DrugPatentWatch Database Preview
TECFIDERA Drug Profile
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Which patents cover Tecfidera, and what generic alternatives are available?
This drug has sixty-nine patent family members in thirty-three countries.
The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dimethyl fumarate profile page.
Summary for TECFIDERA
| International Patents: | 69 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 81 |
| Clinical Trials: | 51 |
| Patent Applications: | 3,529 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TECFIDERA |
| DailyMed Link: | TECFIDERA at DailyMed |
Medical Subject Heading (MeSH) Categories for TECFIDERA
Synonyms for TECFIDERA
| (E)-but-2-enedioic acid dimethyl ester |
| (E)-Dimethyl fumarate |
| 1,2-bis(methoxycarbonyl)-trans-ethylene |
| 1,4-dimethyl (2E)-but-2-enedioate |
| 1,4-dimethyl but-2-enedioate |
| 2-Butenedioic acid (2E)-, 1,4-dimethyl ester |
| 2-Butenedioic acid (2E)-, dimethyl ester |
| 2-Butenedioic acid (E)-, dimethyl ester |
| 2-Butenedioic acid, 1,4-dimethyl ester |
| 2-Butenedioic acid, dimethyl ester, (2E)- |
| 2-BUTENEDIOIC ACID, DIMETHYL ESTER, (E)- |
| 2(E)-Butenedioic acid 1,4-dimethyl ester |
| 23055-10-9 |
| 4-02-00-02205 (Beilstein Handbook Reference) |
| 624-49-7 |
| AB00172980_03 |
| AB00172980_04 |
| AB2000680 |
| AC1LCUHZ |
| AI3-07872 |
| AJ-45818 |
| AK144835 |
| AK144836 |
| AKOS000121333 |
| Allomaleic acid dimethyl ester |
| AN-22022 |
| AS01220 |
| AZL-0211089 |
| AZL-O-211089 |
| BC226892 |
| BG 00012 |
| BG 12 compound |
| BG-00012 |
| BG-12 |
| BG00012 |
| BIS-METHYL ESTER |
| Boletic acid dimethyl ester |
| BRD-K31111078-001-01-8 |
| BRN 0774590 |
| But-2-enedioic acid, dimethyl ester |
| CCG-213618 |
| CHEBI:76004 |
| CHEMBL2107333 |
| CJ-10800 |
| CS-0909 |
| D03846 |
| D0A7MY |
| DB08908 |
| Dimethyl (2e)-2-butenedioate |
| dimethyl (2E)-but-2-enedioate |
| dimethyl (2E)but-2-ene-1,4-dioate |
| Dimethyl (E)-but-2-enedioate |
| Dimethyl 2-butenedioate |
| Dimethyl fumar |
| Dimethyl fumarate |
| Dimethyl fumarate (JAN/USAN) |
| Dimethyl fumarate, 97% |
| Dimethyl fumarate, 99% 25g |
| Dimethyl fumarate, certified reference material, TraceCERT(R) |
| Dimethyl fumarate, Vetec(TM) reagent grade, 97% |
| Dimethyl trans-ethylenedicarboxylate |
| Dimethylester kyseliny fumarove |
| Dimethylester kyseliny fumarove [Czech] |
| Dimethylfumarate |
| DTXSID4060787 |
| EINECS 210-849-0 |
| Ethylene, 1,2-bis(methoxycarbonyl)-, trans- |
| Ethylene,2-bis(methoxycarbonyl)-, trans- |
| F0001-1675 |
| F0069 |
| FAG 201 |
| FAG-201 |
| FAG201 |
| FO2303MNI2 |
| FR-1080 |
| Fumaderm |
| Fumaric acid dimethyl |
| Fumaric acid dimethyl ester |
| Fumaric acid, dimethyl ester |
| Fumaric acid, dimethyl ester (8CI) |
| GTPL7045 |
| HMS3264D14 |
| HSDB 7725 |
| HY-17363 |
| I14-16593 |
| InChI=1/C6H8O4/c1-9-5(7)3-4-6(8)10-2/h3-4H,1-2H3/b4-3 |
| KB-76619 |
| LDCRTTXIJACKKU-ONEGZZNKSA-N |
| LP050519 |
| LS-46997 |
| Methyl fumarate |
| MFCD00064438 |
| MolPort-001-770-822 |
| MolPort-004-288-380 |
| NE10584 |
| NSC 167432 |
| NSC 25942 |
| NSC-167432 |
| NSC-25942 |
| NSC-760139 |
| NSC167432 |
| NSC25942 |
| NSC760139 |
| OR019934 |
| OR245015 |
| Panaclar |
| Pharmakon1600-01506154 |
| RP20909 |
| RTR-021472 |
| s2586 |
| SBB008222 |
| SC-22552 |
| SCHEMBL41835 |
| SCHEMBL41836 |
| SR-01000944222 |
| SR-01000944222-1 |
| ST2402525 |
| ST50827963 |
| STK039379 |
| Tecfidera (TN) |
| TIMTEC-BB SBB008222 |
| TL 353 |
| TR-021472 |
| trans-1,2-Ethylenedicarboxylic acid dimethyl ester |
| trans-Butenedioic acid dimethyl ester |
| UKRORGSYN-BB BBR-008913 |
| UNII-FO2303MNI2 |
| W-5060 |
| WLN: 1OV1U1VO1 -T |
| ZINC100509880 |
| ZINC3843378 |
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 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 | ➤ Sign Up | ➤ Sign Up |
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for TECFIDERA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-releaseCapsules | 120 mg and 240 mg | ➤ Subscribe | 2017-03-27 |
Non-Orange Book US Patents for TECFIDERA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
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International Patents for TECFIDERA
Supplementary Protection Certificates for TECFIDERA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2014 00055 | Denmark | ➤ Sign Up | PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630 |
| 487 | Luxembourg | ➤ Sign Up | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203 |
| 8 | Finland | ➤ Sign Up | |
| C/GB02/030 | United Kingdom | ➤ Sign Up | PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
