➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Boehringer Ingelheim
Johnson and Johnson
Baxter
Dow

Last Updated: January 15, 2021

DrugPatentWatch Database Preview

AVANDIA Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

When do Avandia patents expire, and what generic alternatives are available?

Avandia is a drug marketed by Sb Pharmco and is included in one NDA. There is one patent protecting this drug.

This drug has forty-five patent family members in thirty-six countries.

The generic ingredient in AVANDIA is rosiglitazone maleate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rosiglitazone maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Avandia

Avandia was eligible for patent challenges on May 25, 2003.

There are six tentative approvals for the generic drug (rosiglitazone maleate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Drug patent expirations by year for AVANDIA
Drug Prices for AVANDIA

See drug prices for AVANDIA

Recent Clinical Trials for AVANDIA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dan ZandbergPhase 2
Singapore General HospitalPhase 4
Duke-NUS Graduate Medical SchoolPhase 4

See all AVANDIA clinical trials

Paragraph IV (Patent) Challenges for AVANDIA
Tradename Dosage Ingredient NDA Submissiondate
AVANDIA TABLET;ORAL rosiglitazone maleate 021071

US Patents and Regulatory Information for AVANDIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 DISCN Yes No   Start Trial   Start Trial Y   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 AVANDIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AVANDIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0658161 C300035 Netherlands   Start Trial PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
0658161 SPC/GB01/003 United Kingdom   Start Trial PRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SOLVATES; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
0658161 SPC001/2001 Ireland   Start Trial SPC001/2001: 20050808, EXPIRES: 20140928
0658161 39/2000 Austria   Start Trial PRODUCT NAME: ROSIGLITAZONE MALEAT; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
0306228 38/2000 Austria   Start Trial PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
0658161 CA 2001 00001 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Johnson and Johnson
Moodys
Express Scripts
Boehringer Ingelheim

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 verification 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.