Details for New Drug Application (NDA): 210296
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NDA 210296 describes BAFIERTAM, which is a drug marketed by Banner Life Sciences and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting this drug. Additional details are available on the BAFIERTAM profile page.
The generic ingredient in BAFIERTAM is monomethyl fumarate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the monomethyl fumarate profile page.
The generic ingredient in BAFIERTAM is monomethyl fumarate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the monomethyl fumarate profile page.
Summary for 210296
| Tradename: | BAFIERTAM |
| Applicant: | Banner Life Sciences |
| Ingredient: | monomethyl fumarate |
| Patents: | 21 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210296
Generic Entry Date for 210296*:
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.
Suppliers and Packaging for NDA: 210296
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BAFIERTAM | monomethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210296 | NDA | Banner Life Sciences LLC | 69387-001 | 69387-001-01 | 120 CAPSULE in 1 BOTTLE (69387-001-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 95MG | ||||
| Approval Date: | Apr 28, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 27, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING MULTIPLE SCLEROSIS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 27, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 27, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING MULTIPLE SCLEROSIS | ||||||||
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