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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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