Details for New Drug Application (NDA): 204063
NDA 204063 describes TECFIDERA, which is a drug marketed by Biogen and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TECFIDERA profile page.
The generic ingredient in TECFIDERA is dimethyl fumarate. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
The generic ingredient in TECFIDERA is dimethyl fumarate. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
Summary for 204063
| Tradename: | TECFIDERA |
| Applicant: | Biogen |
| Ingredient: | dimethyl fumarate |
| Patents: | 9 |
Medical Subject Heading (MeSH) Categories for 204063
Suppliers and Packaging for NDA: 204063
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063 | NDA | Biogen Inc. | 64406-005 | 64406-005-01 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) / 14 CAPSULE in 1 BOTTLE, PLASTIC |
| TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063 | NDA | Biogen Inc. | 64406-006 | 64406-006-02 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-006-02) / 60 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Mar 27, 2013 | TE: | AB | RLD: | Yes | ||||
| Patent: | 10,391,160 | Patent Expiration: | Mar 13, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE | ||||||||
| Patent: | 10,555,993 | Patent Expiration: | Mar 13, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE | ||||||||
| Patent: | 10,959,972 | Patent Expiration: | Nov 16, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING MULTIPLE SCLEROSIS | ||||||||
Expired US Patents for NDA 204063
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Biogen | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | 7,320,999 | ⤷ Start Trial |
| Biogen | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | 8,759,393 | ⤷ Start Trial |
| Biogen | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | 6,509,376 | ⤷ Start Trial |
| Biogen | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | 7,803,840 | ⤷ Start Trial |
| Biogen | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | 7,619,001 | ⤷ Start Trial |
| Biogen | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | 8,759,393 | ⤷ Start Trial |
| Biogen | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | 7,619,001 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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