Irbesartan - Generic Drug Details

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What are the generic sources for irbesartan and what is the scope of patent protection?

Irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem, Upsher Smith Labs, Watson Labs Inc, and Zydus Pharms Usa Inc, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for irbesartan. Twenty-two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for irbesartan

US Patents:	0
Tradenames:	2
Applicants:	23
NDAs:	23
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	125
Patent Applications:	6,891
Drug Prices:	Drug price trends for irbesartan
Drug Sales Revenues:	Drug sales revenues for irbesartan
What excipients (inactive ingredients) are in irbesartan?	irbesartan excipients list
DailyMed Link:	irbesartan at DailyMed

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Drug Sales Revenue Trends for irbesartan

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Recent Clinical Trials for irbesartan

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

Sponsor	Phase
Iain Bressendorff	Phase 2
University of Edinburgh	Phase 2
Handok Inc.	Phase 1

See all irbesartan clinical trials

Generic filers with tentative approvals for IRBESARTAN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	300MG; 25MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	300MG; 12.5MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	150MG; 12.5MG	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.

Pharmacology for irbesartan

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for irbesartan

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for IRBESARTAN

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 irbesartan

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	IRBESARTAN	irbesartan	TABLET;ORAL	203071-001	Sep 27, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa Inc	IRBESARTAN	irbesartan	TABLET;ORAL	079213-001	Sep 27, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	IRBESARTAN	irbesartan	TABLET;ORAL	200461-003	Sep 27, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa Inc	IRBESARTAN	irbesartan	TABLET;ORAL	079213-002	Sep 27, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 irbesartan

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-001	Sep 30, 1997	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-002	Sep 30, 1997	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-003	Sep 30, 1997	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-003	Sep 30, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for irbesartan

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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