BARACLUDE Drug Patent Profile
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Which patents cover Baraclude, and what generic alternatives are available?
Baraclude is a drug marketed by Bristol Myers Squibb and is included in two NDAs.
The generic ingredient in BARACLUDE is entecavir. There are eighteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Baraclude
A generic version of BARACLUDE was approved as entecavir by HETERO LABS LTD V on August 21st, 2015.
Summary for BARACLUDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Clinical Trials: | 69 |
| Patent Applications: | 5,320 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BARACLUDE |
| What excipients (inactive ingredients) are in BARACLUDE? | BARACLUDE excipients list |
| DailyMed Link: | BARACLUDE at DailyMed |
Recent Clinical Trials for BARACLUDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai Zhimeng Biopharma, Inc. | Phase 2 |
| Tigermed Consulting Co., Ltd | Phase 2 |
| Ascentage Pharma Group Inc. | Phase 2 |
Pharmacology for BARACLUDE
| Drug Class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for BARACLUDE
US Patents and Regulatory Information for BARACLUDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | BARACLUDE | entecavir | SOLUTION;ORAL | 021798-001 | Mar 29, 2005 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-001 | Mar 29, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-002 | Mar 29, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 BARACLUDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-001 | Mar 29, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | BARACLUDE | entecavir | TABLET;ORAL | 021797-002 | Mar 29, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | BARACLUDE | entecavir | SOLUTION;ORAL | 021798-001 | Mar 29, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | BARACLUDE | entecavir | SOLUTION;ORAL | 021798-001 | Mar 29, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BARACLUDE
| 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 |
International Patents for BARACLUDE
See the table below for patents covering BARACLUDE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | H04282373 | HYDROXYMETHYL(METHYLENECYCLOPENTYL)- PURINES AND PYRIMIDINES | ⤷ Try a Trial |
| Finland | 914928 | ⤷ Try a Trial | |
| Germany | 122006000069 | ⤷ Try a Trial | |
| Norway | 2006018 | ⤷ Try a Trial | |
| Netherlands | 300241 | ⤷ Try a Trial | |
| Denmark | 0481754 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BARACLUDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0481754 | CA 2006 00033 | Denmark | ⤷ Try a Trial | |
| 0481754 | C00481754/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH |
| 0481754 | 91275 | Luxembourg | ⤷ Try a Trial | CERTIFICATE TITLE: ENTECAVIR ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BARACLUDE); FIRST REGISTRATION: 20060626 |
| 0481754 | SPC/GB06/032 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626 |
| 0481754 | C300241 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ENTECAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT, IN HET BIJZONDER ENTECAVIRMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/06/343/001-EU/1/06/343/005 20060626 |
| 0481754 | 33/2006 | Austria | ⤷ Try a Trial | PRODUCT NAME: ENTECAVIR UND DESSEN HYDRATE; REGISTRATION NO/DATE: EU/1/06/343/001- EU/1/06/343/005 20060626 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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