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 fifty-seven patent family members in twenty-three countries.
The generic ingredient in TECFIDERA is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Seventeen 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: | 57 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 56 |
| 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Dimethyl fumarate and vaccination regimens
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Dimethyl fumarate and vaccination regimens
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Methods of treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Treatment for multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | 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 | |||
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063-002 | Mar 27, 2013 | AB | RX | Yes | Yes | 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 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 | 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 | 204063-001 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TECFIDERA
See the table below for patents covering TECFIDERA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Morocco | 39743 | FUMARATE DE DIMÉTHYLE ET RÉGIMES DE VACCINATION (DIMETHYL FUMARATE AND VACCINATION REGIMENS) | See Plans and Pricing |
| European Patent Office | 3804711 | MÉTHODES DE TRAITEMENT DE LA SCLÉROSE EN PLAQUES (METHODS OF TREATING MULTIPLE SCLEROSIS) | See Plans and Pricing |
| Norway | 20121479 | See Plans and Pricing | |
| Mexico | 2017006473 | METODOS PARA TRATAR LA ESCLEROSIS MULTIPLE. (METHODS OF TREATING MULTIPLE SCLEROSIS.) | See Plans and Pricing |
| Japan | 2017537089 | 多発性硬化症の治療方法 | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TECFIDERA
| 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 |
| 0526708 | SPC/GB02/030 | United Kingdom | See Plans and Pricing | PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS |
| 1761528 | CR 2014 00055 | Denmark | See Plans and Pricing | 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 20140702 |
| 1131065 | 92488 | Luxembourg | See Plans and Pricing | PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130 |
| 2137537 | 1490038-5 | Sweden | See Plans and Pricing | PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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