ROSIGLITAZONE MALEATE - Generic Drug Details
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What are the generic sources for rosiglitazone maleate and what is the scope of patent protection?
Rosiglitazone maleate
is the generic ingredient in two branded drugs marketed by Woodward and Ani Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for rosiglitazone maleate. There are six tentative approvals for this compound.
Summary for ROSIGLITAZONE MALEATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 75 |
Clinical Trials: | 22 |
Patent Applications: | 5,005 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in ROSIGLITAZONE MALEATE? | ROSIGLITAZONE MALEATE excipients list |
DailyMed Link: | ROSIGLITAZONE MALEATE at DailyMed |
Recent Clinical Trials for ROSIGLITAZONE MALEATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cetero Research, San Antonio | Phase 1 |
Mutual Pharmaceutical Company, Inc. | Phase 1 |
GlaxoSmithKline | Phase 1 |
Generic filers with tentative approvals for ROSIGLITAZONE MALEATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 8MG | TABLET; ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 4MG | TABLET; ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 2MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for ROSIGLITAZONE MALEATE
Expired US Patents for ROSIGLITAZONE MALEATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Woodward | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-004 | May 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-003 | May 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-002 | May 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-002 | May 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-002 | May 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-003 | May 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | AVANDIA | rosiglitazone maleate | TABLET;ORAL | 021071-003 | May 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |