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Details for New Drug Application (NDA): 021449
NDA 021449 describes HEPSERA, which is a drug marketed by Gilead and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the HEPSERA profile page.
The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.
The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.
Summary for 021449
| Tradename: | HEPSERA |
| Applicant: | Gilead |
| Ingredient: | adefovir dipivoxil |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021449
| Ingredient-type | Nucleoside Analog |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 021449
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449 | NDA | Excella GmbH | 46014-0501 | 46014-0501-1 | 30 TABLET in 1 BOTTLE, PLASTIC (46014-0501-1) |
| HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449 | NDA | Gilead Sciences, Inc. | 61958-0501 | 61958-0501-1 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-0501-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 20, 2002 | TE: | AB | RLD: | Yes | ||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Jul 23, 2018 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION | ||||||||
Expired US Patents for NDA 021449
| 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 Free Trial | ➤ Try a Free Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Gilead | HEPSERA | adefovir dipivoxil | TABLET;ORAL | 021449-001 | Sep 20, 2002 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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