ADEFOVIR DIPIVOXIL - Generic Drug Details
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What are the generic drug sources for adefovir dipivoxil and what is the scope of patent protection?
Adefovir dipivoxil
is the generic ingredient in two branded drugs marketed by Apotex, Sigmapharm Labs Llc, and Gilead, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for adefovir dipivoxil. Two suppliers are listed for this compound.
Summary for ADEFOVIR DIPIVOXIL
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 81 |
Patent Applications: | 5,453 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ADEFOVIR DIPIVOXIL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADEFOVIR DIPIVOXIL |
What excipients (inactive ingredients) are in ADEFOVIR DIPIVOXIL? | ADEFOVIR DIPIVOXIL excipients list |
DailyMed Link: | ADEFOVIR DIPIVOXIL at DailyMed |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sigmapharm Labs Llc | ADEFOVIR DIPIVOXIL | adefovir dipivoxil | TABLET;ORAL | 202051-001 | Aug 29, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apotex | ADEFOVIR DIPIVOXIL | adefovir dipivoxil | TABLET;ORAL | 205459-001 | Jul 6, 2018 | AB | RX | No | No | ⤷ 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 |
Expired US Patents for ADEFOVIR DIPIVOXIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
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