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TYBOST Drug Profile
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When do Tybost patents expire, and what generic alternatives are available?
Tybost is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and seventy patent family members in thirty-nine countries.
The generic ingredient in TYBOST is cobicistat. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat profile page.
US ANDA Litigation and Generic Entry Outlook for Tybost
Tybost 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 4, 2032. This may change due to patent challenges or generic licensing.
There have been two 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 TYBOST
| International Patents: | 270 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 3 |
| Patent Applications: | 52 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TYBOST |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TYBOST |
| DailyMed Link: | TYBOST at DailyMed |
Generic Entry Opportunity Date for TYBOST
Generic Entry Date for TYBOST*:
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 TYBOST
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | Early Phase 1 |
| Academisch Ziekenhuis Maastricht | Early Phase 1 |
| The Netherlands Cancer Institute | Early Phase 1 |
Pharmacology for TYBOST
Paragraph IV (Patent) Challenges for TYBOST
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TYBOST | TABLET;ORAL | cobicistat | 203094 | 2016-11-14 |
US Patents and Regulatory Information for TYBOST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TYBOST
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 2487166 | Start Trial |
| European Patent Office | 2487167 | Start Trial |
| Japan | 2012517432 | Start Trial |
| Japan | 4881446 | Start Trial |
| Montenegro | 02631 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TYBOST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2487166 | 300860 | Netherlands | Start Trial | PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123 |
| 2049506 | 262 5024-2015 | Slovakia | Start Trial | PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZA-; REGISTRATION NO/DATE: EU/1/13/830 20130527 |
| 2487162 | 17C1002 | France | Start Trial | PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121 |
| 2049506 | CR 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 | 300859 | Netherlands | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
