ATAZANAVIR SULFATE Drug Patent Profile

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When do Atazanavir Sulfate patents expire, and what generic alternatives are available?

Atazanavir Sulfate is a drug marketed by Amneal, Aurobindo Pharma, Cipla, Hetero Labs Ltd Iii, Laurus, Mylan, Teva Pharms Usa, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in ATAZANAVIR SULFATE is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atazanavir Sulfate

A generic version of ATAZANAVIR SULFATE was approved as atazanavir sulfate by TEVA PHARMS USA on April 22^nd, 2014.

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Summary for ATAZANAVIR SULFATE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	1
Patent Applications:	28
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ATAZANAVIR SULFATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATAZANAVIR SULFATE
DailyMed Link:	ATAZANAVIR SULFATE at DailyMed

Drug patent expirations by year for ATAZANAVIR SULFATE

Recent Clinical Trials for ATAZANAVIR SULFATE

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

Sponsor	Phase
ViiV Healthcare	Phase 4
GlaxoSmithKline	Phase 4

See all ATAZANAVIR SULFATE clinical trials

Pharmacology for ATAZANAVIR SULFATE

Drug Class	Protease Inhibitor
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors UDP Glucuronosyltransferases Inhibitors UGT1A1 Inhibitors

Medical Subject Heading (MeSH) Categories for ATAZANAVIR SULFATE

HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ATAZANAVIR SULFATE

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ATAZANAVIR SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REYATAZ	Capsules	atazanavir sulfate	100 mg and 150 mg	021567	1	2010-03-19
REYATAZ	Capsules	atazanavir sulfate	200 mg	021567	1	2010-02-16
REYATAZ	Capsules	atazanavir sulfate	300 mg	021567	1	2009-07-20

US Patents and Regulatory Information for ATAZANAVIR SULFATE

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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
Zydus Pharms	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	210575-003	Jun 4, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	209717-001	Jun 1, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Laurus	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	212579-003	Apr 30, 2021	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

EU/EMA Drug Approvals for ATAZANAVIR SULFATE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Reyataz	atazanavir sulfate	EMEA/H/C/000494 Reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations).The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2).Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).	Authorised	no	no	no	2004-03-01
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal