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Last Updated: April 19, 2024

Propofol - Generic Drug Details

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

Propofol is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Avet Lifesciences, Dr Reddys, Hikma, Hospira, Innopharma, Sagent Pharms Inc, Teva Parenteral, and Watson Labs Inc, and is included in nine NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Propofol has one patent family member in one country.

There are twelve drug master file entries for propofol. Eleven suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for propofol

International Patents:	1
US Patents:	1
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	1,872
Patent Applications:	6,669
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for propofol
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for propofol
What excipients (inactive ingredients) are in propofol?	propofol excipients list
DailyMed Link:	propofol at DailyMed

See drug prices for propofol

Recent Clinical Trials for propofol

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

Sponsor	Phase
Children's Hospital of Fudan University	N/A
Arkansas Children's Hospital Research Institute	Phase 4
National Trauma Center	N/A

See all propofol clinical trials

Generic filers with tentative approvals for PROPOFOL

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	10MG/ML	INJECTABLE; INJECTION
⤷ Try a Trial	⤷ Try a Trial	10MG/ML	INJECTABLE; INJECTION
⤷ Try a Trial	⤷ Try a Trial	10MG/ML	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for propofol

Drug Class	General Anesthetic
Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for propofol

Anesthetics, Intravenous
Hypnotics and Sedatives

US Patents and Regulatory Information for propofol

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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
Hikma	PROPOFOL	propofol	INJECTABLE;INJECTION	074848-001	Apr 19, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-001	Oct 2, 1989		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Avet Lifesciences	PROPOFOL	propofol	INJECTABLE;INJECTION	206408-001	Oct 12, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 propofol

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	⤷ Try a Trial	⤷ Try a Trial
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	⤷ Try a Trial	⤷ Try a Trial
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for propofol

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005007131		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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