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ZIAGEN Drug Profile

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Which patents cover Ziagen, and what substitute generic drugs are available?

Ziagen is a drug marketed by Viiv Hlthcare and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-four patent family members in forty-nine countries.

The generic ingredient in ZIAGEN is abacavir sulfate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. There are sixteen tentative approvals for this compound. Additional details are available on the abacavir sulfate profile page.

Summary for Tradename: ZIAGEN

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list3
Bulk Api Vendors: see list73
Clinical Trials: see list3
Patent Applications: see list5,045
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZIAGEN at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 1998RXYesYes6,294,540*PED► SubscribeY► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 1998RXYesYes6,641,843*PED► SubscribeY► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 1998RXYesYes► Subscribe► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 1998RXYesYes6,294,540*PED► SubscribeY► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 1998RXYesYes► Subscribe► Subscribe
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Expired Patents for Tradename: ZIAGEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 19985,034,394*PED► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 19985,089,500*PED► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 19985,089,500*PED► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 19985,034,394*PED► Subscribe
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Paragraph IV activity for: ZIAGEN

Drugname Dosage Strength RLD Submissiondate
abacavirOral Solution20 mg/mlZiagen12/27/2012
abacavir sulfateTablets300 mgZiagen1/28/2009

International Patent Family for Tradename: ZIAGEN

Country Document Number Estimated Expiration
Malaysia121043► Subscribe
Slovakia284397► Subscribe
Iceland2200► Subscribe
Norway329041► Subscribe
Estonia200000459► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ZIAGEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90028Netherlands► SubscribePRODUCT 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
0028Netherlands► SubscribePRODUCT 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
0817637/01Switzerland► SubscribePRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
C/GB99/032United Kingdom► SubscribePRODUCT 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
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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