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WELLBUTRIN SR Drug Profile
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Which patents cover Wellbutrin Sr, and what generic alternatives are available?
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. Seventy-six suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
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 |
| (+/-)-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 |
| 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 | |||
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-003 | 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 |
