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, Breckenridge, Brightgene, Chartwell Rx, Cipla, Hetero Labs Ltd V, Prinston Inc, Rising, Sunshine, Swiss Pharm, Teva Pharms Usa, Yaopharma Co Ltd, Yung Shin Pharm, and Zydus Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for entecavir. Sixteen suppliers are listed for this compound.
Summary for entecavir
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 17 |
NDAs: | 19 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 112 |
Clinical Trials: | 243 |
Patent Applications: | 6,071 |
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 |
---|---|
Shanghai HEP Pharmaceutical Co., Ltd. | Phase 2 |
E-DA Hospital | N/A |
Shanghai Zhimeng Biopharma, Inc. | Phase 2 |
Pharmacology for entecavir
Drug Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for entecavir
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Breckenridge | ENTECAVIR | entecavir | TABLET;ORAL | 208721-001 | Mar 15, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | ENTECAVIR | entecavir | TABLET;ORAL | 206217-002 | Aug 26, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amneal Pharms | ENTECAVIR | entecavir | TABLET;ORAL | 206652-001 | Nov 12, 2015 | 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 entecavir
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol Myers Squibb | BARACLUDE | entecavir | SOLUTION;ORAL | 021798-001 | Mar 29, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-002 | Mar 29, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-001 | Mar 29, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for entecavir
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Mylan Pharmaceuticals Limited | Entecavir Mylan | entecavir | EMEA/H/C/004377 Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to |
Authorised | yes | no | no | 2017-09-18 | |
Bristol-Myers Squibb Pharma EEIG | Baraclude | entecavir | EMEA/H/C/000623 Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis;decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B. |
Authorised | no | no | no | 2006-06-26 | |
Accord Healthcare S.L.U. | Entecavir Accord | entecavir | EMEA/H/C/004458 Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:, , , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease., , , For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B., , Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to |
Authorised | yes | no | no | 2017-09-25 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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