Sodium benzoate; sodium phenylacetate - Generic Drug Details

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What are the generic sources for sodium benzoate; sodium phenylacetate and what is the scope of patent protection?

Sodium benzoate; sodium phenylacetate is the generic ingredient in three branded drugs marketed by Bausch, Ailex Pharms Llc, Maia Pharms Inc, Navinta Llc, and B Braun, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Sponsor	Phase
Takeda	Phase 1
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 2
Ucyclyd Pharma, Inc.	Phase 1

Sponsor

Phase

Takeda

Phase 1

Horizon Pharma Ireland, Ltd., Dublin Ireland

Phase 2

Ucyclyd Pharma, Inc.

Phase 1

US Patents and Regulatory Information for sodium benzoate; sodium phenylacetate

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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	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	215025-001	Jun 10, 2021	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Navinta Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	217526-001	Jul 14, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ailex Pharms Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	207096-001	Feb 24, 2016	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Maia Pharms Inc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	208521-001	May 8, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	AMMONUL	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	020645-001	Feb 17, 2005		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
B Braun	UCEPHAN	sodium benzoate; sodium phenylacetate	SOLUTION;ORAL	019530-001	Dec 23, 1987		DISCN	No	No	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
B Braun	UCEPHAN	sodium benzoate; sodium phenylacetate	SOLUTION;ORAL	019530-001	Dec 23, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Applicant

Tradename

Generic Name

Dosage

NDA

Approval Date

Patent No.

Patent Expiration

B Braun

UCEPHAN

sodium benzoate; sodium phenylacetate

SOLUTION;ORAL

019530-001

Dec 23, 1987

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>Applicant

>Tradename

>Generic Name

>Dosage

>NDA

>Approval Date

>Patent No.

>Patent Expiration

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US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	4
Patent Applications:	2
DailyMed Link:	sodium benzoate; sodium phenylacetate at DailyMed

Drug Class	Nitrogen Binding Agent
Mechanism of Action	Ammonium Ion Binding Activity

Sodium benzoate; sodium phenylacetate - Generic Drug Details

What are the generic sources for sodium benzoate; sodium phenylacetate and what is the scope of patent protection?

Summary for sodium benzoate; sodium phenylacetate

Recent Clinical Trials for sodium benzoate; sodium phenylacetate

Pharmacology for sodium benzoate; sodium phenylacetate

Anatomical Therapeutic Chemical (ATC) Classes for sodium benzoate; sodium phenylacetate

US Patents and Regulatory Information for sodium benzoate; sodium phenylacetate

Expired US Patents for sodium benzoate; sodium phenylacetate

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