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. Eight 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 TEVA PHARMS USA on September 29th, 2016.
Summary for EPZICOM
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 27 |
Clinical Trials: | 21 |
Patent Applications: | 2,031 |
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 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | See Plans and Pricing | See Plans and Pricing |
Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | See Plans and Pricing | See Plans and Pricing |
Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | See Plans and Pricing | See Plans and Pricing |
>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 |
---|---|---|---|
European Patent Office | 0479822 | NUCLEOSIDES THERAPEUTIQUES (THERAPEUTIC NUCLEOSIDES) | See Plans and Pricing |
Australia | 7771991 | See Plans and Pricing | |
Canada | 2289655 | See Plans and Pricing | |
Russian Federation | 2092485 | 1,3-OXATHIOLANE, GEOMETRICAL AND OPTICAL ISOMERS THEREOF, MIXTURES OF SAID ISOMERS, METHODS OF PREPARATION THEREOF, AND PHARMACEUTICAL COMPOSITION HAVING ANTIVIRAL ACTIVITY | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EPZICOM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0817637 | SPC016/2005 | Ireland | See Plans and Pricing | SPC016/2005: 20060407, EXPIRES: 20191216 |
0817637 | C00817637/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005 |
0817637 | SPC/GB05/027 | United Kingdom | See Plans and Pricing | SPC/GB05/027: 20050922, EXPIRES: 20191216 |
0382526 | SPC/GB96/043 | United Kingdom | See Plans and Pricing | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |