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, Amneal, Aspiro, Avet Lifesciences, Dr Reddys, Hikma, Hospira, Innopharma, Sagent Pharms Inc, Teva Parenteral, and Watson Labs Inc, and is included in eleven 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:	11
NDAs:	11
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	1,914
Patent Applications:	6,595
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
University of Alabama at Birmingham	Phase 1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	N/A
Assiut University	Phase 3

See all propofol clinical trials

Generic filers with tentative approvals for PROPOFOL

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG/ML	INJECTABLE; INJECTION
⤷ Sign Up	⤷ Sign Up	10MG/ML	INJECTABLE; INJECTION
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for propofol

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

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
Sagent Pharms Inc	PROPOFOL	propofol	INJECTABLE;INJECTION	075102-001	Jan 4, 1999	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Innopharma	PROPOFOL	propofol	INJECTABLE;INJECTION	205576-001	Sep 16, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	PROPOFOL	propofol	INJECTABLE;INJECTION	205067-001	Nov 15, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	PROPOFOL	propofol	INJECTABLE;INJECTION	077908-001	Mar 17, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Amneal	PROPOFOL	propofol	INJECTABLE;INJECTION	217525-001	Aug 15, 2024	AB	RX	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

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	⤷ Sign Up	⤷ Sign Up
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	⤷ Sign Up	⤷ Sign Up
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	⤷ Sign Up	⤷ Sign Up
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	⤷ Sign Up	⤷ Sign Up
>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		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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