FDA Orange Book · active-ingredient family
Bupropion hydrochloride
Bupropion hydrochloride: 5 brands, 63 generics; first approved Dec 30, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 63 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
63
Listed patents
1
Next patent expiry
Aug 23, 2028
in 2 yr 1 mo
Brand (NDA) products
Originator applications
- TWI PHARMSNDA 0224972011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 450MG TABLET, EXTENDED RELEASE ORAL Rx — - BAUSCHNDA 02151520032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - ZYBANRLDGLAXOSMITHKLINENDA 02071119972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — - GLAXOSMITHKLINENDA 02035819964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET, EXTENDED RELEASE ORAL Discontinued — 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - WELLBUTRINRLDGLAXOSMITHKLINENDA 01864419853 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued —
Generic (ANDA) products (63)
Abbreviated applications
- BUPROPION HYDROCHLORIDEMACLEODS PHARMS LTDANDA 21856720263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDEYICHANG HUMANWELLANDA 22052920263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDEANNORA PHARMAANDA 21789820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEIPCA LABS LTDANDA 20787420253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDEGRANULESANDA 21838520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDEANNORA PHARMAANDA 21680020233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDEYICHANG HUMANWELLANDA 2167662023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB2 - BUPROPION HYDROCHLORIDEGRANULESANDA 21556820222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDESUN PHARMANDA 2036502020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDESUN PHARMANDA 2002162020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEZHEJIANG JUTAI PHARMANDA 21120020202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEMICRO LABSANDA 20740320202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BUPROPION HYDROCHLORIDECADILA PHARMS LTDANDA 20860620202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BUPROPION HYDROCHLORIDEGRAVITI PHARMSANDA 21102020192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEACCORD HLTHCAREANDA 21049720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEYICHANG HUMANWELLANDA 21134720183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDEZYDUS PHARMSANDA 20156720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEYICHANG HUMANWELLANDA 21001520182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEALEMBICANDA 20301320182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BUPROPION HYDROCHLORIDETWI PHARMSANDA 21008120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEINVAGEN PHARMSANDA 20738920172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - BUPROPION HYDROCHLORIDESINOTHERAPEUTICS INCANDA 20865220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEANBISON LABANDA 20722420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEJUBILANT GENERICSANDA 20745920172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDESCIEGEN PHARMSANDA 20747920172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDELUPINANDA 09069320172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEINVAGEN PHARMSANDA 20655620162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEHERITAGE PHARMAANDA 20697520162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BUPROPION HYDROCHLORIDESCIEGEN PHARMSANDA 2061222016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB2 - BUPROPION HYDROCHLORIDESCIEGEN PHARMSANDA 20579420163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDEINVAGEN PHARMSANDA 20667420163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEPRINSTON INCANDA 20230420153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDESUN PHARMANDA 2006952014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDETORRENTANDA 20396920143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEJUBILANT GENERICSANDA 20277420133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEJUBILANT GENERICSANDA 2027752013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEWOCKHARDT LTDANDA 20218920122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDEWOCKHARDT LTDANDA 20133120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEPH HEALTHANDA 09145920113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEPH HEALTHANDA 0915202011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEWATSON LABS INCANDA 07745520103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEAUROBINDO PHARMA USAANDA 09094220102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDERISINGANDA 0909412010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEAUROBINDO PHARMA USAANDA 09032520103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDESUN PHARMANDA 07886620103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEACTAVIS LABS FL INCANDA 07909520093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDERSACTAVIS LABS FL INCANDA 0790942009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB2 - BUPROPION HYDROCHLORIDEACTAVIS LABS FL INCANDA 07771520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEIMPAX LABSANDA 07741520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEWATSON LABS INCANDA 07728520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB3 300MG TABLET, EXTENDED RELEASE ORAL Rx AB3 - BUPROPION HYDROCHLORIDESANDOZANDA 0774752008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB2 - BUPROPION HYDROCHLORIDEPH HEALTHANDA 07728420062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEAPOTEXANDA 07614320062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BUPROPION HYDROCHLORIDECHARTWELL RXANDA 0768342005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDESANDOZANDA 07684520052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEIMPAX LABSANDA 0767112004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — - BUPROPION HYDROCHLORIDEIMPAX LABSANDA 0759142004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Rx AB2 - BUPROPION HYDROCHLORIDEIMPAX LABSANDA 07591320042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDEEPIC PHARMA LLCANDA 07593220033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 150MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - BUPROPION HYDROCHLORIDEINVATECHANDA 07561320002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — - BUPROPION HYDROCHLORIDEAUROBINDO PHARMA USAANDA 07549120002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BUPROPION HYDROCHLORIDESENORES PHARMSANDA 07558420002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BUPROPION HYDROCHLORIDEHERITAGE PHARMAANDA 07531019992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7674479 | in 2 yr 1 mo | Product |
Approval history
FDA approval span
First approval
41 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 1985–2026 across 68 FDA applications.
Brand (NDA) 57%
Generic (ANDA) 6393%
Bupropion 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.
