Alfentanil hydrochloride - Generic Drug Details

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

Alfentanil hydrochloride is the generic ingredient in two branded drugs marketed by Rising and Hospira, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for alfentanil hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for alfentanil hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	50
Patent Applications:	532
What excipients (inactive ingredients) are in alfentanil hydrochloride?	alfentanil hydrochloride excipients list
DailyMed Link:	alfentanil hydrochloride at DailyMed

Recent Clinical Trials for alfentanil hydrochloride

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A
Region Jönköping County	Phase 4
Region Östergötland	Phase 4

See all alfentanil hydrochloride clinical trials

Generic filers with tentative approvals for ALFENTANIL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 0.5MG BASE/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 alfentanil hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for alfentanil hydrochloride

Analgesics, Opioid
Anesthetics, Intravenous
Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for alfentanil hydrochloride

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for alfentanil hydrochloride

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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
Hospira	ALFENTANIL	alfentanil hydrochloride	INJECTABLE;INJECTION	075221-001	Oct 28, 1999	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	ALFENTA	alfentanil hydrochloride	INJECTABLE;INJECTION	019353-001	Dec 29, 1986	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 alfentanil hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	ALFENTA	alfentanil hydrochloride	INJECTABLE;INJECTION	019353-001	Dec 29, 1986	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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