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 | |||
Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-003 | Aug 31, 1998 | 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 |
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 |
>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 | |
Krka, d.d., Novo mesto | Ifirmacombi | irbesartan, hydrochlorothiazide | EMEA/H/C/002302 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 | yes | no | no | 2011-03-04 | |
Teva B.V. | Irbesartan/Hydrochlorothiazide Teva | irbesartan, hydrochlorothiazide | EMEA/H/C/001112 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 | yes | no | no | 2009-11-26 | |
>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 |
---|---|---|---|
South Africa | 9206899 | ⤷ Try a Trial | |
Hungary | 211839 | ⤷ Try a Trial | |
Poland | 293015 | ⤷ Try a Trial | |
South Africa | 9102072 | ⤷ Try a Trial | |
Poland | 165945 | ⤷ 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 |
---|---|---|---|---|
0454511 | C990006 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAAT, EN HYDROCHLOORTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015 |
0502314 | C300095 | Netherlands | ⤷ Try a Trial | PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419 |
0502314 | SPC/GB02/037 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
0454511 | C980039 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAA T; REGISTRATION NO/DATE: EU/1/97/046/001 - 009 19970827 |
0454511 | SPC/GB99/008 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |