SINCALIDE - Generic Drug Details

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What are the generic sources for sincalide and what is the scope of freedom to operate?

Sincalide is the generic ingredient in two branded drugs marketed by Bracco and Maia Pharms Inc, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sincalide has three patent family members in three countries.

There are three drug master file entries for sincalide. Four suppliers are listed for this compound.

Summary for SINCALIDE

International Patents:	3
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	4
Patent Applications:	2,661
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SINCALIDE
What excipients (inactive ingredients) are in SINCALIDE?	SINCALIDE excipients list
DailyMed Link:	SINCALIDE at DailyMed

Recent Clinical Trials for SINCALIDE

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3
Penn State University	N/A

See all SINCALIDE clinical trials

Pharmacology for SINCALIDE

Drug Class	Cholecystokinin Analog

Anatomical Therapeutic Chemical (ATC) Classes for SINCALIDE

V04CC	Tests for bile duct patency
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for SINCALIDE

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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
Maia Pharms Inc	SINCALIDE	sincalide	POWDER;INTRAVENOUS	210850-001	Nov 22, 2022	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Maia Pharms Inc	SINCALIDE	sincalide	POWDER;INTRAVENOUS	210850-001	Nov 22, 2022	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for SINCALIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for SINCALIDE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019040904		⤷ Sign Up
European Patent Office	3672616	FORMULES DE SINCALIDE STABLES AU STOCKAGE (STORAGE STABLE SINCALIDE FORMULATIONS)	⤷ Sign Up
Canada	3073944	FORMULES DE SINCALIDE STABLES AU STOCKAGE (STORAGE STABLE SINCALIDE FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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