DrugPatentWatch Database Preview
TECFIDERA Drug Profile
Which patents cover Tecfidera, 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.
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: | 90 |
| Clinical Trials: | 52 |
| Patent Applications: | 3,625 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TECFIDERA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TECFIDERA |
| DailyMed Link: | TECFIDERA at DailyMed |
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 |
| 1017900-75-2 |
| 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 |
| AK144836 |
| AKOS000121333 |
| Allomaleic acid dimethyl ester |
| AN-22022 |
| AS01220 |
| AZL O 211089 |
| AZL-0211089 |
| AZL-O-211089 |
| BC226892 |
| BCP21649 |
| BG 00012 |
| BG 12 [Fumarate] |
| BG 12 compound |
| BG-00012 |
| BG-12 |
| BG-12 [Fumarate] |
| 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 |
| 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 [USAN] |
| Dimethyl fumarate, 97% |
| Dimethyl fumarate, 99% |
| 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 |
| 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 |
| 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 |
| Panaclar |
| Pharmakon1600-01506154 |
| RP20909 |
| RTR-021472 |
| s2586 |
| SBB008222 |
| SC-22552 |
| SCHEMBL41835 |
| SCHEMBL41836 |
| SR-01000944222 |
| SR-01000944222-1 |
| ST2402525 |
| ST50827963 |
| STK039379 |
| SW219154-1 |
| 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 | 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 | 204063-001 | 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 |
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 | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 510247 | ➤ Sign Up |
| Portugal | 2137537 | ➤ Sign Up |
| South Africa | 200202335 | ➤ Sign Up |
| Montenegro | 00731 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for TECFIDERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2137537 | PA2014024 | Lithuania | ➤ Sign Up | PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 1131065 | 518 | Finland | ➤ Sign Up | |
| 1131065 | 92488 | Luxembourg | ➤ Sign Up | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130 |
| 2137537 | CA 2014 00035 | Denmark | ➤ Sign Up | PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
