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EVOTAZ Drug Profile
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Which patents cover Evotaz, and when can generic versions of Evotaz launch?
Evotaz is a drug marketed by Bristol-myers Squibb and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and eighty-two patent family members in thirty-nine countries.
The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atazanavir sulfate; cobicistat profile page.
DrugPatentWatch® Generic Entry Outlook for Evotaz
Evotaz was eligible for patent challenges on August 27, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 6, 2032. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for EVOTAZ
| International Patents: | 282 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 4 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EVOTAZ |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EVOTAZ |
| What excipients (inactive ingredients) are in EVOTAZ? | EVOTAZ excipients list |
| DailyMed Link: | EVOTAZ at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for EVOTAZ
Generic Entry Date for EVOTAZ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for EVOTAZ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St Stephens Aids Trust | Phase 1 |
| Gilead Sciences | Phase 3 |
| Bristol-Myers Squibb | Phase 1 |
Pharmacology for EVOTAZ
Paragraph IV (Patent) Challenges for EVOTAZ
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EVOTAZ | TABLET;ORAL | atazanavir sulfate; cobicistat | 206353 | 2017-09-13 |
US Patents and Regulatory Information for EVOTAZ
| 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 | EVOTAZ | atazanavir sulfate; cobicistat | TABLET;ORAL | 206353-001 | Jan 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bristol-myers Squibb | EVOTAZ | atazanavir sulfate; cobicistat | TABLET;ORAL | 206353-001 | Jan 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 EVOTAZ
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol-myers Squibb | EVOTAZ | atazanavir sulfate; cobicistat | TABLET;ORAL | 206353-001 | Jan 29, 2015 | Start Trial | Start Trial |
| Bristol-myers Squibb | EVOTAZ | atazanavir sulfate; cobicistat | TABLET;ORAL | 206353-001 | Jan 29, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EVOTAZ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101577698 | Start Trial |
| Spain | 2178300 | Start Trial |
| Singapore | 183059 | Start Trial |
| Portugal | 900210 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EVOTAZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2049506 | CA 2015 00060 | Denmark | Start Trial | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527 |
| 2487163 | 2016/062 | Ireland | Start Trial | 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 |
| 3150586 | 132020000000055 | Italy | Start Trial | PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925 |
| 2487166 | 2016/061 | Ireland | Start Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
