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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 eighty-two 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.
DrugPatentWatch® 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 6, 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: | 282 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 52 |
| Clinical Trials: | 3 |
| Patent Applications: | 612 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TYBOST |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TYBOST |
| What excipients (inactive ingredients) are in TYBOST? | TYBOST excipients list |
| DailyMed Link: | TYBOST at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| Academisch Ziekenhuis Maastricht | Early Phase 1 |
| The Netherlands Cancer Institute | Early Phase 1 |
| ZonMw: The Netherlands Organisation for Health Research and Development | Early Phase 1 |
Pharmacology for TYBOST
ATC Classes 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 | Get Started Free | Get Started Free | Y | Y | Get Started Free | ||
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| >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 |
|---|---|---|
| Singapore | 173544 | Get Started Free |
| Japan | 2010532755 | Get Started Free |
| Japan | 2012517432 | Get Started Free |
| Taiwan | I411613 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TYBOST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2487166 | 2017003 | Norway | Get Started Free | PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209 |
| 2487162 | 122016000103 | Germany | Get Started Free | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 20141119 |
| 2487162 | 284 1-2017 | Slovakia | Get Started Free | PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/DARUNAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/967 20141121 |
| 2487162 | CA 2017 00002 | Denmark | Get Started Free | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
