ZIAGEN Drug Patent Profile
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Which patents cover Ziagen, and what generic alternatives are available?
Ziagen is a drug marketed by Viiv Hlthcare and is included in two NDAs.
The generic ingredient in ZIAGEN is abacavir sulfate. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the abacavir sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ziagen
A generic version of ZIAGEN was approved as abacavir sulfate by MYLAN PHARMS INC on June 18th, 2012.
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Questions you can ask:
- What is the 5 year forecast for ZIAGEN?
- What are the global sales for ZIAGEN?
- What is Average Wholesale Price for ZIAGEN?
Summary for ZIAGEN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 15 |
Patent Applications: | 4,788 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ZIAGEN |
What excipients (inactive ingredients) are in ZIAGEN? | ZIAGEN excipients list |
DailyMed Link: | ZIAGEN at DailyMed |
![ZIAGEN drug patent expirations Drug patent expirations by year for ZIAGEN](/p/graph/s/t/ZIAGEN-patent-expirations.png)
![Drug Prices for ZIAGEN](/p/graph/drug-price/ZIAGEN.png)
Paragraph IV (Patent) Challenges for ZIAGEN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZIAGEN | Oral Solution | abacavir sulfate | 20 mg/mL | 020978 | 1 | 2012-12-27 |
ZIAGEN | Tablets | abacavir sulfate | 300 mg | 020977 | 1 | 2009-01-28 |
US Patents and Regulatory Information for ZIAGEN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | ZIAGEN | abacavir sulfate | SOLUTION;ORAL | 020978-001 | Dec 17, 1998 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Viiv Hlthcare | ZIAGEN | abacavir sulfate | TABLET;ORAL | 020977-001 | Dec 17, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 ZIAGEN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | ZIAGEN | abacavir sulfate | SOLUTION;ORAL | 020978-001 | Dec 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | ZIAGEN | abacavir sulfate | TABLET;ORAL | 020977-001 | Dec 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | ZIAGEN | abacavir sulfate | SOLUTION;ORAL | 020978-001 | Dec 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | ZIAGEN | abacavir sulfate | TABLET;ORAL | 020977-001 | Dec 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | ZIAGEN | abacavir sulfate | SOLUTION;ORAL | 020978-001 | Dec 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | ZIAGEN | abacavir sulfate | SOLUTION;ORAL | 020978-001 | Dec 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZIAGEN
See the table below for patents covering ZIAGEN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Finland | 20001175 | ⤷ Sign Up | |
Serbia | 49953 | FARMACEUTSKI PREPARATI (PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
Malaysia | 121043 | PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
European Patent Office | 0983271 | HEMISULFATE DE NUCLEOSIDE CARBOCYCLIQUE ET SON UTILISATION DANS LE TRAITEMENT D'INFECTIONS VIRALES (CARBOCYCLIC NUCLEOSIDE HEMISULFATE AND ITS USE IN TREATING VIRAL INFECTIONS) | ⤷ Sign Up |
African Regional IP Organization (ARIPO) | 196 | Therapeutic nucleosides | ⤷ Sign Up |
Denmark | 315689 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZIAGEN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0434450 | C990028 | Netherlands | ⤷ Sign Up | 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 |
0817637 | C00817637/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005 |
0434450 | 990028 | Netherlands | ⤷ Sign Up | 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 |
0817637 | C300195 | Netherlands | ⤷ Sign Up | 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 |
0434450 | SPC/GB99/032 | United Kingdom | ⤷ Sign Up | 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 |
0817637 | 05C0022 | France | ⤷ Sign Up | PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |