TECFIDERA Drug Patent Profile
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When do Tecfidera patents expire, and what generic alternatives are available?
Tecfidera is a drug marketed by Biogen Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-one patent family members in twenty-eight countries.
The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tecfidera
A generic version of TECFIDERA was approved as dimethyl fumarate by MYLAN on August 17th, 2020.
Summary for TECFIDERA
| International Patents: | 81 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 57 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TECFIDERA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TECFIDERA |
| What excipients (inactive ingredients) are in TECFIDERA? | TECFIDERA excipients list |
| DailyMed Link: | TECFIDERA at DailyMed |
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 |
| Fondation Ophtalmologique Adolphe de Rothschild | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for TECFIDERA
Paragraph IV (Patent) Challenges for TECFIDERA
| 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 TECFIDERA
TECFIDERA is protected by nine US patents and one FDA Regulatory Exclusivity.
Patents protecting TECFIDERA
Dimethyl fumarate and vaccination regimens
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Dimethyl fumarate and vaccination regimens
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Dimethyl fumarate and vaccination regimens
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Treatment for multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
FDA Regulatory Exclusivity protecting TECFIDERA
INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-001 | Mar 27, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TECFIDERA
| 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 TECFIDERA
See the table below for patents covering TECFIDERA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 2629097 | ⤷ Try a Trial | |
| Finland | 2629097 | ⤷ Try a Trial | |
| Japan | 2002530324 | ⤷ Try a Trial | |
| Hungary | 226689 | USE OF DIALKYLFUMARATES FOR PRODUCING PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT AUTOIMMUNE DISEASES | ⤷ Try a Trial |
| Lithuania | PA2023503 | ⤷ Try a Trial | |
| South Korea | 20210111362 | 다발성 경화증을 치료하는 방법 (METHODS OF TREATING MULTIPLE SCLEROSIS) | ⤷ Try a Trial |
| Eurasian Patent Organization | 202191097 | СПОСОБЫ ЛЕЧЕНИЯ РАССЕЯННОГО СКЛЕРОЗА | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TECFIDERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0693475 | CR 2010 00036 | Denmark | ⤷ Try a Trial | 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 |
| 2137537 | 92487 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203 |
| 1131065 | 92488 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130 |
| 2137537 | SPC/GB14/046 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DIMETHYL FUMARATE; REGISTERED: UK EU/1/13/837 20140203 |
| 2653873 | 122023000006 | Germany | ⤷ Try a Trial | PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837 20140130 |
| 2653873 | PA2023503 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DIMETILFUMARATAS; REGISTRATION NO/DATE: EU/1/13/837 20140130 |
| 1761528 | CA 2014 00055 | Denmark | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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