ATAZANAVIR SULFATE - Generic Drug Details

What are the generic sources for atazanavir sulfate and what is the scope of freedom to operate?

Atazanavir sulfate is the generic ingredient in three branded drugs marketed by Amneal, Aurobindo Pharma, Cipla, Hetero Labs Ltd Iii, Laurus, Mylan, Teva Pharms Usa, Zydus Pharms, Bristol Myers Squibb, and Bristol, and is included in eleven NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for atazanavir sulfate. Eight suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for ATAZANAVIR SULFATE

US Patents:	2
Tradenames:	3
Applicants:	10
NDAs:	11
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	1
Patent Applications:	43
Drug Prices:	Drug price trends for ATAZANAVIR SULFATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATAZANAVIR SULFATE
What excipients (inactive ingredients) are in ATAZANAVIR SULFATE?	ATAZANAVIR SULFATE excipients list
DailyMed Link:	ATAZANAVIR SULFATE at DailyMed

See drug prices for ATAZANAVIR SULFATE

Recent Clinical Trials for ATAZANAVIR SULFATE

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

Sponsor	Phase
GlaxoSmithKline	Phase 4
ViiV Healthcare	Phase 4

See all ATAZANAVIR SULFATE clinical trials

Generic filers with tentative approvals for ATAZANAVIR SULFATE

Applicant	Application No.	Strength	Dosage Form
		300MG/100MG	TABLET; ORAL
		200MG	CAPSULE; ORAL
		150MG	CAPSULE; 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 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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd Iii	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	212278-002	Feb 2, 2022	AB	RX	No	No
Laurus	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	212579-001	Apr 30, 2021	AB	RX	No	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014		RX	Yes	Yes
Teva Pharms Usa	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	091673-002	Apr 22, 2014	AB	RX	No	No
Cipla	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	200626-001	Aug 9, 2018		DISCN	No	No
Zydus Pharms	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	210575-001	Jun 4, 2020		DISCN	No	No
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003		DISCN	Yes	No

Expired US Patents for ATAZANAVIR SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-002	Jun 20, 2003
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-001	Jun 20, 2003
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-004	Oct 16, 2006
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352-001	Jun 2, 2014
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-002	Jun 20, 2003
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567-003	Jun 20, 2003

EU/EMA Drug Approvals for ATAZANAVIR SULFATE

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