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: | 120 |
| Clinical Trials: | 19 |
| Patent Applications: | 4,219 |
| 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 | Phase 4 |
| Keimyung University Dongsan Medical Center | Phase 4 |
| DongGuk University | Phase 4 |
Pharmacology for HEPSERA
| Drug Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for HEPSERA
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Ireland UC | Hepsera | adefovir dipivoxil | EMEA/H/C/000485 Hepsera is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1);decompensated liver disease in combination with a second agent without cross-resistance to Hepsera. |
Withdrawn | no | no | no | 2003-03-06 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for HEPSERA
See the table below for patents covering HEPSERA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | H04230694 | PRODRUG OF PHOSPHONATE | ⤷ Try a Trial |
| Slovenia | 1256584 | ⤷ Try a Trial | |
| Denmark | 0996430 | ⤷ Try a Trial | |
| Turkey | 200000224 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HEPSERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0481214 | 03C0034 | France | ⤷ Try a Trial | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306 |
| 0481214 | SPC/GB03/030 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306 |
| 0481214 | 300131 | Netherlands | ⤷ Try a Trial | 300131, 20110910, EXPIRES: 20160909 |
| 0481214 | 91036 | Luxembourg | ⤷ Try a Trial | 91036, EXPIRES: 20160910 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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