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TECFIDERA Drug Profile
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When do Tecfidera patents expire, and what generic alternatives are available?
Tecfidera is a drug marketed by Biogen Idec Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-nine patent family members in thirty-two countries.
The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tecfidera
A generic version of TECFIDERA was approved as dimethyl fumarate by MYLAN on August 17th, 2020.
Summary for TECFIDERA
| International Patents: | 69 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 108 |
| Clinical Trials: | 56 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TECFIDERA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TECFIDERA |
| What excipients (inactive ingredients) are in TECFIDERA? | TECFIDERA excipients list |
| DailyMed Link: | TECFIDERA at DailyMed |
Recent Clinical Trials for TECFIDERA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Phase 2 |
| Banner Life Sciences LLC | Phase 1 |
| Universita degli Studi di Genova | Phase 4 |
Paragraph IV (Patent) Challenges for TECFIDERA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TECFIDERA | CAPSULE, DELAYED RELEASE;ORAL | dimethyl fumarate | 204063 | 2017-03-27 |
US Patents and Regulatory Information for TECFIDERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for TECFIDERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | Start Trial | Start Trial |
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | Start Trial | Start Trial |
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TECFIDERA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2137537 | Start Trial |
| Denmark | 2137537 | Start Trial |
| European Patent Office | 2680007 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TECFIDERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2137537 | SPC/GB14/046 | United Kingdom | Start Trial | PRODUCT NAME: DIMETHYL FUMARATE; REGISTERED: UK EU/1/13/837 20140203 |
| 2137537 | 92487 | Luxembourg | Start Trial | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203 |
| 1131065 | 92488 | Luxembourg | Start Trial | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
