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FORFIVO XL Drug Profile
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Which patents cover Forfivo Xl, and what generic alternatives are available?
Forfivo Xl is a drug marketed by Alvogen and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has one patent family member in one country.
The generic ingredient in FORFIVO XL 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 Forfivo Xl
A generic version of FORFIVO XL was approved as bupropion hydrochloride by APNAR PHARMA LP on January 25th, 2020.
Summary for FORFIVO XL
| International Patents: | 1 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 104 |
| Patent Applications: | 901 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FORFIVO XL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FORFIVO XL |
| DailyMed Link: | FORFIVO XL at DailyMed |
Recent Litigation for FORFIVO XL
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| INTELGENX CORP. v. WOCKHARDT BIO, AG | 2013-08-23 |
Pharmacology for FORFIVO XL
| Drug Class | Aminoketone |
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Synonyms for FORFIVO XL
| ( 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 |
| 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 FORFIVO XL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FORFIVO XL | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrochloride | 022497 | 2013-02-28 |
US Patents and Regulatory Information for FORFIVO XL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alvogen | FORFIVO XL | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022497-001 | Nov 10, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for FORFIVO XL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2008038155 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FORFIVO XL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 300918 | Netherlands | Start Trial | PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
| 2316456 | C201730057 | Spain | Start Trial | PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326 |
| 0467488 | SPC/GB00/019 | United Kingdom | Start Trial | PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607 |
| 2316456 | 2017C/064 | Belgium | Start Trial | PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: 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 |
| 2316456 | 2017/059 | Ireland | 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; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
| 2316456 | 65/2017 | Austria | Start Trial | PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
