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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Moodys
Johnson and Johnson
Express Scripts
Medtronic
McKinsey
Merck
Citi
Dow

Generated: November 21, 2018

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ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE - Generic Drug Details

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What are the generic sources for abacavir sulfate; lamivudine; zidovudine and what is the scope of abacavir sulfate; lamivudine; zidovudine patent protection?

Abacavir sulfate; lamivudine; zidovudine is the generic ingredient in two branded drugs marketed by Lupin Ltd and Viiv Hlthcare, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for abacavir sulfate; lamivudine; zidovudine. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Tentative approvals for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free TrialEQ 300MG BASE; 150MG; 300MGTABLET; ORAL

US Patents and Regulatory Information for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912-001 Dec 5, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Viiv Hlthcare TRIZIVIR abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 021205-001 Nov 14, 2000 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try 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

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Expired US Patents for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

International Patents for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Supplementary Protection Certificates for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817637/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
C/GB99/032 United Kingdom ➤ Try a Free 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
/2005 Austria ➤ Try a Free 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
0028 Netherlands ➤ Try 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
/1999 Austria ➤ Try 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
99C0033 Belgium ➤ Try a Free Trial PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
00195 Netherlands ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Moodys
Johnson and Johnson
Express Scripts
Medtronic
McKinsey
Merck
Citi
Dow

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