BELINOSTAT - Generic Drug Details

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What are the generic drug sources for belinostat and what is the scope of patent protection?

Belinostat is the generic ingredient in one branded drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Belinostat has fifty-nine patent family members in twenty-seven countries.

There are five drug master file entries for belinostat. One supplier is listed for this compound.

Summary for BELINOSTAT

International Patents:	59
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	55
Patent Applications:	4,907
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BELINOSTAT
What excipients (inactive ingredients) are in BELINOSTAT?	BELINOSTAT excipients list
DailyMed Link:	BELINOSTAT at DailyMed

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

Generic Entry Date for BELINOSTAT^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 BELINOSTAT

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

Sponsor	Phase
Acrotech Biopharma Inc.	Phase 3
Pfizer	Phase 2
Acrotech Biopharma	Phase 2

See all BELINOSTAT clinical trials

Pharmacology for BELINOSTAT

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BELINOSTAT

L01XH	Histone deacetylase (HDAC) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BELINOSTAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELEODAQ	Injection	belinostat	500 mg/vial	206256	1	2018-07-03

US Patents and Regulatory Information for BELINOSTAT

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256-001	Jul 3, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256-001	Jul 3, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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 BELINOSTAT

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Country	Patent Number	Title	Estimated Expiration
Israel	187231	הרכבים רוקחיים הכוללים מעכב היסטון דה-אצטילז וארגינין חופשי או מלח שלו, שימוש בהם ומוצרים המכילים אותם (Pharmaceutica l compositions of a histone deacetylase (hdac) inhibitor and free arginine or salt thereof' use thereof and products containing the same)	⤷ Sign Up
Portugal	1328510		⤷ Sign Up
Poland	1901729		⤷ Sign Up
Israel	224229	תכשיר רוקחי המכיל מעכב היסטון דה-אצטילז ומגלומין ושימוש בו ליצור תרופה (Pharmaceutical composition comprising a histone deacetylase inhibitor and meglumine and uses thereof in the manufacture of a medicament)	⤷ Sign Up
Ecuador	SP078002	FORMULACIONES FARMACEUTICAS DE INHIBIDORES DE HDAC	⤷ Sign Up
European Patent Office	1901729	FORMULATIONS PHARMACEUTIQUES D'INHIBITEURS DE HDAC (PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS)	⤷ Sign Up
Eurasian Patent Organization	201370122	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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