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WELLBUTRIN SR Drug Profile
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» See Plans and PricingWhen do Wellbutrin Sr patents expire, and when can generic versions of Wellbutrin Sr launch?
Wellbutrin Sr is a drug marketed by Glaxosmithkline and is included in one NDA.
The generic ingredient in WELLBUTRIN SR is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Sixty-nine 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 Sr
A generic version of WELLBUTRIN SR was approved as bupropion hydrochloride by APNAR PHARMA LP on February 7th, 2000.
Summary for WELLBUTRIN SR
Recent Clinical Trials for WELLBUTRIN SR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Kansas Medical Center | Phase 3 |
| Duke University | Phase 4 |
| Yale University | Phase 4 |
Recent Litigation for WELLBUTRIN SR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Purdue Pharma L.P. v. PAR Pharmaceutical, Inc. | 2013-05-17 |
| Purdue Pharma LP v. Sandoz Inc. | 2012-10-10 |
| Purdue Pharma L.P. v. PAR Pharmaceutical, Inc. | 2012-07-20 |
Pharmacology for WELLBUTRIN SR
| Drug Class | Aminoketone |
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Synonyms for WELLBUTRIN SR
| ( 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 |
| (+/-)-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 |
| 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-hydrochloride(Bupropion) |
| Amfebutamone(Bupropion) |
| ANW-42367 |
| API0001440 |
| AX8118984 |
| B-102 |
| B3649 |
| 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 |
| BVF 033 |
| BW 322U |
| 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 |
| J10311 |
| 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 |
| Q27295463 |
| 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 |
| Wellbatrin |
| Wellbutrin |
| Wellbutrin (TN) |
| Wellbutrin Retard |
| Wellbutrin XL |
| Wellbutrin XR |
| Wellbutrin;Zyban;Voxra;Budeprion;Aplenzin;Bupropion |
| Zyban |
| Zyban (pharmaceutical) |
| Zyban (TN) |
Paragraph IV (Patent) Challenges for WELLBUTRIN SR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| WELLBUTRIN SR | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrochloride | 020358 |
US Patents and Regulatory Information for WELLBUTRIN SR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-001 | Oct 4, 1996 | DISCN | No | 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 | 020358-002 | Oct 4, 1996 | AB1 | 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 SR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-001 | Oct 4, 1996 | Start Trial | Start Trial |
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-003 | Oct 4, 1996 | Start Trial | Start Trial |
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-002 | Oct 4, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for WELLBUTRIN SR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 9203816 | Start Trial |
| Taiwan | 260607 | Start Trial |
| Israel | 127919 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for WELLBUTRIN SR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 1790064-8 | Sweden | Start Trial | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330 |
| 2316456 | 132017000142109 | Italy | Start Trial | PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330 |
| 2316456 | C 2017 047 | Romania | Start Trial | PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
