Details for New Drug Application (NDA): 204063
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
NDA 204063 describes TECFIDERA, which is a drug marketed by Biogen Inc and is included in one NDA. It is available from two suppliers. 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 are seventy-six drug master file entries for this compound. Nineteen 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 are seventy-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
Summary for 204063
| Tradename: | TECFIDERA |
| Applicant: | Biogen Inc |
| Ingredient: | dimethyl fumarate |
| Patents: | 9 |
| Formulation / Manufacturing: | see details |
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 AUTHORIZED GENERIC | TEVA PHARMACEUTICALS USA, INC. | 0093-9219 | 0093-9219-06 | 1 BOTTLE, PLASTIC in 1 CARTON (0093-9219-06) / 60 CAPSULE in 1 BOTTLE, PLASTIC |
| 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 |
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 | ||||
| Regulatory Exclusivity Expiration: | Feb 5, 2023 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS | ||||||||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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 | ||||||||
Expired US Patents for NDA 204063
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
