AVALIDE Drug Patent Profile
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Which patents cover Avalide, and what generic alternatives are available?
Avalide is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in AVALIDE is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for AVALIDE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 3 |
Patent Applications: | 78 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AVALIDE |
What excipients (inactive ingredients) are in AVALIDE? | AVALIDE excipients list |
DailyMed Link: | AVALIDE at DailyMed |
Recent Clinical Trials for AVALIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bayer | Phase 3 |
Roxane Laboratories | N/A |
Pharmacology for AVALIDE
Drug Class | Angiotensin 2 Receptor Blocker Thiazide Diuretic |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for AVALIDE
Paragraph IV (Patent) Challenges for AVALIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AVALIDE | Tablets | hydrochlorothiazide; irbesartan | 300 mg/25 mg | 020758 | 1 | 2006-06-06 |
AVALIDE | Tablets | hydrochlorothiazide; irbesartan | 150 mg/12.5 mg and 300 mg/12.5 mg | 020758 | 1 | 2004-11-10 |
US Patents and Regulatory Information for AVALIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-001 | Sep 30, 1997 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-004 | Mar 15, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-002 | Sep 30, 1997 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 AVALIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-001 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-003 | Aug 31, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-004 | Mar 15, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for AVALIDE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
sanofi-aventis groupe | Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) | irbesartan, hydrochlorothiazide | EMEA/H/C/000783 Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. |
Authorised | no | no | no | 2007-01-18 | |
Sanofi Winthrop Industrie | Karvezide | irbesartan, hydrochlorothiazide | EMEA/H/C/000221 Treatment of essential hypertension.This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. |
Authorised | no | no | no | 1998-10-16 | |
Sanofi Winthrop Industrie | CoAprovel | irbesartan, hydrochlorothiazide | EMEA/H/C/000222 Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. |
Authorised | no | no | no | 1998-10-14 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for AVALIDE
See the table below for patents covering AVALIDE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 69129606 | ⤷ Try a Trial | |
Hungary | 913603 | ⤷ Try a Trial | |
European Patent Office | 0532410 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AVALIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0565634 | 06C0030 | France | ⤷ Try a Trial | PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607 |
0454511 | 24/1998 | Austria | ⤷ Try a Trial | PRODUCT NAME: ''IRBESARTAN'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE; NAT. REGISTRATION NO/DATE: EU/1/97/046/001 - EU/1/97/046/009 19970827; FIRST REGISTRATION: LI 5425002 19970815 |
0454511 | 98C0028 | Belgium | ⤷ Try a Trial | PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |