TYBOST Drug Patent 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 ninety-five patent family members in forty 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.
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
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Questions you can ask:
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Summary for TYBOST
International Patents: | 295 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 6 |
Patent Applications: | 601 |
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 |


Recent Clinical Trials for TYBOST
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Maastricht University Medical Center | Phase 4 |
Pyramid Biosciences | Phase 1 |
Bristol-Myers Squibb | Phase 1 |
Pharmacology for TYBOST
Paragraph IV (Patent) Challenges for TYBOST
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TYBOST | Tablets | cobicistat | 150 mg | 203094 | 1 | 2016-11-14 |
US Patents and Regulatory Information for TYBOST
TYBOST is protected by two US patents and one FDA Regulatory Exclusivity.
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 | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Gilead Sciences Inc | TYBOST | cobicistat | TABLET;ORAL | 203094-001 | Sep 24, 2014 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for TYBOST
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Ireland UC | Tybost | cobicistat | EMEA/H/C/002572 Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir. |
Authorised | no | no | no | 2013-09-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TYBOST
When does loss-of-exclusivity occur for TYBOST?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 89
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷ Try for Free
Patent: 50
Patent: Tablets for combination therapy
Estimated Expiration: ⤷ Try for Free
Argentina
Patent: 5369
Patent: COMPRIMIDOS PARA TERAPIA DE COMBINACION PARA EL TRATAMIENTO DE INFECCIONES VIRALES.
Estimated Expiration: ⤷ Try for Free
Australia
Patent: 09242451
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷ Try for Free
Patent: 10210598
Patent: Tablets for combination therapy
Estimated Expiration: ⤷ Try for Free
Patent: 14221210
Estimated Expiration: ⤷ Try for Free
Patent: 15200637
Patent: TABLETS FOR COMBINATION THERAPY
Estimated Expiration: ⤷ Try for Free
Patent: 16250470
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷ Try for Free
Patent: 17201473
Patent: Tablets for combination therapy
Estimated Expiration: ⤷ Try for Free
Patent: 18267573
Patent: Tablets for combination therapy
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 0911871
Patent: uso de partículas veículo sólidas para melhorar a processabilidade de um agente farmacêutico
Estimated Expiration: ⤷ Try for Free
Patent: 1008664
Patent: comprimidos para a terapia de combinação
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 20856
Patent: UTILISATION DE PARTICULES SUPPORTS SOLIDES POUR AMELIORER L'APTITUDE AU TRAITEMENT D'UN AGENT PHARMACEUTIQUE (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Try for Free
Patent: 50521
Patent: PASTILLES DESTINEES A UNE THERAPIE COMBINEE (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷ Try for Free
Chile
Patent: 11001885
Patent: Tableta bicapa oral en donde la primera capa comprende al compuesto de formula i (elvitegravir) y al compuesto de formula ii, y la segunda capa comprende al compuesto de formula iii (emtricitabina) y a la sal de formula iv (sal de tenofovir); metodo para la preparacion, util en el tratar infecciones por vih.
Estimated Expiration: ⤷ Try for Free
China
Patent: 2123700
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷ Try for Free
Patent: 2307573
Patent: Tablets for combination therapy
Estimated Expiration: ⤷ Try for Free
Patent: 3479584
Patent: Use of solid carrier particles to improve the processability of pharmaceutical agent
Estimated Expiration: ⤷ Try for Free
Patent: 4940937
Patent: The use of solid carrier particles to improve the processability of a pharmaceutical agent
Estimated Expiration: ⤷ Try for Free
Colombia
Patent: 21225
Patent: PARTICULAS PORTADORAS SÓLIDAS PARA MEJORAR LA PROCESABILIDAD DE UN AGENTE FARMACÉUTICO
Estimated Expiration: ⤷ Try for Free
Patent: 00187
Patent: TABLETAS PARA TERAPIA DE COMBINACIÓN
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0151009
Estimated Expiration: ⤷ Try for Free
Patent: 0151357
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 16852
Estimated Expiration: ⤷ Try for Free
Patent: 17067
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 96633
Estimated Expiration: ⤷ Try for Free
Patent: 93485
Estimated Expiration: ⤷ Try for Free
Ecuador
Patent: 10010636
Patent: EL USO DE PARTÍCULAS TRANSPORTADORAS SÓLIDAS PARA MEJORAR LA PROCESABILIDAD DE UN AGENTE FARMACÉUTICO
Estimated Expiration: ⤷ Try for Free
Patent: 11011307
Patent: COMPRIMIDOS PARA TERAPIA DE COMBINACION
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 1313
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷ Try for Free
Patent: 2950
Patent: ПРИМЕНЕНИЕ ЧАСТИЦ НОСИТЕЛЯ ДИОКСИДА КРЕМНИЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА (USE OF SILICON DIOXIDE CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Try for Free
Patent: 0123
Patent: ТАБЛЕТКА ДЛЯ ЛЕЧЕНИЯ ВИЧ И СПОСОБ ЛЕЧЕНИЯ ВИЧ С ЕЕ ПРИМЕНЕНИЕМ (TABLET FOR TREATING HIV AND METHOD OF TREATING HIV USING SAME)
Estimated Expiration: ⤷ Try for Free
Patent: 1071173
Patent: ПРИМЕНЕНИЕ ЧАСТИЦ ТВЁРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА
Estimated Expiration: ⤷ Try for Free
Patent: 1190125
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ
Estimated Expiration: ⤷ Try for Free
Patent: 1491658
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ
Estimated Expiration: ⤷ Try for Free
Patent: 1591353
Patent: ПРИМЕНЕНИЕ ЧАСТИЦ ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 96633
Patent: UTILISATION DE VEHICULES PARTICULAIRES SOLIDES POUR FACILITER LA FORMULATION D'UN AGENT PHARMACEUTIQUE. (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Try for Free
Patent: 93485
Patent: COMPRIMÉ BICOUCHE CONTENANT DE L'ELVITEGRAVIR, DU COBICISTAT, DE L'EMTRICITABINE ET DU TENOFOVIR (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR)
Estimated Expiration: ⤷ Try for Free
Patent: 06032
Patent: UTILISATION DE PARTICULES SUPPORTS SOLIDES POUR AMÉLIORER L'APTITUDE AU TRAITEMENT D'UN AGENT PHARMACEUTIQUE (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 53670
Patent: 利用固體載體顆粒來改進藥劑加工性 (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Try for Free
Patent: 64737
Patent: 包括埃替拉韋, ,恩曲他濱和替諾福韋的雙層片劑 (BILAYER TABLETS COMPRISING ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR COBICISTAT)
Estimated Expiration: ⤷ Try for Free
Patent: 15679
Patent: 固體載體顆粒在改善藥物製劑加工性中的應用 (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 25822
Estimated Expiration: ⤷ Try for Free
Patent: 26380
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 8614
Patent: שימוש בחלקיקי נשא מוצק לשיפור היכולת לעיבוד חומר רוקחי (Use of solid carrier particles to improve the processability of a pharmaceutical agent)
Estimated Expiration: ⤷ Try for Free
Patent: 4227
Patent: טבליות עבור טיפול משולב (Tablets for combination therapy)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 11242
Estimated Expiration: ⤷ Try for Free
Patent: 22213
Estimated Expiration: ⤷ Try for Free
Patent: 11927
Estimated Expiration: ⤷ Try for Free
Patent: 25171
Estimated Expiration: ⤷ Try for Free
Patent: 11522790
Estimated Expiration: ⤷ Try for Free
Patent: 12517432
Estimated Expiration: ⤷ Try for Free
Patent: 14012741
Patent: USE OF SOLID CARRIER PARTICLE TO IMPROVE PROCESSABILITY OF PHARMACEUTICAL AGENT
Estimated Expiration: ⤷ Try for Free
Patent: 14221845
Patent: 併用治療のための錠剤 (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 2377
Patent: USO DE PARTICULAS TRASPORTADORAS SOLIDAS PARA MEJORAR LA CAPACIDAD DE PROCESAMIENTO DE UN AGENTE FARMACEUTICO. (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT.)
Estimated Expiration: ⤷ Try for Free
Patent: 10011963
Patent: USO DE PARTICULAS TRASPORTADORAS SOLIDAS PARA MEJORAR LA CAPACIDAD DE PROCESAMIENTO DE UN AGENTE FARMACEUTICO. (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT.)
Estimated Expiration: ⤷ Try for Free
Patent: 11008289
Patent: TABLETAS PARA TERAPIA COMBINADA. (TABLETS FOR COMBINATION THERAPY.)
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 8978
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷ Try for Free
Patent: 4214
Patent: TABLETS COMPRISING COBICISTAT, ELVITEGRAVIR, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE FOR COMBINATION THERAPY
Estimated Expiration: ⤷ Try for Free
Peru
Patent: 110994
Patent: COMPRIMIDOS ANTIVIRALES QUE COMPRENDEN ELVITEGRAVIR, EMTRICITABINA, DISOPROXIL FUMARATO DE TENOFOVIR Y UN DERIVADO DE TIAZOL
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 96633
Estimated Expiration: ⤷ Try for Free
Patent: 93485
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 96633
Estimated Expiration: ⤷ Try for Free
Patent: 93485
Estimated Expiration: ⤷ Try for Free
San Marino
Patent: 01500266
Patent: COMPRESSE A DOPPIO STRATO COMPRENDENTI ELVITEGRAVIR, COBICISTAT, EMTRICITABINA E TENOFOVIR
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 3544
Patent: TABLETS FOR COMBINATION THERAPY
Estimated Expiration: ⤷ Try for Free
Patent: 0618
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷ Try for Free
Patent: 14007744
Patent: TABLETS FOR COMBINATION THERAPY
Estimated Expiration: ⤷ Try for Free
Patent: 201609006W
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷ Try for Free
Patent: 201706215U
Patent: Tablets for combination therapy
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 96633
Estimated Expiration: ⤷ Try for Free
Patent: 93485
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1008007
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1645759
Estimated Expiration: ⤷ Try for Free
Patent: 1659971
Estimated Expiration: ⤷ Try for Free
Patent: 1738325
Estimated Expiration: ⤷ Try for Free
Patent: 1784647
Estimated Expiration: ⤷ Try for Free
Patent: 110015581
Patent: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT
Estimated Expiration: ⤷ Try for Free
Patent: 110122729
Patent: TABLETS FOR COMBINATION THERAPY
Estimated Expiration: ⤷ Try for Free
Patent: 160093100
Patent: 조합 요법용 정제 (TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷ Try for Free
Patent: 160114728
Patent: 제약 제제의 가공성 향상을 위한 고체 담체 입자의 용도 (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 48886
Estimated Expiration: ⤷ Try for Free
Patent: 53897
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 44367
Estimated Expiration: ⤷ Try for Free
Patent: 1040142
Patent: Tablets for combination therapy
Estimated Expiration: ⤷ Try for Free
Ukraine
Patent: 1193
Patent: ПРИМЕНЕНИЕ ЧАСТИЧЕК ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА;ЗАСТОСУВАННЯ ЧАСТИНОК ТВЕРДОГО НОСІЯ ДЛЯ ПОЛІПШЕННЯ ТЕХНОЛОГІЧНИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧНОГО АГЕНТА (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Estimated Expiration: ⤷ Try for Free
Patent: 3224
Patent: ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ;ТАБЛЕТКИ ДЛЯ КОМБІНОВАНОЇ ТЕРАПІЇ (Normal;heading 1;heading 2;heading 3;TABLETS FOR COMBINATION THERAPY)
Estimated Expiration: ⤷ Try for Free
Uruguay
Patent: 424
Patent: COMPRIMIDOS CONTENIENDO ELIVITEGRAVIR PARA TRATAMIENTO DE INFECCIONES VIRALES
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TYBOST around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 2487163 | ⤷ Try for Free | |
South Korea | 101659971 | ⤷ Try for Free | |
Croatia | P20200349 | ⤷ Try for Free | |
New Zealand | 579802 | Compounds for improving the efficacy of other drugs | ⤷ Try for Free |
Denmark | 2487163 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TYBOST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3150586 | 18/2020 | Austria | ⤷ Try for Free | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT, UND EMTRICITABIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170925 |
3150586 | LUC00156 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925 |
2049506 | 262 5024-2015 | Slovakia | ⤷ Try for Free | PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM; REGISTRATION NO/DATE: EU/1/13/830 20130527 |
2487166 | 2017003 | Norway | ⤷ Try for 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 |
2487163 | 2016C/066 | Belgium | ⤷ Try for Free | PRODUCT NAME: COBICISTAT ET ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025 20150715 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for TYBOST
More… ↓