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Entecavir - Generic Drug Details
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What are the generic drug sources for entecavir and what is the scope of patent protection?
Entecavir
is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Breckenridge, Brightgene, Casi Pharms Inc, Cipla, Hetero Labs Ltd V, Mylan, Par Pharm Inc, Pharmadax Inc, Prinston Inc, Sunshine, Teva Pharms Usa, Yaopharma Co Ltd, and Zydus Pharms, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for entecavir. Twenty-one suppliers are listed for this compound.
Summary for entecavir
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 17 |
NDAs: | 18 |
Drug Master File Entries: | 18 |
Suppliers / Packagers: | 21 |
Bulk Api Vendors: | 98 |
Clinical Trials: | 210 |
Patent Applications: | 6,530 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for entecavir |
What excipients (inactive ingredients) are in entecavir? | entecavir excipients list |
DailyMed Link: | entecavir at DailyMed |
Recent Clinical Trials for entecavir
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ascentage Pharma Group Inc. | Phase 2 |
Sunshine Lake Pharma Co., Ltd. | Phase 1/Phase 2 |
Taipei City Hospital | Phase 4 |
Pharmacology for entecavir
Drug Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
US Patents and Regulatory Information for entecavir
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cipla | ENTECAVIR | entecavir | TABLET;ORAL | 206872-001 | Dec 6, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Par Pharm Inc | ENTECAVIR | entecavir | TABLET;ORAL | 206294-002 | Nov 23, 2016 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Zydus Pharms | ENTECAVIR | entecavir | TABLET;ORAL | 206745-001 | Jun 23, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Brightgene | ENTECAVIR | entecavir | TABLET;ORAL | 212126-001 | Sep 25, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Bristol Myers Squibb | BARACLUDE | entecavir | SOLUTION;ORAL | 021798-001 | Mar 29, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Breckenridge | ENTECAVIR | entecavir | TABLET;ORAL | 208721-001 | Mar 15, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Pharmadax Inc | ENTECAVIR | entecavir | TABLET;ORAL | 212106-002 | Aug 10, 2020 | 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 |
Expired US Patents for entecavir
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-001 | Mar 29, 2005 | Start Trial | Start Trial |
Bristol Myers Squibb | BARACLUDE | entecavir | SOLUTION;ORAL | 021798-001 | Mar 29, 2005 | Start Trial | Start Trial |
Bristol Myers Squibb | BARACLUDE | entecavir | SOLUTION;ORAL | 021798-001 | Mar 29, 2005 | Start Trial | Start Trial |
Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-002 | Mar 29, 2005 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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