DrugPatentWatch Database Preview
HEPSERA Drug Profile
When do Hepsera patents expire, and what generic alternatives are available?
Hepsera is a drug marketed by Gilead and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has sixty-four patent family members in twenty-five countries.
The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.
Summary for HEPSERA
| International Patents: | 64 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 93 |
| Clinical Trials: | 16 |
| Patent Applications: | 3,950 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for HEPSERA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HEPSERA |
| DailyMed Link: | HEPSERA at DailyMed |
Pharmacology for HEPSERA
| Drug Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Synonyms for HEPSERA
| ((((2-(6-amino-9H-purin-9-yl)ethoxy)methyl)phosphoryl)bis(oxy))bis(methylene) bis(2,2-dimethylpropanoate) |
| (((2-(6-Amino-9H-purin-9-yl)ethoxy)methyl)phosphinylidene)bis(oxymethylene) 2,2-dimethylpropanoate |
| (((2-(6-AMINO-9H-PURIN-9-YL)ETHOXY)METHYL)PHOSPHORYL)BIS(OXY)BIS(METHYLENE) BIS(2,2-DIMETHYLPROPANOATE) |
| ((2-(6-Amino-9H-purin-9-yl)ethoxy)methyl)phosphonic acid, diester with hydroxymethyl pivalate |
| (2-(6-AMINOPURIN-9-YL)ETHOXYMETHYL-(2,2-DIMETHYLPROPANOYLOXYMETHOXY)PHOSPHORYL)OXYMETHYL2,2-DIMETHYLPROPANOATE |
| [({[2-(6-amino-9H-purin-9-yl)ethoxy]methyl}({[(2,2-dimethylpropanoyl)oxy]methoxy})phosphoryl)oxy]methyl 2,2-dimethylpropanoate |
| [2-(6-aminopurin-9-yl)ethoxymethyl-(2,2-dimethylpropanoyloxymethoxy)phosphoryl]oxymethyl 2,2-dimethylpropanoate |
| 142340-99-6 |
| 2,2-dimethylpropanoic acid [2-(6-aminopurin-9-yl)ethoxymethyl-[(2,2-dimethyl-1-oxopropoxy)methoxy]phosphoryl]oxymethyl ester |
| 3-{[2-(6-amino-9H-purin-9-yl)ethoxy]methyl}-8,8-dimethyl-3-oxido-7-oxo-2,4,6-trioxa-3-phosphanon-1-yl pivalate (non-preferred |
| 3-{[2-(6-amino-9H-purin-9-yl)ethoxy]methyl}-8,8-dimethyl-3-oxido-7-oxo-2,4,6-trioxa-3?5-phosphanon-1-yl 2,2-dimethylpropanoate |
| 3-{[2-(6-amino-9H-purin-9-yl)ethoxy]methyl}-8,8-dimethyl-3-oxido-7-oxo-2,4,6-trioxa-3lambda~5~-phosphanon-1-yl 2,2-dimethylpropanoate |
| 340A996 |
| 9-(2-((-Bis((pivaloyloxy)methoxy)phosphinyl)methoxy)ethyl)adenine |
| 9-(2-((Bis((pivaloyloxy)methoxy)phosphinyl)methoxy)ethyl)adenine |
| 9-(2[bis(Pivaloyloxymethoxy)phosphorylmethoxy]ethyl)adenine |
| 9-[2-[Bis(pivaloyloxymethoxy)phosphorylmethoxy]ethyl]adenine |
| 9-[2-[BIS[(PIVALOYLOXY)METHOXY]PHOSPHINYL]METHOXY]ETHYL]ADENINE |
| A807894 |
| AB0012816 |
| AB01274706_02 |
| AB01274706-01 |
| AB07592 |
| AB2000245 |
| AC-1693 |
| AC1L1U36 |
| adefovir depivoxil |
| Adefovir di(pivaloyloxymethyl) ester |
| ADEFOVIR DIPIVOXIL |
| Adefovir Dipivoxil (Preveon, Hepsera) |
| Adefovir dipivoxil (USAN) |
| Adefovir dipivoxil [USAN] |
| Adefovir dipivoxil, Antibiotic for Culture Media Use Only |
| Adefovir dipivoxyl |
| Adefovir pivoxil |
| Adefovir pivoxil (JAN) |
| Adefovirdipivoxl |
| AKOS005145737 |
| Ambap142340-99-6 |
| AN-6719 |
| ANW-43238 |
| API0001387 |
| ARONIS27063 |
| B2222 |
| BC206225 |
| BCP0726000157 |
| BCP9000232 |
| BCPP000434 |
| bis-POM PMEA |
| Bis-POM PMEA, Adefovir Dipivoxil |
| Bis-POM PMEA, Preveon, Hepsera, Adefovir Dipivoxil |
| Bis-POM PMEA;Preveon;Hepsera;Preveon;Hepsera |
| Bis(pivaloyloxymethyl)-9-(2-phosphonylmethoxyethyl)adenine |
| BIS(PIVALOYLOXYMETHYL)-9-[2-(PHOSPHONOMETHOXY)ETHYL]ADENINE |
| Bis(POM)-PMEA |
| Bis(pom)PMEA |
| C-22950 |
| C20H32N5O8P |
| CA0117 |
| CAS-142340-99-6 |
| CC-23770 |
| CHEMBL922 |
| CS-2240 |
| CTK8B3813 |
| D01655 |
| D0ML1F |
| DB00718 |
| DIPIVOXIL |
| DR003071 |
| DSSTox_CID_26487 |
| DSSTox_GSID_46487 |
| DSSTox_RID_81658 |
| DTXSID5046487 |
| FT-0082875 |
| FT-0631164 |
| GP5823 |
| GS 0840 |
| GS 840 |
| GS-0840 |
| GS-3604 |
| GS-840 |
| HE310667 |
| Hepsera (TM) |
| Hepsera (TN) |
| HMS3604F09 |
| HMS3655I04 |
| HY-B0255 |
| I06-1150 |
| I14-3234 |
| KS-00000L27 |
| KS-000048K6 |
| LS-173141 |
| MCULE-6257358029 |
| MFCD00869897 |
| MLS003915635 |
| MLS004774124 |
| NCGC00164624-01 |
| NCGC00164624-02 |
| NCGC00164624-03 |
| Piv2PMEA |
| Preveon |
| Preveon (TN) |
| Propanoic acid, 2,2-dimethyl-, (((2-(6-amino-9H-purin-9-yl)ethoxy)methyl)phosphinylidene)bis(oxymethylene) ester |
| Propanoic acid,2,2-dimethyl-(((2-(6-amino-9H-purin-9-yl)ehtoxy)mehtyl)phosphinyldiene)bis(oxymehtylene)ester |
| PubChem14224 |
| Q-101927 |
| RP17773 |
| RTC-070886 |
| s1718 |
| SCHEMBL29729 |
| SMR002530072 |
| SR-01000931258 |
| SR-01000931258-2 |
| STL257088 |
| TC-070886 |
| TL8000938 |
| Tox21_112243 |
| Tox21_112243_1 |
| U6Q8Z01514 |
| UNII-U6Q8Z01514 |
| W-2203 |
| YouHeDing |
| ZINC3930376 |
US Patents and Regulatory Information for HEPSERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | |
| 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 HEPSERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ➤ Sign Up | ➤ Sign Up |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ➤ Sign Up | ➤ Sign Up |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ➤ Sign Up | ➤ Sign Up |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ➤ Sign Up | ➤ Sign Up |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for HEPSERA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 10 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for HEPSERA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Denmark | 1256585 | ➤ Sign Up |
| Japan | 2003342283 | ➤ Sign Up |
| Brazil | 9811552 | ➤ Sign Up |
| South Korea | 100700087 | ➤ Sign Up |
| Spain | 2229029 | ➤ Sign Up |
| Japan | 3573713 | ➤ Sign Up |
| Japan | 2001512712 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for HEPSERA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0034 | France | ➤ Sign Up | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306 |
| 00131 | Netherlands | ➤ Sign Up | PRODUCT NAME: ADEFOVIR DIPIVOXIL, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE ZUURADDITIE ZOUTEN, METAALZOUTEN EN SOLVATEN HIERVAN; NAT. REGISTRATION NO/DATE: EU/1/03/251/001 20030306; FIRST REGISTRATION: EU/1/03/251/001 20030306 |
| C/GB03/030 | United Kingdom | ➤ Sign Up | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
