ADEFOVIR DIPIVOXIL Drug Patent Profile
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When do Adefovir Dipivoxil patents expire, and what generic alternatives are available?
Adefovir Dipivoxil is a drug marketed by Apotex and Sigmapharm Labs Llc and is included in two NDAs.
The generic ingredient in ADEFOVIR DIPIVOXIL is adefovir dipivoxil. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Adefovir Dipivoxil
A generic version of ADEFOVIR DIPIVOXIL was approved as adefovir dipivoxil by SIGMAPHARM LABS LLC on August 29th, 2013.
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Questions you can ask:
- What is the 5 year forecast for ADEFOVIR DIPIVOXIL?
- What are the global sales for ADEFOVIR DIPIVOXIL?
- What is Average Wholesale Price for ADEFOVIR DIPIVOXIL?
Summary for ADEFOVIR DIPIVOXIL
Recent Clinical Trials for ADEFOVIR DIPIVOXIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lai Wei | Phase 2 |
| New Discovery LLC | Phase 4 |
| Taipei Veterans General Hospital, Taiwan | Phase 4 |
Pharmacology for ADEFOVIR DIPIVOXIL
| Drug Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ADEFOVIR DIPIVOXIL
Paragraph IV (Patent) Challenges for ADEFOVIR DIPIVOXIL
| 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 ADEFOVIR DIPIVOXIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | ADEFOVIR DIPIVOXIL | adefovir dipivoxil | TABLET;ORAL | 205459-001 | Jul 6, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sigmapharm Labs Llc | ADEFOVIR DIPIVOXIL | adefovir dipivoxil | TABLET;ORAL | 202051-001 | Aug 29, 2013 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ADEFOVIR DIPIVOXIL
| 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 |
