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Last Updated: January 22, 2020

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WELLBUTRIN Drug Profile

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When do Wellbutrin patents expire, and what generic alternatives are available?

Wellbutrin is a drug marketed by Glaxosmithkline and Valeant Intl and is included in three NDAs.

The generic ingredient in WELLBUTRIN is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Wellbutrin

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A generic version of WELLBUTRIN was approved as bupropion hydrochloride by APNAR PHARMA LP on January 22nd, 2020.

Drug patent expirations by year for WELLBUTRIN
Drug Prices for WELLBUTRIN

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Drug Sales Revenue Trends for WELLBUTRIN

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Recent Clinical Trials for WELLBUTRIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Kansas Medical CenterPhase 3
Duke UniversityPhase 4
Yale UniversityPhase 4

See all WELLBUTRIN clinical trials

Recent Litigation for WELLBUTRIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Valeant International, Bermuda v. Watson Pharmaceuticals Inc.2010-02-19

See all WELLBUTRIN litigation

Synonyms for WELLBUTRIN
( inverted question mark)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride
(.+-.)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride
(+-)-2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride
(+-)-alpha-tert-Butylamino-3-chloropropiophenone hydrochloride
(+/-)-1-(3-Chlorophenyl)-2- [(1,1-dimethylethyl)amino]- 1-propanone hydrochloride
(+/-)-1-(3-Chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride
(+/-)-2-(t-butylamino)-3'-chloropropiophenone hydrochloride
1-(3-CHLOROPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-1-PROPANONE HYDROCHLORIDE
1-Propanone, 1-(3-chlorophenyl)-2-((1,1-dimethylethyl)amino)-, hydrochloride, (+-)-
1-Propanone,1-dimethylethyl)amino]-, hydrochloride, (.+-.)-
2-(tert-Butylamino)-1-(3-chlorophenyl)-1-propanone Hydrochloride
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one HCl
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one hydrochloride
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one;hydrochloride
2-(tert-Butylamino)-3'-chloropropiophenone hydrochloride
31677-93-7
34841-36-6
4CH-007122
77B937
A820950
AB0012179
AB02273
AB2000567
AC-196
AC1L1XZA
ACM34841366
AK-75760
AKOS015844544
alpha-(tert-Butylamino)-m-chloropropiophenone hydrochloride
AM20060780
Amfebutamon hydrochlorid
Amfebutamon hydrochloride
Amfebutamone (Bupropion)
Amfebutamone (Bupropion) HCl
AMFEBUTAMONE HCl
Amfebutamone hydrochloride
Amfebutamone(Bupropion)
AN-16061
ANW-42367
API0001440
AX8118984
B3649
BC208314
BCP0726000049
BCP22394
BCP9000462
BG0117
Budeprion
Budeprion XL
Budeprion XL 300
Bupropion (hydrochloride)
Bupropion Hcl
Bupropion hydrochloride
Bupropion hydrochloride (JAN/USP)
Bupropion hydrochloride [USAN:USP:JAN]
Bupropion hydrochloride [USAN:USP]
Bupropion Hydrochloride 1.0 mg/ml in Methanol (as free base)
Bupropion hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Bupropion hydrochloride, >=98% (HPLC), solid
Bupropion Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Bupropion hydrochloride, United States Pharmacopeia (USP) Reference Standard
Bupropion hydrocloride
Bupropion SR
BW 322U; BVF 033; Amfebutamone
BW 323
BW-323
BW-323U66
CAS-31677-93-7
CCG-100911
CCG-39085
CHEBI:3220
CHEMBL1698
CPD000058423
CPI-300
CS-2503
CTK8B3357
D00817
DSSTox_CID_24561
DSSTox_GSID_44561
DSSTox_RID_80314
DTXSID6044561
EINECS 250-759-9
EINECS 252-243-9
Elontril
EU-0100166
Forfivo XL
FT-0081218
FT-0623288
HEYVINCGKDONRU-UHFFFAOYSA-N
HMS1568B20
HMS1922F09
HSDB 6988
HY-B0403A
I06-0019
I06-19
J10311
Jsp005899
KB-224632
KS-00000XL2
KS-1034
LP00166
LS-125089
M-5146
m-Chloro-alpha-tert-butylaminopropionphenone hydrochloride
m-Chloro-alpha-tert-butylaminopropiophenone hydrochloride
MFCD00055209
MLS000069376
MLS001401370
MLS002320678
NC00161
NCGC00015122-11
NCGC00016807-01
NCGC00093650-01
NCGC00093650-02
NCGC00093650-03
NCGC00093650-04
NCGC00093650-05
NCGC00180895-01
NCGC00180895-02
NCGC00255927-01
NCGC00260851-01
NSC 315851
NSC-315851
NSC-758686
NSC315851
NSC758686
Pharmakon1600-01504174
Prestwick_668
Propiophenone, 2-(tert-butylamino)-3'-chloro-, hydrochloride, (+-)-
Propiophenone, hydrochloride, (.+-.)-
PubChem20752
Quomem
S2452
SAM001246723
SC-12179
SCHEMBL41602
SMR000058423
SMR001338824
SPECTRUM1504174
SR-01000002989
SR-01000002989-10
SR-01000002989-2
ST24027672
SW196823-6
TC-010273
Tox21_110621
Tox21_110621_1
Tox21_301844
Tox21_500166
V2047
Voxra
Wellbutrin (TN)
Wellbutrin Retard
Wellbutrin SR
Wellbutrin XL
Wellbutrin XR
Wellbutrin;Zyban;Voxra;Budeprion;Aplenzin;Bupropion
Zyban
Zyban (pharmaceutical)
Zyban (TN)
Paragraph IV (Patent) Challenges for WELLBUTRIN
Tradename Dosage Ingredient NDA Submissiondate
WELLBUTRIN TABLET;ORAL bupropion hydrochloride 018644

US Patents and Regulatory Information for WELLBUTRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-004 Jun 14, 2002 AB1 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-001 Oct 4, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Valeant Intl WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-001 Aug 28, 2003 AB3 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for WELLBUTRIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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