DrugPatentWatch Database Preview
TECFIDERA Drug Profile
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 seven patents protecting this drug and one Paragraph IV challenge.
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
Generic Entry Opportunity Date for TECFIDERA
*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.
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 | ||||
| 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 | ||||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 | ➤ Sign Up | ➤ Sign Up |
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | 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 |
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | 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 | Date |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-releaseCapsules | 120 mg and 240 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for TECFIDERA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hungary | 0103182 | ➤ Sign Up |
| Hungary | 226689 | ➤ Sign Up |
| Serbia | 52922 | ➤ Sign Up |
| Bulgaria | 64837 | ➤ Sign Up |
| Hong Kong | 1042242 | ➤ Sign Up |
| Germany | 59905954 | ➤ Sign Up |
| Australia | 752733 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for TECFIDERA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2014023 | Lithuania | ➤ Sign Up | PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 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 |
| 00675 | Netherlands | ➤ Sign Up | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 8 | Finland | ➤ Sign Up | |
| /2014 | Austria | ➤ Sign Up | PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 487 | Luxembourg | ➤ Sign Up | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203 |
| 2014 00035 | Denmark | ➤ Sign Up | PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
