FDA Orange Book · active-ingredient family
Duloxetine hydrochloride
Duloxetine hydrochloride: 3 brands, 23 generics; first approved Aug 03, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 23 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
23
Listed patents
5
Next patent expiry
Apr 13, 2037
in 10 yr 10 mo
Brand (NDA) products
Originator applications
- DULOXETINE HYDROCHLORIDERLDRSALMATICANDA 21913120263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 80MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx — EQ 90MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx — EQ 120MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx — - SUN PHARMNDA 21251620194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx — EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx — EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx — EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx — - CYMBALTARLDLILLYNDA 02142720043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued —
Generic (ANDA) products (23)
Abbreviated applications
- DULOXETINE HYDROCHLORIDESUNSHINEANDA 21232820213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEYAOPHARMA CO LTDANDA 20721920193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DULOXETINE HYDROCHLORIDEQINGDAO BAHEAL PHARMANDA 21059920193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDECSPC OUYIANDA 21131020183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEPRINSTON INCANDA 20665320173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEMACLEODS PHARMS LTDANDA 20481520173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEAJANTA PHARMA LTDANDA 20870620174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEHETERO LABS LTD IIIANDA 20434320163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEINVENTIAANDA 20233620153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEPH HEALTHANDA 09078020153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DULOXETINE HYDROCHLORIDEALKEM LABS LTDANDA 20319720153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEAPOTEXANDA 20204520143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DULOXETINE HYDROCHLORIDEBRECKENRIDGEANDA 20308820144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEALEMBICANDA 20294920143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEZYDUS HLTHCAREANDA 09073920144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEZYDUS PHARMSANDA 09072820143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 09077620133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDEADAPTISANDA 09072320133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DULOXETINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 09077820133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDELUPINANDA 09069420134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - DULOXETINE HYDROCHLORIDESUN PHARMANDA 09074520133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DULOXETINE HYDROCHLORIDETEVA PHARMS USAANDA 09078320133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - DULOXETINE HYDROCHLORIDETORRENTANDA 09077420133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 30MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 60MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9839626 | in 10 yr 10 mo | Product | |
| 10413525 | in 10 yr 10 mo | Product | |
| 12171742 | in 10 yr 10 mo | Product | |
| 11202772 | in 10 yr 10 mo | Product | |
| 10959982 | in 10 yr 10 mo | Product |
Approval history
FDA approval span
First approval
22 yr 4 mo ago
Most recent approval
6 mo ago
Approvals span 2004–2026 across 26 FDA applications.
Brand (NDA) 312%
Generic (ANDA) 2388%
Duloxetine hydrochloride: 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.
