FDA application holder
Biogen Inc
The Orange Book identifies this organization as the applicant responsible for NDA 204063.
Orange Book drug · Brand (NDA)
Tecfidera
Dimethyl Fumarate
RLDNDA 204063 2 strengths Biogen
Approved
Mar 27, 2013
Strengths
2
Listed patents
9
What does the FDA Orange Book show for Tecfidera?
Tecfidera contains Dimethyl Fumarate and is the new drug FDA Orange Book record for NDA 204063. The application has 2 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.
- FDA application
- NDA 204063
- Application holder
- Biogen Inc
- Product presentations
- 2
- Marketing categories
- Prescription
- Reference roles
- RLD / RS
- TE codes
- AB
- Listed patents
- 9
- Exclusivity records
- 0
New drug application identity from the Orange Book snapshot.
The listed applicant holds the FDA application; this field does not establish the product manufacturer.
Each FDA product number remains tied to its own strength, dosage form, route, and status.
Orange Book marketing categories do not establish real-time inventory or commercial availability.
RLD and RS designations are presentation-specific, not inferred from the trade name.
Therapeutic-equivalence codes apply only within the matching Orange Book product heading.
A zero means none appear in this snapshot, not that no patent rights exist.
FDA exclusivity and listed patent protection are distinct regulatory concepts.
Sourced from the official FDA Orange Book data file · snapshot refreshed
FDA product-presentation matrix
Every product number in this exact application
| Product | Strength | Dosage form / route | Marketing status | TE code | Reference role |
|---|---|---|---|---|---|
| 001 | 120MG | CAPSULE, DELAYED RELEASEORAL | Prescription | AB | RLD |
| 002 | 240MG | CAPSULE, DELAYED RELEASEORAL | Prescription | AB | RLDRS |
Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.
Who is responsible for this application?
Application holder is not the same as manufacturer
Manufacturer status
Not established by the Orange Book
A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.
Regulatory interpretation
What the record means, and what it does not
FDA marketing status
2 presentations listed as prescription
RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.
Therapeutic equivalence
TE code AB across rated presentations
An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.
Patent & exclusivity record
9 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026
The latest future date recorded across those files is Nov 16, 2035. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.
Same-ingredient landscape
17 other ANDAs and 0 other NDAs found
12 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.
Which products are meaningfully comparable?
Exact ingredient + dosage form + route cohorts
NDA 204063 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Capsule, Delayed Release · Oral
Dimethyl Fumarate
- Product rows
- 36
- Active applications
- 13
- Active with AB row
- 13
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-204063
No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.
Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.
Strengths & dosage forms
2 approved presentations · NDA 204063
TE ABRLD
- Strength
- 120MG
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
13 yr 6 mo ago
Today
Patent 8399514 expires
Listed method-of-use patent (U-1384) expiration.
in 1 yr 7 mo
Patent 10391160 expires
Listed method-of-use patent (U-3148) expiration.
in 8 yr 9 mo
Patent 10555993 expires
Listed method-of-use patent (U-3148) expiration.
in 8 yr 9 mo
Patent 10994003 expires
Listed method-of-use patent (U-3148) expiration.
in 8 yr 9 mo
Patent 10959972 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent 11007166 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent 11007167 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent 11129806 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent 11246850 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
DIMETHYL FUMARATE
Strength
120MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 204063
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 8399514 | in 1 yr 7 mo | U-1384 | |
| 10391160 | in 8 yr 9 mo | U-3148 | |
| 10555993 | in 8 yr 9 mo | U-3148 | |
| 10994003 | in 8 yr 9 mo | U-3148 | |
| 10959972 | in 9 yr 5 mo | U-1384 | |
| 11007166 | in 9 yr 5 mo | U-1384 | |
| 11007167 | in 9 yr 5 mo | U-1384 | |
| 11129806 | in 9 yr 5 mo | U-1384 | |
| 11246850 | in 9 yr 5 mo | U-1384 |
TE ABRLDRS
- Strength
- 240MG
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
13 yr 6 mo ago
Today
Patent 8399514 expires
Listed method-of-use patent (U-1384) expiration.
in 1 yr 7 mo
Patent 10391160 expires
Listed method-of-use patent (U-3148) expiration.
in 8 yr 9 mo
Patent 10555993 expires
Listed method-of-use patent (U-3148) expiration.
in 8 yr 9 mo
Patent 10994003 expires
Listed method-of-use patent (U-3148) expiration.
in 8 yr 9 mo
Patent 10959972 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent 11007166 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent 11007167 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent 11129806 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent 11246850 expires
Listed method-of-use patent (U-1384) expiration.
in 9 yr 5 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
DIMETHYL FUMARATE
Strength
240MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 204063
Product number
002
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 8399514 | in 1 yr 7 mo | U-1384 | |
| 10391160 | in 8 yr 9 mo | U-3148 | |
| 10555993 | in 8 yr 9 mo | U-3148 | |
| 10994003 | in 8 yr 9 mo | U-3148 | |
| 10959972 | in 9 yr 5 mo | U-1384 | |
| 11007166 | in 9 yr 5 mo | U-1384 | |
| 11007167 | in 9 yr 5 mo | U-1384 | |
| 11129806 | in 9 yr 5 mo | U-1384 | |
| 11246850 | in 9 yr 5 mo | U-1384 |
Active-ingredient family
Brand + generics
This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025Dimethyl FumarateGeneric (ANDA)
ANDA 210390 · Torrent
- 2024Dimethyl FumarateGeneric (ANDA)
ANDA 210377 · Macleods Pharms Ltd
- 2022Dimethyl FumarateGeneric (ANDA)
ANDA 210385 · Aurobindo Pharma
- 2022Dimethyl FumarateGeneric (ANDA)
ANDA 210414 · Prinston Inc
- 2021Dimethyl FumarateGeneric (ANDA)
ANDA 210285 · Sawai USA
- 2021Dimethyl FumarateGeneric (ANDA)
ANDA 210436 · Sola Pharms
- 2020Dimethyl FumarateGeneric (ANDA)
ANDA 210382 · Twi Pharms
- 2020Dimethyl FumarateGeneric (ANDA)
ANDA 210309 · Glenmark Pharms Ltd
- 2020Dimethyl FumarateGeneric (ANDA)
ANDA 210226 · Lupin
- 2020Dimethyl FumarateGeneric (ANDA)
ANDA 210499 · Accord Hlthcare
- 2020Dimethyl FumarateGeneric (ANDA)
ANDA 210440 · Alkem Labs Ltd
- 2020Dimethyl FumarateGeneric (ANDA)
ANDA 210402 · Amneal
How to use this record responsibly
Scope, limitations, and primary sources
What to verify before making a decision
- The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
- RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
- Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
- Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
- The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.
Official FDA references
- Electronic Orange Book record
- Orange Book preface and TE-code policy
- FDA product, patent, and exclusivity data files
Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.
Tecfidera: frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.
Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 204063 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
