EPZICOM Drug Patent Profile
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Which patents cover Epzicom, and what generic alternatives are available?
Epzicom is a drug marketed by Viiv Hlthcare and is included in one NDA.
The generic ingredient in EPZICOM is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Epzicom
A generic version of EPZICOM was approved as abacavir sulfate; lamivudine by CHARTWELL RX on March 28th, 2017.
Summary for EPZICOM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 29 |
| Clinical Trials: | 21 |
| Patent Applications: | 2,168 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EPZICOM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPZICOM |
| What excipients (inactive ingredients) are in EPZICOM? | EPZICOM excipients list |
| DailyMed Link: | EPZICOM at DailyMed |
Recent Clinical Trials for EPZICOM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme Corp. | Phase 3 |
| AIDS Clinical Trials Group | Phase 3 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 |
Pharmacology for EPZICOM
Anatomical Therapeutic Chemical (ATC) Classes for EPZICOM
Paragraph IV (Patent) Challenges for EPZICOM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| EPZICOM | Tablets | abacavir sulfate; lamivudine | 600 mg/300 mg | 021652 | 1 | 2007-09-27 |
US Patents and Regulatory Information for EPZICOM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | DISCN | Yes | No | ⤷ 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 EPZICOM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPZICOM
See the table below for patents covering EPZICOM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 69622386 | ⤷ Try a Trial | |
| South Africa | 9010365 | ⤷ Try a Trial | |
| Greece | 3019919 | ⤷ Try a Trial | |
| Australia | 6841990 | ⤷ Try a Trial | |
| Canada | 2152269 | METHODE DE PREPARATION DE DERIVES DE SUBSTITUTION DE 1,3-OXATHIOLANES AUX PROPRIETES ANTIVIRALES (PROCESS FOR PREPARING SUBSTITUTED 1,3-OXATHIOLANES WITH ANTIVIRAL PROPERTIES) | ⤷ Try a Trial |
| Canada | 2289655 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EPZICOM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0817637 | 300195 | Netherlands | ⤷ Try a Trial | 300195, 20160328, EXPIRES: 20191216 |
| 0434450 | SPC/GB99/032 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ABACAVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE INCLUDING ABACAVIR SULPHATE; REGISTERED: CH CH 55048 001 19990628; CH CH 55049 002 19990628; UK EU/1/99/112/001 19990708; UK EU/1/99/112/002 19990708 |
| 0817637 | SPC016/2005 | Ireland | ⤷ Try a Trial | SPC016/2005: 20060407, EXPIRES: 20191216 |
| 0382526 | SPC/GB96/043 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH 53662 19960228; CH 53663 19960228; UK EU/1/96/015/001 19960808; UK EU/1/96/015/002 19960808 |
| 0817637 | 23/2005 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217 |
| 0382526 | C960025 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LAMIVUDINUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/015/001 - EU/1/96/015/002 19960808 |
| >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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