AVAPRO Drug Patent Profile
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Which patents cover Avapro, and when can generic versions of Avapro launch?
Avapro is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in AVAPRO is irbesartan. There are thirty-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the irbesartan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Avapro
A generic version of AVAPRO was approved as irbesartan by TEVA PHARMS on March 30th, 2012.
Summary for AVAPRO
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 14 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AVAPRO |
| What excipients (inactive ingredients) are in AVAPRO? | AVAPRO excipients list |
| DailyMed Link: | AVAPRO at DailyMed |
Recent Clinical Trials for AVAPRO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina | Phase 1/Phase 2 |
| Duke University | Phase 1/Phase 2 |
| Clinical Research Management, Inc. | Phase 1/Phase 2 |
Pharmacology for AVAPRO
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for AVAPRO
Paragraph IV (Patent) Challenges for AVAPRO
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AVAPRO | Tablets | irbesartan | 75 mg, 150 mg and 300 mg | 020757 | 1 | 2004-05-25 |
US Patents and Regulatory Information for AVAPRO
| 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 | AVAPRO | irbesartan | TABLET;ORAL | 020757-001 | Sep 30, 1997 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-002 | Sep 30, 1997 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-003 | 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 AVAPRO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-002 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-002 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-003 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-001 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-003 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-001 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for AVAPRO
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Sanofi Winthrop Industrie | Karvea | irbesartan | EMEA/H/C/000142 Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal product regimen. |
Authorised | no | no | no | 1997-08-26 | |
| Sanofi Winthrop Industrie | Aprovel | irbesartan | EMEA/H/C/000141 Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen. |
Authorised | no | no | no | 1997-08-26 | |
| Zentiva k.s. | Irbesartan Zentiva (previously Irbesartan Winthrop) | irbesartan | EMEA/H/C/000785 Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen. |
Authorised | no | no | no | 2007-01-19 | |
| Teva B.V. | Irbesartan Teva | irbesartan | EMEA/H/C/001093 Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen. |
Authorised | yes | no | no | 2009-10-30 | |
| Krka, d.d., Novo mesto | Ifirmasta (previously Irbesartan Krka) | irbesartan | EMEA/H/C/000962 Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen. |
Authorised | yes | no | no | 2008-12-01 | |
| Pharmathen S.A. | Sabervel | irbesartan | EMEA/H/C/002510 Sabervel is indicated in adults for the treatment of essential hypertension.It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen. |
Withdrawn | yes | no | no | 2012-04-13 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for AVAPRO
See the table below for patents covering AVAPRO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2077967 | ⤷ Try a Trial | |
| Ireland | 910913 | ⤷ Try a Trial | |
| New Zealand | 286612 | MEDICAMENTS CONTAINING 2-N-BUTYL-4-SPIRO-CYCLOPENTANE-1-[(2'-(TETRAZOL-5YL)BIPHENYL- 4-YL)METHYL]-2-IMIDAZOLIN-5-ONE (IRBESARTAN) | ⤷ Try a Trial |
| Israel | 118309 | PHARMACEUTICAL COMPOSITIONS CONTAINING IRBESARTAN AND OPTIONALLY A DIURETIC COMPOUND | ⤷ Try a Trial |
| Netherlands | 990006 | ⤷ Try a Trial | |
| Russian Federation | 2210368 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ИРБЕСАРТАН (IRBESARTAN-CONTAINING PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AVAPRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0454511 | 10/1999 | Austria | ⤷ Try a Trial | PRODUCT NAME: ''IRBESARTAN'' ZUSAMMEN MIT ''HYDROCHLOROTHIAZID''; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015 |
| 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 | 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 | 99C0009 | Belgium | ⤷ Try a Trial | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 |
| 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 |
| 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
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Privacy and Cookies
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DrugPatentWatch Alternatives
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