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. Seven 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 CIPLA 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 |
---|---|---|---|
Denmark | 315689 | ⤷ Try a Trial | |
United Kingdom | 0010222 | ⤷ Try a Trial | |
Hong Kong | 1009270 | ⤷ Try a Trial | |
Japan | H01316375 | 2-SUBSTITUTED-4-SUBSTITUTED-1, 3-DIOXOLANES, SYNTHESIS AND USE THEREOF | ⤷ Try a Trial |
Czech Republic | 283481 | Enantiomerní purinové deriváty, způsob jejich výroby, farmaceutické prostředky s jejich obsahem a jejich použití (ENANTIOMERIC PURINE DERIVATIVES, PROCESS OF THEIR PREPARATION, PHARMACEUTICAL COMPOSITIONS CONTAINING THEREOF AND THEIR USE) | ⤷ Try a Trial |
Portugal | 93094 | PROCESSO PARA A PREPARACAO DE 1,3-OXATIOLANOS SUBSTITUIDOS E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM | ⤷ 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 | 288 | Finland | ⤷ Try a Trial | |
0382526 | SZ 22/1996 | Austria | ⤷ Try a Trial | PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE |
0817637 | 300195 | Netherlands | ⤷ Try a Trial | 300195, 20160328, EXPIRES: 20191216 |
0434450 | 990028 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708 |
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 | C300195 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDB AAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HEMISULFAAT, EN LAMIV UDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT; REGISTRTION NO/DATE: EU/04/298/001-002 20041217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |