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Dimethyl fumarate - Generic Drug Details
What are the generic drug sources for dimethyl fumarate and what is the scope of dimethyl fumarate patent protection?
Dimethyl fumarate
is the generic ingredient in one branded drug marketed by Biogen Idec Inc and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are seventy-six drug master file entries for dimethyl fumarate. One supplier is listed for this compound.
Summary for dimethyl fumarate
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 76 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 82 |
| Clinical Trials: | 57 |
| Patent Applications: | 5,362 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dimethyl fumarate |
| DailyMed Link: | dimethyl fumarate at DailyMed |
Medical Subject Heading (MeSH) Categories for dimethyl fumarate
Synonyms for dimethyl fumarate
| (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 (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 |
| 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 dimethyl fumarate
| 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 | 204063-002 | 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 | |||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | RX | Yes | No | ➤ 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 dimethyl fumarate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
International Patents for dimethyl fumarate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2012255020 | ➤ Sign Up |
| Estonia | 200100266 | ➤ Sign Up |
| Israel | 142728 | ➤ Sign Up |
| Australia | 752733 | ➤ Sign Up |
| Slovenia | 1131065 | ➤ Sign Up |
| China | 1182844 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for dimethyl fumarate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 8 | Finland | ➤ Sign Up | |
| 90039-3 | Sweden | ➤ Sign Up | PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130 |
| 00675 | Netherlands | ➤ Sign Up | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 2014024 | Lithuania | ➤ Sign Up | PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 2014023 | Lithuania | ➤ Sign Up | PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 2010 00036 | Denmark | ➤ Sign Up | PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
