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 twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.Monomethyl fumarate has twenty 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: | 20 |
| US Patents: | 21 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 10 |
| Patent Applications: | 5,215 |
| What excipients (inactive ingredients) are in monomethyl fumarate? | monomethyl fumarate excipients list |
| DailyMed Link: | monomethyl fumarate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for monomethyl fumarate
Generic Entry Date for monomethyl fumarate*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, DELAYED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for monomethyl fumarate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Biogen | Phase 3 |
| Banner Life Sciences LLC | Phase 1 |
| Almirall, S.A. | Phase 1 |
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 | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Banner Life Sciences | BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296-001 | Apr 28, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| >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 | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2016253548 | Controlled release enteric soft capsules of fumarate esters | ⤷ Subscribe |
| Denmark | 3110408 | ⤷ Subscribe | |
| European Patent Office | 3110408 | CAPSULES MOLLES ENTÉRIQUES À LIBÉRATION CONTRÔLÉE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
