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Bupropion hydrochloride - Generic Drug Details
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What are the generic sources for bupropion hydrochloride and what is the scope of freedom to operate?
Bupropion hydrochloride
is the generic ingredient in seven branded drugs marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Anchen Pharms, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alvogen, Glaxosmithkline, Valeant Intl, Alembic Pharms Ltd, Apnar Pharma Lp, Apotex Inc, Heritage Pharma, and Nalpropion, and is included in fifty-seven NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Bupropion hydrochloride has one patent family member in one country.
There are thirty-eight drug master file entries for bupropion hydrochloride. Seventy-six suppliers are listed for this compound.
Summary for bupropion hydrochloride
| International Patents: | 1 |
| US Patents: | 13 |
| Tradenames: | 7 |
| Applicants: | 31 |
| NDAs: | 57 |
| Drug Master File Entries: | 38 |
| Suppliers / Packagers: | 76 |
| Bulk Api Vendors: | 104 |
| Clinical Trials: | 323 |
| Patent Applications: | 1,309 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for bupropion hydrochloride |
| DailyMed Link: | bupropion hydrochloride at DailyMed |
Recent Clinical Trials for bupropion hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Minnesota - Clinical and Translational Science Institute | Phase 4 |
| Boston University Charles River Campus | Phase 2 |
| University of California, San Francisco | Phase 4 |
Recent Litigation for bupropion hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| INTELGENX CORP. v. WOCKHARDT BIO, AG | 2013-08-23 |
| Purdue Pharma L.P. v. PAR Pharmaceutical, Inc. | 2013-05-17 |
| Purdue Pharma LP v. Sandoz Inc. | 2012-10-10 |
Pharmacology for bupropion hydrochloride
| Drug Class | Aminoketone |
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Synonyms for bupropion hydrochloride
| ( 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 (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 SR |
| Wellbutrin XL |
| Wellbutrin XR |
| Wellbutrin;Zyban;Voxra;Budeprion;Aplenzin;Bupropion |
| Zyban |
| Zyban (pharmaceutical) |
| Zyban (TN) |
Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FORFIVO XL | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrochloride | 022497 | 2013-02-28 |
| WELLBUTRIN XL | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrochloride | 021515 | 2004-09-21 |
| WELLBUTRIN | TABLET;ORAL | bupropion hydrochloride | 018644 | |
| WELLBUTRIN SR | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrochloride | 020358 | |
| ZYBAN | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrochloride | 020711 |
US Patents and Regulatory Information for bupropion hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic Pharms Ltd | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 203013-002 | Jun 8, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sciegen Pharms Inc | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 207479-002 | Apr 12, 2017 | AB3 | RX | No | 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 bupropion hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-004 | Jun 14, 2002 | Start Trial | Start Trial |
| Glaxosmithkline | WELLBUTRIN SR | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358-004 | Jun 14, 2002 | 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 bupropion hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2008038155 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for bupropion hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 2017C/064 | Belgium | Start Trial | PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| 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 | 122017000109 | Germany | Start Trial | PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.