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TECFIDERA Drug Profile
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» See Plans and PricingWhen 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. One supplier is listed for this compound. Additional details are available on the dimethyl fumarate profile page.
US ANDA Litigation and Generic Entry Outlook for Tecfidera
Tecfidera was eligible for patent challenges on March 27, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 20, 2020. This may change due to patent challenges or generic licensing.
There have been thirty-six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are six tentative approvals for the generic drug (dimethyl fumarate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for TECFIDERA
| International Patents: | 69 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 94 |
| Clinical Trials: | 55 |
| Patent Applications: | 4,031 |
| 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
Generic Entry Date for TECFIDERA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, DELAYED RELEASE;ORAL |
*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.
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 |
Recent Litigation for TECFIDERA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Biogen International GmbH v. Cipla Limited | 2019-11-27 |
| BIOGEN INTERNATIONAL GMBH v. ZYDUS PHARMACEUTICALS (USA) INC. | 2019-02-15 |
| Biogen International GmbH v. Banner Life Sciences LLC | 2018-12-27 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Sawai USA, Inc. | 2019-03-05 |
| 2018-07-13 | |
| Coalition For Affordable Drugs V LLC | 2015-09-28 |
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 |
| AI3-07872 |
| AK144836 |
| AKOS000121333 |
| Allomaleic acid dimethyl ester |
| AS01220 |
| AZL O 211089 |
| AZL-0211089 |
| AZL-O-211089 |
| BG 00012 |
| BG 12 |
| 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 |
| 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-butenedioate |
| Dimethyl trans-ethylenedicarboxylate |
| dimethyl-fumarate |
| 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 |
| FP-187 |
| FP187 |
| Fumaderm |
| Fumaric acid dimethyl |
| Fumaric acid dimethyl ester |
| Fumaric acid dimethyl ester 100 microg/mL in Methanol |
| Fumaric acid-dimethyl ester |
| Fumaric acid, dimethyl ester |
| GTPL7045 |
| HMS3264D14 |
| HSDB 7725 |
| HY-17363 |
| InChI=1/C6H8O4/c1-9-5(7)3-4-6(8)10-2/h3-4H,1-2H3/b4-3 |
| LDCRTTXIJACKKU-ONEGZZNKSA-N |
| LS-46997 |
| Methyl fumarate |
| MFCD00064438 |
| NE10584 |
| NSC 167432 |
| NSC 25942 |
| NSC-167432 |
| NSC-25942 |
| NSC-760139 |
| NSC167432 |
| NSC25942 |
| NSC760139 |
| Panaclar |
| Pharmakon1600-01506154 |
| Q418123 |
| 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 |
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 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Biogen Idec Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | RX | Yes | Yes | 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 | 204063-002 | 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 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TECFIDERA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2680008 | Start Trial |
| Denmark | 1131065 | Start Trial |
| European Patent Office | 2680006 | Start Trial |
| Poland | 226074 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TECFIDERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2137537 | 92487 | Luxembourg | Start Trial | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203 |
| 2137537 | 1490038-5 | Sweden | Start Trial | PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203 |
| 1131065 | C300675 | Netherlands | Start Trial | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 2137537 | 132014902274513 | Italy | Start Trial | PRODUCT NAME: DIMETILFUMARATO(TECFIDERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/837/001-002, 20140203 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
