HEPSERA Drug Patent Profile
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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.
DrugPatentWatch® 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 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 115 |
Clinical Trials: | 19 |
Patent Applications: | 5,359 |
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 |
---|---|
Yeungnam University Hospital | Phase 4 |
Daegu Catholic University Medical Center | Phase 4 |
Yeungnam University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for HEPSERA
Paragraph IV (Patent) Challenges for HEPSERA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
HEPSERA | Tablets | adefovir dipivoxil | 10 mg | 021449 | 1 | 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | See Plans and Pricing | See Plans and Pricing |
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | See Plans and Pricing | See Plans and Pricing |
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | See Plans and Pricing | See Plans and Pricing |
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HEPSERA
See the table below for patents covering HEPSERA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 580151 | See Plans and Pricing | |
Japan | H0692307 | See Plans and Pricing | |
Australia | 5632886 | See Plans and Pricing | |
Canada | 1272956 | UTILISATION THERAPEUTIQUE DE PHOSPHONYLMETHOXY-ALKYL- ADENINES (THERAPEUTICAL APPLICATION OF PHOSPHONYLMETHOXY-ALKYL ADENINES) | See Plans and Pricing |
Philippines | 23112 | THERAPEUTICAL APPLICATION OF PHOSPHONYLMETHOXYALKYL ADENINES | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HEPSERA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0481214 | C300131 | Netherlands | See Plans and Pricing | 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 | 03C0034 | France | See Plans and Pricing | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306 |
0481214 | 91036 | Luxembourg | See Plans and Pricing | 91036, EXPIRES: 20160910 |
0481214 | SPC/GB03/030 | United Kingdom | See Plans and Pricing | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306 |
0481214 | 300131 | Netherlands | See Plans and Pricing | 300131, 20110910, EXPIRES: 20160909 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |