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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. Nine 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: | 22 |
| 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 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 |
| AIDS Clinical Trials Group | Phase 3 |
Pharmacology for EPZICOM
Anatomical Therapeutic Chemical (ATC) Classes for EPZICOM
Paragraph IV (Patent) Challenges for EPZICOM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EPZICOM | TABLET;ORAL | abacavir sulfate; lamivudine | 021652 | 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 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free 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 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPZICOM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | H0892252 | ⤷ Sign up for a Free Trial |
| Norway | 995621 | ⤷ Sign up for a Free Trial |
| Canada | 2070230 | ⤷ Sign up for a Free Trial |
| African Regional IP Organization (ARIPO) | 182 | ⤷ Sign up for a Free Trial |
| Eurasian Patent Organization | 001809 | ⤷ Sign up for a Free Trial |
| Estonia | 9900537 | ⤷ Sign up for a Free Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EPZICOM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0434450 | 33/1999 | Austria | ⤷ Sign up for a Free Trial | PRODUCT NAME: ''ABACAVIR'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS, EINSCHLIESSLICH ABACAVIR-SULFAT.; NAT. REGISTRATION NO/DATE: EU/1/99/112/001 EU/1/99/112/002 19990708; FIRST REGISTRATION: LI 55048 001, 55049 002 19990628 |
| 0817637 | C00817637/01 | Switzerland | ⤷ Sign up for a Free Trial | PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005 |
| 0434450 | 990028 | Netherlands | ⤷ Sign up for a Free 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 | 19675032 | Germany | ⤷ Sign up for a Free Trial | PRODUCT NAME: LAMIVUDINE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH GEEIGNETEN SALZES; NAT. REGISTRATION NO/DATE: EU/1/96/015/001-002 19960808 FIRST REGISTRATION: CH 53662 53663 19960228 |
| 0382526 | C960025 | Netherlands | ⤷ Sign up for a Free 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 |
| 0817637 | 300195 | Netherlands | ⤷ Sign up for a Free Trial | 300195, 20160328, EXPIRES: 20191216 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
