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EPZICOM Drug Profile
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» See Plans and PricingWhich 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. Additional details are available on the abacavir sulfate; lamivudine profile page.
Summary for EPZICOM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 15 |
| Clinical Trials: | 21 |
| Patent Applications: | 1,824 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EPZICOM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPZICOM |
| 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 |
Recent Litigation for EPZICOM
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ASTRAZENECA PHARMACEUTICALS LP v. AGILA SPECIALTIES, INC | 2015-08-06 |
| ViiV Healthcare UK Ltd. v. Lupin Ltd. | 2011-06-29 |
| Glaxo Group Ltd. v. Lupin Ltd. | 2008-08-29 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2015-01-08 | |
| 2014-06-02 |
Synonyms for EPZICOM
| ((1R,4S)-4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)cyclopent-2-enyl)methanol |
| (1R)-4beta-[2-Amino-6-(cyclopropylamino)-9H-purine-9-yl]-2-cyclopentene-1beta-methanol |
| 136470-79-6 |
| 2-Cyclopentene-1-methanol, 4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)-, (1R-cis)- |
| 2-Cyclopentene-1-methanol, 4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)-, (1R,4S)- |
| 2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1R-cis)- |
| 2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1R,4S)- |
| Abacavir sulfate impurity A [WHO-IP] |
| AKOS015894952 |
| CTK0G9914 |
| DTXSID20332855 |
| ent-Abacavir |
| FT-0660944 |
| NCGC00241110-01 |
| Q27293722 |
| SCHEMBL52190 |
| UNII-X9A7099R51 |
| X9A7099R51 |
| ZINC4400 |
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 | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | Start Trial | Start Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | Start Trial | Start Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | Start Trial | Start Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | Start Trial | Start Trial |
| Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPZICOM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 315689 | Start Trial |
| United Kingdom | 0010222 | Start Trial |
| Hong Kong | 1009270 | Start Trial |
| Japan | H01316375 | Start Trial |
| Czech Republic | 283481 | Start Trial |
| Portugal | 93094 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EPZICOM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0817637 | 288 | Finland | Start Trial | |
| 0382526 | SZ 22/1996 | Austria | Start Trial | PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE |
| 0817637 | 300195 | Netherlands | Start Trial | 300195, 20160328, EXPIRES: 20191216 |
| 0434450 | 990028 | Netherlands | Start 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 | Start 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 | Start 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 |
