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TYBOST Drug Profile
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When do Tybost patents expire, and when can generic versions of Tybost launch?
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 sixty-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.
US ANDA Litigation and Generic Entry Outlook for Tybost
Tybost was eligible for patent challenges on August 27th, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 4th, 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.
Summary for TYBOST
| International Patents: | 262 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 3 |
| Patent Applications: | 51 |
| 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 |
|---|---|
| The Netherlands Cancer Institute | Early Phase 1 |
| ZonMw: The Netherlands Organisation for Health Research and Development | Early Phase 1 |
| Academisch Ziekenhuis Maastricht | Early Phase 1 |
Recent Litigation for TYBOST
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Gilead Sciences, Inc. v. Mylan Pharmaceuticals Inc. | 2017-02-22 |
| Gilead Sciences Inc. v. Mylan Pharmaceuticals Inc. | 2016-03-25 |
| Gilead Sciences, Inc. v. Lee | 2013-12-11 |
Pharmacology for TYBOST
Synonyms for TYBOST
| 1,3-thiazol-5-ylmethyl [(2R,5R)-5-{[(2S)-2-({[(2-isopropyl-1,3-thiazol-4-yl)methyl](methyl)carbamoyl}amino)-4-(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate |
| 1,3-thiazol-5-ylmethyl N-[(2R,5R)-5-[[(2S)-2-[[methyl-[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]-4-morpholin-4-ylbutanoyl]amino]-1,6-diphenylhexan-2-yl]carbamate |
| 1004316-88-4 |
| 2,7,10,12-Tetraazatridecanoic acid, 12-methyl-13-(2-(1-methylethyl)-4-thiazolyl)-9-(2-(4-morpholinyl)ethyl)-8,11-dioxo-3,6-bis(phenylmethyl)-, 5-thiazolylmethyl ester, (3R,6R,9S)- |
| AB0093115 |
| AB01566899_01 |
| AC-28961 |
| AKOS025404908 |
| AOB87771 |
| AS-17061 |
| BCP06630 |
| BDBM50447471 |
| CHEBI:72291 |
| CHEMBL2095208 |
| Cobicistat |
| Cobicistat (GS-9350) |
| Cobicistat (JAN/USAN/INN) |
| Cobicistat [USAN:INN] |
| Cobicistat,GS-9350 |
| Cobicistat; GS-9350 |
| cobicistatum |
| CS-0742 |
| D09881 |
| DB09065 |
| DTXSID00143269 |
| EX-A2578 |
| GS 9350 |
| GS-9350 |
| GTPL7535 |
| HY-10493 |
| KB-76152 |
| KS-00000T52 |
| LW2E03M5PG |
| MolPort-035-395-741 |
| QCR-199 |
| s2900 |
| SB16687 |
| SCHEMBL2736227 |
| SW219553-1 |
| Thiazol-5-ylmethyl ((1R,4R)-1-benzyl-4-({(2S)-2-((methyl{(2-(1-methylethyl)thiazol-4-yl)methyl}carbamoyl)amino)-4-(morpholin-4-yl)butanoyl}amino)-5-phenylpentyl)carbamate |
| thiazol-5-ylmethyl ((2R,5R)-5-((S)-2-(3-((2-isopropylthiazol-4-yl)methyl)-3-methylureido)-4-morpholinobutanamido)-1,6-diphenylhexan-2-yl)carbamate |
| thiazol-5-ylmethyl (2R,5R)-5-((S)-2-(3-((2-isopropylthiazol-4-yl)methyl)-3-methylureido)-4-morpholinobutanamido)-1,6-diphenylhexan-2-ylcarbamate |
| thiazol-5-ylmethyl N-[(1R,4R)-1-benzyl-4-[[(2S)-2-[[(2-isopropylthiazol-4-yl)methyl-methyl-carbamoyl]amino]-4-morpholino-butanoyl]amino]-5-phenyl-pentyl]carbamate |
| Tybost (TN) |
| UNII-LW2E03M5PG |
| ZCIGNRJZKPOIKD-CQXVEOKZSA-N |
| ZINC85537014 |
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 |
|---|---|---|
| Japan | 2017171695 | Start Trial |
| Lithuania | 2487166 | Start Trial |
| Poland | 2487161 | Start Trial |
| Canada | 2692331 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TYBOST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2487163 | C20170001 00217 | Estonia | Start Trial | PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015 |
| 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 |
| 2487163 | 1790002-8 | Sweden | Start Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715 |
| 2049506 | 2015C/058 | Belgium | Start Trial | PRODUCT NAME: COBICISTAT; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
