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HEPSERA Drug Profile
» See Plans and Pricing
Which 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
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 106 |
| Clinical Trials: | 16 |
| Patent Applications: | 4,153 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for HEPSERA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HEPSERA |
| What excipients (inactive ingredients) are in HEPSERA? | HEPSERA excipients list |
| DailyMed Link: | HEPSERA at DailyMed |
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 |
Pharmacology for HEPSERA
| Drug Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
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 |
|---|---|---|
| Philippines | 23112 | Start Trial |
| Austria | 298576 | Start Trial |
| Germany | 3686002 | Start Trial |
| China | 1682743 | Start Trial |
| Hong Kong | 1091212 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for HEPSERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0481214 | 03C0034 | France | Start Trial | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306 |
| 0481214 | SPC/GB03/030 | United Kingdom | Start Trial | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306 |
| 0481214 | 300131 | Netherlands | Start Trial | 300131, 20110910, EXPIRES: 20160909 |
| 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 | 91036 | Luxembourg | Start Trial | 91036, EXPIRES: 20160910 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
