FDA Orange Book · active-ingredient family
Afatinib dimaleate
Afatinib dimaleate: 1 brand, 2 generics; first approved Jul 12, 2013; generic available.
Generic available
Generic status & protection
Generic available: 2 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
10
Next patent expiry
Jan 13, 2026
9 mo ago
Brand (NDA) products
Originator applications
- GILOTRIFRLDBOEHRINGER INGELHEIMNDA 20129220133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 30MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (2)
Abbreviated applications
- AFATINIB DIMALEATEAPOTEXANDA 21072520263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 30MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB - AFATINIB DIMALEATEHETERO LABS LTD VANDA 21075020263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET ORAL Rx AB EQ 30MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| RE43431 | 9 mo ago | Substance | |
| RE43431*PED | 3 mo ago | ||
| 9539258 | in 16 d | U-1950 | |
| 9539258*PED | in 7 mo | ||
| 8426586 | in 3 yr | Substance | |
| 8545884 | in 3 yr 2 mo | Product | |
| 8426586*PED | in 3 yr 6 mo | ||
| 8545884*PED | in 3 yr 8 mo | ||
| 10004743 | in 3 yr 9 mo | Product | |
| 10004743*PED | in 4 yr 3 mo |
Approval history
FDA approval span
First approval
13 yr 6 mo ago
Most recent approval
3 mo ago
Approvals span 2013–2026 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Afatinib dimaleate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
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.
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