Dimethyl fumarate - Generic Drug Details
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What are the generic drug sources for dimethyl fumarate and what is the scope of patent protection?
Dimethyl fumarate
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Twi Pharms, Zydus Pharms, and Biogen Inc, and is included in seventeen NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Dimethyl fumarate has eighty-eight patent family members in twenty-nine countries.
There are twenty-eight drug master file entries for dimethyl fumarate. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for dimethyl fumarate
| International Patents: | 88 |
| US Patents: | 9 |
| Tradenames: | 2 |
| Applicants: | 17 |
| NDAs: | 17 |
| Drug Master File Entries: | 28 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 129 |
| Clinical Trials: | 71 |
| Patent Applications: | 5,478 |
| Drug Prices: | Drug price trends for dimethyl fumarate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dimethyl fumarate |
| What excipients (inactive ingredients) are in dimethyl fumarate? | dimethyl fumarate excipients list |
| DailyMed Link: | dimethyl fumarate at DailyMed |
Recent Clinical Trials for dimethyl fumarate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Imcyse SA | Phase 1/Phase 2 |
| Assistance Publique - Hôpitaux de Paris | Phase 2 |
| Xuanwu Hospital, Beijing | Phase 2 |
Generic filers with tentative approvals for DIMETHYL FUMARATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Medical Subject Heading (MeSH) Categories for dimethyl fumarate
Anatomical Therapeutic Chemical (ATC) Classes for dimethyl fumarate
Paragraph IV (Patent) Challenges for DIMETHYL FUMARATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TECFIDERA | Delayed-release Capsules | dimethyl fumarate | 120 mg and 240 mg | 204063 | 29 | 2017-03-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hetero Labs Ltd Iii | DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210500-001 | Sep 24, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin | DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210226-001 | Oct 5, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Prinston Inc | DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210414-002 | Oct 18, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Pharms Ltd | DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210309-001 | Oct 6, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sawai Usa | DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210285-002 | Dec 21, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | 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 dimethyl fumarate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Biogen 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 |
EU/EMA Drug Approvals for dimethyl fumarate
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Almirall S.A | Skilarence | dimethyl fumarate | EMEA/H/C/002157 Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. |
Authorised | no | no | no | 2017-06-23 | |
| Biogen Netherlands B.V. | Tecfidera | dimethyl fumarate | EMEA/H/C/002601 Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). |
Authorised | no | no | no | 2014-01-30 | |
| Mylan Ireland Limited | Dimethyl fumarate Mylan | dimethyl fumarate | EMEA/H/C/005956 Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis. |
Authorised | yes | no | no | 2022-05-13 | |
| Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. | Dimethyl fumarate Polpharma | dimethyl fumarate | EMEA/H/C/005955 Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis. |
Authorised | yes | no | no | 2022-05-13 | |
| Laboratorios Lesvi S.L. | Dimethyl fumarate Neuraxpharm | dimethyl fumarate | EMEA/H/C/006039 Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis. |
Authorised | yes | no | no | 2022-05-13 | |
| Teva GmbH | Dimethyl fumarate Teva | dimethyl fumarate | EMEA/H/C/005963 Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). |
Authorised | yes | no | no | 2022-12-12 | |
| Accord Healthcare S.L.U. | Dimethyl fumarate Accord | dimethyl fumarate | EMEA/H/C/005950 Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). |
Authorised | yes | no | no | 2023-02-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for dimethyl fumarate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2016081355 | ⤷ Sign Up | |
| Slovenia | 2653873 | ⤷ Sign Up | |
| France | 14C0050 | ⤷ Sign Up | |
| Morocco | 53882 | MÉTHODES DE TRAITEMENT DE LA SCLÉROSE EN PLAQUES | ⤷ Sign Up |
| Portugal | 2137537 | ⤷ Sign Up | |
| Lithuania | 2653873 | ⤷ Sign Up | |
| Poland | 2653873 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dimethyl fumarate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0230742 | 2001C/040 | Belgium | ⤷ Sign Up | PRODUCT NAME: MONOHYDRATE DU CHLORHYDRATE DE N,N-DIMETHYL-1-4-CHLOROPHENYL)CYCLOBUTYL-3-METHYLBUTYLAMINE ET COMPOSITIONS PHARMACEUTIQUES LE CONTENANT; NAT. REGISTRTION NO/DATE: 479 IS 52 F 5 20010425; FIRST REGISTRATION: CH 54770 19990113 |
| 1761528 | CA 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 |
| 2137537 | 132014902274513 | Italy | ⤷ Sign Up | PRODUCT NAME: DIMETILFUMARATO(TECFIDERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/837/001-002, 20140203 |
| 0605697 | SPC/GB01/008 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026 |
| 2137537 | 300674 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 2137537 | CA 2014 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130 |
| 0300652 | SPC/GB03/005 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: D-MEDETOMIDINE (4-((1S)-1-(2,3-DIMETHYLPHENYL)ETHYL)-1H-IMIDAZOLE) AND ITS NON-TOXIC PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE HYDROCHLORIDE; REGISTERED: UK EU/2/02/033/001 20020830 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
