DrugPatentWatch Database Preview
ADEFOVIR DIPIVOXIL Drug Profile
» See Plans and Pricing
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. Three 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.
Summary for ADEFOVIR DIPIVOXIL
Recent Clinical Trials for ADEFOVIR DIPIVOXIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| New Discovery LLC | Phase 4 |
| Taipei Veterans General Hospital, Taiwan | Phase 4 |
| National Health and Family Planning Commission, P.R.China | Phase 4 |
Pharmacology for ADEFOVIR DIPIVOXIL
| Drug Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Paragraph IV (Patent) Challenges for ADEFOVIR DIPIVOXIL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HEPSERA | TABLET;ORAL | adefovir dipivoxil | 021449 | 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 | Start Trial | Start Trial | Start Trial | |||
| Sigmapharm Labs Llc | ADEFOVIR DIPIVOXIL | adefovir dipivoxil | TABLET;ORAL | 202051-001 | Aug 29, 2013 | AB | RX | No | No | 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 |
