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Last Updated: February 26, 2024

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. Nine 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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Drug patent expirations by year for REYATAZ
Drug Prices for REYATAZ

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Recent Clinical Trials for REYATAZ

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

SponsorPhase
Axis Clinicals LimitedPhase 1
Acrotech Biopharma LLCPhase 1
University of Turin, ItalyPhase 3

See all REYATAZ clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-004 Oct 16, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-002 Jun 20, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-003 Jun 20, 2003 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate POWDER;ORAL 206352-001 Jun 2, 2014 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 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
Netherlands 300203 ⤷  Try a Trial
Japan 2009102357 BISULFATE SALT OF HIV PROTEASE INHIBITOR ⤷  Try a Trial
Spain 2178300 ⤷  Try a Trial
Canada 2317736 SEL DE BISULFATE DE L'INHIBITEUR DE LA PROTEASE DU VIH (BISULFATE SALT OF HIV PROTEASE INHIBITOR) ⤷  Try a Trial
Norway 984900 ⤷  Try a Trial
Japan 2002509136 ⤷  Try a Trial
Georgia, Republic of P20033026 Bisulfate Salt of HIV Protease Inhibitor ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REYATAZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0900210 SPC/GB05/036 United Kingdom ⤷  Try a Trial SPC/GB05/036: 20060206, EXPIRES: 20190301
2487163 381 2-2017 Slovakia ⤷  Try a Trial PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/ATAZANAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2487163 CA 2017 00003 Denmark ⤷  Try a Trial 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
2487163 60/2016 Austria ⤷  Try a Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
2487163 17C1000 France ⤷  Try a Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE SULFATE D'ATAZANAVIR; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2487163 132017000002807 Italy ⤷  Try a Trial PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E ATAZANAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE ATAZANAVIR SOLFATO(EVOTAZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1025, 20150715
2487163 122016000120 Germany ⤷  Try a Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1025 20150713
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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