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HEPSERA Drug Profile
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» See Plans and PricingWhich patents cover Hepsera, and when can generic versions of Hepsera launch?
Hepsera is a drug marketed by Gilead and is included in one NDA.
The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.
US ANDA Litigation and Generic Entry Outlook for Hepsera
A generic version of HEPSERA was approved as adefovir dipivoxil by SIGMAPHARM LABS LLC on August 29th, 2013.
Summary for HEPSERA
Recent Clinical Trials for HEPSERA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| DongGuk University | Phase 4 |
| Yeungnam University | Phase 4 |
| Daegu Catholic University Medical Center | Phase 4 |
Recent Litigation for HEPSERA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| United States v. Gilead Sciences, Inc. | 2019-11-06 |
| Gilead Sciences v. Sigmapharm Labs | 2014-05-05 |
| GILEAD SCIENCES, INC. v. SIGMAPHARM LABORATORIES, LLC | 2010-09-24 |
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-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(Pivaloyloxymethoxy)phosphorylmethoxy]ethyl)adenine |
| 9-[2-[Bis(pivaloyloxymethoxy)phosphorylmethoxy]ethyl]adenine |
| A807894 |
| AB0012816 |
| AB01274706_02 |
| AB01274706-01 |
| AB07592 |
| AB2000245 |
| AC-1693 |
| 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) |
| Adefovir-Dipivoxil(Preveon) |
| Adefovirdipivoxil |
| Adefovirdipivoxl |
| AK546547 |
| AKOS005145737 |
| ANW-43238 |
| API0001387 |
| ARONIS27063 |
| B2222 |
| BCP0726000157 |
| BCP22959 |
| BCP9000232 |
| BCPP000434 |
| BDBM50248359 |
| bis-POM PMEA |
| Bis-POM PMEA, 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 |
| BRD-K96159438-001-03-0 |
| C-22950 |
| C20H32N5O8P |
| CA0117 |
| CAS-142340-99-6 |
| CC-23770 |
| CHEMBL922 |
| CS-2240 |
| CTK8B3813 |
| D01655 |
| DB00718 |
| 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 |
| Hepsera (TM) |
| Hepsera (TN) |
| HMS3604F09 |
| HMS3655I04 |
| HY-B0255 |
| KS-00000L27 |
| KS-000048K6 |
| LS-173141 |
| MCULE-6257358029 |
| MFCD00869897 |
| MLS003915635 |
| MLS004774124 |
| NCGC00164624-01 |
| NCGC00164624-02 |
| NCGC00164624-03 |
| NCGC00164624-11 |
| Piv2PMEA |
| Preveon |
| 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 |
| RTC-070886 |
| s1718 |
| SCHEMBL29729 |
| SMR002530072 |
| SR-01000931258 |
| SR-01000931258-2 |
| STL257088 |
| SW219933-1 |
| TC-070886 |
| Tox21_112243 |
| Tox21_112243_1 |
| U6Q8Z01514 |
| UNII-U6Q8Z01514 |
| W-2203 |
| YouHeDing |
| ZINC3930376 |
Paragraph IV (Patent) Challenges for HEPSERA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HEPSERA | TABLET;ORAL | adefovir dipivoxil | 021449 | 2010-06-08 |
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 | 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 HEPSERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | Start Trial | Start Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | Start Trial | Start Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | Start Trial | Start Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | Start Trial | Start Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HEPSERA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 3686002 | Start Trial |
| Norway | 174510 | Start Trial |
| China | 1900091 | Start Trial |
| Malaysia | 129451 | Start Trial |
| Japan | 2001512712 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for HEPSERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0481214 | C300131 | Netherlands | Start Trial | 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 |
| 0481214 | 300131 | Netherlands | Start Trial | 300131, 20110910, EXPIRES: 20160909 |
| 0481214 | 03C0034 | France | Start Trial | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306 |
| 0481214 | 91036 | Luxembourg | Start Trial | 91036, EXPIRES: 20160910 |
| 0481214 | SPC/GB03/030 | United Kingdom | Start Trial | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
