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.
Summary for REYATAZ
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 84 |
Clinical Trials: | 67 |
Patent Applications: | 4,646 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for REYATAZ |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REYATAZ |
What excipients (inactive ingredients) are in REYATAZ? | REYATAZ excipients list |
DailyMed Link: | REYATAZ at DailyMed |
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 |
---|---|---|---|
Canada | 2510945 | INTERMEDIAIRES UTILES DANS LA PRODUCTION DE DERIVES D'AZAHEXANE HETEROCYCLIQUES A ACTIVITE ANTIVIRALE (INTERMEDIATES USEFUL IN PRODUCTION OF ANTIVIRALLY ACTIVE HETEROCYCLIC AZAHEXANE DERIVATIVES) | ⤷ Try a Trial |
Luxembourg | 91189 | ⤷ Try a Trial | |
New Zealand | 509045 | Intermediates in the formation of antivirally active heterocyclic azahexane derivatives | ⤷ Try a Trial |
Eurasian Patent Organization | 001794 | ГЕТЕРОЦИКЛИЧЕСКИЕ АЗАГЕКСАНОВЫЕ ПРОИЗВОДНЫЕ С АНТИВИРУСНЫМ ДЕЙСТВИЕМ (ANTIVIRALLY ACTIVE HETEROCYCLIC AZAHEXANE DERIVATIVES) | ⤷ Try a Trial |
South Africa | 9703387 | ⤷ Try a Trial | |
Israel | 126381 | HETEROCYCLIC AZAHEXANE DERIVATIVES AND ANTIVIRAL COMPOSITIONS CONTAINING THEM | ⤷ Try a Trial |
Uruguay | 25345 | SAL DE BISULFATO DEL INHIBIDOR DE LA VIH-PROTEASA | ⤷ 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 | PA2016039 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713 |
0900210 | CA 2005 00037 | Denmark | ⤷ Try a Trial | |
2487163 | 2016C/066 | Belgium | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715 |
2487163 | 93353 | Luxembourg | ⤷ Try a Trial | 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 |
0900210 | 05C0030 | France | ⤷ Try a Trial | 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 | 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 | 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 |