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Last Updated: September 25, 2022

REYATAZ Drug Patent Profile


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

Reyataz is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Reyataz

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

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Paragraph IV (Patent) Challenges for REYATAZ
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 REYATAZ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-001 Jun 20, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-004 Oct 16, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-002 Jun 20, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-003 Jun 20, 2003 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb REYATAZ atazanavir sulfate POWDER;ORAL 206352-001 Jun 2, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 REYATAZ

EU/EMA Drug Approvals for REYATAZ

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

International Patents for REYATAZ

See the table below for patents covering REYATAZ around the world.

Country Patent Number Title Estimated Expiration
Bulgaria 104618 See Plans and Pricing
European Patent Office 1056722 SEL DE BISULFATE DE L'INHIBITEUR DE LA PROTEASE DU VIH (BISULFATE SALT OF HIV PROTEASE INHIBITOR) See Plans and Pricing
Peru 01852000 See Plans and Pricing
Germany 69806067 See Plans and Pricing
Denmark 0900210 See Plans and Pricing
Eurasian Patent Organization 001794 ГЕТЕРОЦИКЛИЧЕСКИЕ АЗАГЕКСАНОВЫЕ ПРОИЗВОДНЫЕ С АНТИВИРУСНЫМ ДЕЙСТВИЕМ (ANTIVIRALLY ACTIVE HETEROCYCLIC AZAHEXANE DERIVATIVES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REYATAZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487163 300859 Netherlands See Plans and Pricing PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715
0900210 SPC/GB05/036 United Kingdom See Plans and Pricing SPC/GB05/036: 20060206, EXPIRES: 20190301
2487163 CA 2017 00003 Denmark See Plans and Pricing PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG ATAZANAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER ATAZANAVIRSULFAT; REG. NO/DATE: EU/1/15/1025/001-002 20150715
0900210 05C0030 France See Plans and Pricing PRODUCT NAME: ATAZANAVIR ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/03/267/001 DU 20040302; REGISTRATION NO/DATE AT EEC: EU/1/03/237/001 DU 20040302
2487163 2016/062 Ireland See Plans and Pricing PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTRATION NO/DATE: EU/1/15/1025 20160713
2487163 93353 Luxembourg See Plans and Pricing PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE SULFATE D'ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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