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Generated: September 25, 2017
What is the patent landscape for Tybost, and when can generic versions of Tybost launch?
Tybost is a drug marketed by Gilead Sciences Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 23 |
| Clinical Trials: see list | 2 |
| Patent Applications: see list | 38 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | TYBOST at DailyMed |
| 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 | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||
Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||
Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| cobicistat | Tablets | 150 mg | Tybost | 12/9/2015 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,939,553 | Modulators of pharmacokinetic properties of therapeutics | ► Subscribe | |||||||||||||
| 8,383,655 | Modulators of pharmacokinetic properties of therapeutics | ► Subscribe | |||||||||||||
| 8,088,770 | Modulators of pharmacokinetic properties of therapeutics | ► Subscribe | |||||||||||||
| 8,486,942 | Modulators of pharmacokinetic properties of therapeutics | ► Subscribe | |||||||||||||
| 8,067,449 | Modulators of pharmacokinetic properties of therapeutics | ► Subscribe | |||||||||||||
| 9,139,541 | Modulators of pharmacokinetic properties of therapeutics | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 101577698 | ► Subscribe | |||||||||||||
| European Patent Office | 2487164 | ► Subscribe | |||||||||||||
| Spain | 2603645 | ► Subscribe | |||||||||||||
| Ukraine | 101312 | ► Subscribe | |||||||||||||
| Israel | 232320 | ► Subscribe | |||||||||||||
| Spain | 2525454 | ► Subscribe | |||||||||||||
| Poland | 2487166 | ► Subscribe | |||||||||||||
| Taiwan | 201412733 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 2009008989 | ► Subscribe | |||||||||||||
| China | 101679325 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016039 | Lithuania | ► Subscribe | PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713 | ||||||||||||
| C0078 | France | ► Subscribe | PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527 | ||||||||||||
| 0860 | Netherlands | ► Subscribe | 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 | ||||||||||||
| 2016040 | Lithuania | ► Subscribe | PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119 | ||||||||||||
| 2015040,C2049506 | Lithuania | ► Subscribe | PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524 | ||||||||||||
| 2 5024-2015 | Slovakia | ► Subscribe | PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/13/830 20130527 | ||||||||||||
| 2015000092 | Germany | ► Subscribe | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524 | ||||||||||||
| /2016 | Austria | ► Subscribe | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121 | ||||||||||||
| 2017 00002 | Denmark | ► Subscribe | 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 | ||||||||||||
| /2016 | Austria | ► Subscribe | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715 | ||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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