Trilaciclib dihydrochloride - Generic Drug Details

What are the generic drug sources for trilaciclib dihydrochloride and what is the scope of freedom to operate?

Trilaciclib dihydrochloride is the generic ingredient in one branded drug marketed by G1 Therap and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trilaciclib dihydrochloride has one hundred and thirty-five patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for trilaciclib dihydrochloride

International Patents:	135
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	20
DailyMed Link:	trilaciclib dihydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for trilaciclib dihydrochloride

Dosage:

POWDER;INTRAVENOUS

^*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 trilaciclib dihydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Phase 2
Wake Forest University Health Sciences	Phase 2
Merck Sharp & Dohme LLC	Phase 2

See all trilaciclib dihydrochloride clinical trials

Pharmacology for trilaciclib dihydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Cyclin-dependent Kinase 4 Inhibitors Cyclin-dependent Kinase 6 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for trilaciclib dihydrochloride

V03AF	Detoxifying agents for antineoplastic treatment
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for trilaciclib dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes				Y
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes			Y
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes			Y
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes			Y	Y

International Patents for trilaciclib dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2019120160	СОХРАНЕНИЕ ИММУННОГО ОТВЕТА ВО ВРЕМЯ ХИМИОТЕРАПЕВТИЧЕСКИХ СХЕМ
Canada	2906166	TRAITEMENTS EPARGNANT HSPC POUR LA PROLIFERATION CELLULAIRE ANORMALE RB POSITIVE (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION)
World Intellectual Property Organization (WIPO)	2014144740
Slovenia	2968290
Japan	2016518337	高活性抗新生物薬及び抗増殖剤
China	105473140	Transient protection of normal cells during chemotherapy
South Korea	20240023676	화학요법 레지멘 동안의 면역 반응의 보존 (PRESERVATION OF IMMUNE RESPONSE DURING CHEMOTHERAPY REGIMENS)