Details for New Drug Application (NDA): 211855
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NDA 211855 describes VUMERITY, which is a drug marketed by Biogen Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the VUMERITY profile page.
The generic ingredient in VUMERITY is diroximel fumarate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the diroximel fumarate profile page.
The generic ingredient in VUMERITY is diroximel fumarate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the diroximel fumarate profile page.
Summary for 211855
| Tradename: | VUMERITY |
| Applicant: | Biogen Inc |
| Ingredient: | diroximel fumarate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211855
Generic Entry Date for 211855*:
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: 211855
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VUMERITY | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 211855 | NDA | Biogen Inc. | 64406-020 | 64406-020-01 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-01) / 106 CAPSULE in 1 BOTTLE, PLASTIC |
| VUMERITY | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 211855 | NDA | Biogen Inc. | 64406-020 | 64406-020-03 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-03) / 120 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 231MG | ||||
| Approval Date: | Oct 29, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 20, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING MULTIPLE SCLEROSIS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 20, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 20, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING MULTIPLE SCLEROSIS | ||||||||
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