FDA Orange Book · active-ingredient family
Tadalafil
Tadalafil: 4 brands, 44 generics; first approved Nov 21, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 44 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
44
Listed patents
8
Next patent expiry
Dec 24, 2038
in 12 yr 5 mo
Brand (NDA) products
Originator applications
- CHEWTADZYRLDB BETTERNDA 21852720243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL Discontinued — 10MG TABLET, CHEWABLE ORAL Discontinued — 20MG TABLET, CHEWABLE ORAL Discontinued — - CMP DEV LLCNDA 2145222022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/5ML SUSPENSION ORAL Rx — - ELI LILLY CONDA 0223322009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - CIALISRLDLILLYNDA 02136820084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 2.5MG TABLET ORAL Discontinued —
Generic (ANDA) products (44)
Abbreviated applications
- TADALAFILJUBILANT GENERICSANDA 2105922026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILJUBILANT GENERICSANDA 21032920264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILSHANDONGANDA 21627920244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB1 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 - TADALAFILFOURRTS LABSANDA 21760620244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILZYDUS PHARMSANDA 2125152023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - TADALAFILNOVITIUM PHARMAANDA 21594920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TEVA PHARMS INCANDA 2169322022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILPRINSTON INCANDA 21060920224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILPRINSTON INCANDA 2106082022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILVKT PHARMAANDA 21555620214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILCHARTWELL RXANDA 21071620204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - TADALAFILSUNSHINEANDA 2134962020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILHANGZHOU BINJIANGANDA 20882420204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILUMEDICAANDA 21129820204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILMACLEODS PHARMSANDA 2072902019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILMACLEODS PHARMSANDA 20724420194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILPHARMOBEDIENTANDA 2069572019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - TADALAFILRISINGANDA 20695620193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - TADALAFILWATSON LABS INCANDA 20588520194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILACCORD HLTHCAREANDA 20916720194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILAJANTA PHARMA LTDANDA 20965420194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILALEMBICANDA 20480920194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILAMNEAL PHARMS COANDA 20974420194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILAUROBINDO PHARMA LTDANDA 20628520194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILCIPLAANDA 20953920194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILDR REDDYSANDA 21006920194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILHETERO LABS LTD IIIANDA 20990820194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILLUPINANDA 21056720194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILQILU PHARM HAINANANDA 21042020194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILSUN PHARMANDA 20893420194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILSUNSHINEANDA 21133520194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILTORRENTANDA 21183920194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILTORRENTANDA 21206220192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 40MG TABLET ORAL Rx — - TADALAFILUNICHEMANDA 20925020194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TADALAFILZYDUS PHARMSANDA 20669320194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1 - TEVA PHARMS USAANDA 2099422019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILAJANTA PHARMA LTDANDA 2103922019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILAUROBINDO PHARMA LTDANDA 2062862019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILCHARTWELL RXANDA 2105722019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILCIPLAANDA 2102552019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILDR REDDYSANDA 2101452019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILHETERO LABS LTD IIIANDA 2099072019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB2 - TADALAFILPHARMOBEDIENTANDA 2006302018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - TADALAFILTEVA PHARMS USAANDA 09014120184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB1 5MG TABLET ORAL Rx AB1 10MG TABLET ORAL Rx AB1 20MG TABLET ORAL Rx AB1
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11975006 | in 12 yr 5 mo | ProductU-3397 | |
| 12186322 | in 12 yr 5 mo | ProductU-3397 | |
| 11382917 | in 12 yr 5 mo | ProductU-3397 | |
| 11666576 | in 12 yr 5 mo | ProductU-3397 | |
| 12708626 | in 12 yr 5 mo | ProductU-3397 | |
| 12691120 | in 12 yr 5 mo | ProductU-3397 | |
| 12697338 | in 12 yr 5 mo | ProductU-3397 | |
| 12721849 | in 12 yr 5 mo | ProductU-3397 |
Approval history
FDA approval span
First approval
23 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 2003–2026 across 48 FDA applications.
Brand (NDA) 48%
Generic (ANDA) 4492%
Tadalafil: 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.
