent Clinical Trials for monomethyl fumarate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Banner Life Sciences LLC | Phase 1 |
| Almirall, S.A. | Phase 1 |
| Multiple Sclerosis Center of Northeastern New York | Phase 4 |
US Patents and Regulatory Information for monomethyl fumarate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for monomethyl fumarate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3110408 | Start Trial |
| Denmark | 3110408 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2015130998 | Start Trial |
| Australia | 2015328676 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2017040272 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
