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Last Updated: March 19, 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
Acrotech Biopharma LLCPhase 1
Axis Clinicals LimitedPhase 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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-004 Oct 16, 2006 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-001 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-003 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-003 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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 ⤷  Try a Trial
South Korea 20010034221 ⤷  Try a Trial
Ukraine 59432 БИСУЛЬФАТ ИНГИБИТОРА ВИЧ-ПРОТЕАЗЫ;МОНОСУЛЬФАТ АЗАПЕПТИДНОГО ПОХІДНОГО ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ЙОГО ОСНОВІ (HIV protease inhibitor bisulfate) ⤷  Try a Trial
Poland 342019 ⤷  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
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
2487163 300859 Netherlands ⤷  Try a Trial 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
2487163 2016C/066 Belgium ⤷  Try a Trial PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715
2487163 PA2016039 Lithuania ⤷  Try a Trial PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.