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, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Twi Pharms, Zydus Pharms, and Biogen Inc, and is included in sixteen 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 seventy-seven patent family members in twenty-seven countries.
There are twenty-eight drug master file entries for dimethyl fumarate. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for dimethyl fumarate
| International Patents: | 77 |
| US Patents: | 9 |
| Tradenames: | 2 |
| Applicants: | 16 |
| NDAs: | 16 |
| Drug Master File Entries: | 28 |
| Finished Product Suppliers / Packagers: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 118 |
| Clinical Trials: | 71 |
| Patent Applications: | 5,720 |
| Formulation / Manufacturing: | see details |
| 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
| Applicant | Application No. | Strength | Dosage Form |
| See Plans and Pricing | See Plans and Pricing | 240MG | CAPSULE, DELAYED RELEASE;ORAL |
| See Plans and Pricing | See Plans and Pricing | 120MG | CAPSULE, DELAYED RELEASE;ORAL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Aurobindo Pharma | DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210385-001 | Dec 22, 2022 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | See Plans and Pricing | See Plans and Pricing |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | See Plans and Pricing | See Plans and Pricing |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | See Plans and Pricing | See Plans and Pricing |
| >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 | |
| >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 |
|---|---|---|---|
| European Patent Office | 3220907 | MÉTHODES DE TRAITEMENT DE LA SCLÉROSE EN PLAQUES (METHODS OF TREATING MULTIPLE SCLEROSIS) | See Plans and Pricing |
| Poland | 2653873 | See Plans and Pricing | |
| European Patent Office | 2680007 | Essais de criblage de Nrf2 et procédés et compositions correspondants (Nrf2 screening assays and related methods and compositions) | See Plans and Pricing |
| Denmark | 2629097 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dimethyl fumarate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2137537 | C300674 | Netherlands | See Plans and Pricing | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 0284288 | SPC/GB98/002 | United Kingdom | See Plans and Pricing | PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730 |
| 2137537 | 1490038-5 | Sweden | See Plans and Pricing | PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203 |
| 2137537 | 122014000069 | Germany | See Plans and Pricing | PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
