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Last Updated: June 30, 2022

Aminophylline - Generic Drug Details

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

Aminophylline is the generic ingredient in nine branded drugs marketed by Fisons, Gd Searle Llc, Abraxis Pharm, Am Regent, Elkins Sinn, Hospira, Intl Medication, King Pharms, Luitpold, Lyphomed, Pharma Serve Ny, Smith And Nephew, Teva Parenteral, Morton Grove, Roxane, Actavis Mid Atlantic, Cosette, Impax Labs, Tablicaps, Vale, Pharm Res Assoc, Ani Pharms, Ascot, Barr, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Kv Pharm, Lannett, Pal Pak, Panray, Purepac Pharm, Valeant Pharm Intl, Vangard, Vintage Pharms, and Watson Labs, and is included in sixty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for aminophylline. Five suppliers are listed for this compound.

Summary for aminophylline

US Patents:	0
Tradenames:	9
Applicants:	36
NDAs:	66
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	29
Patent Applications:	6,723
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in aminophylline?	aminophylline excipients list
DailyMed Link:	aminophylline at DailyMed

Recent Clinical Trials for aminophylline

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

Sponsor	Phase
Sengkang General Hospital	Phase 2
Singapore General Hospital	Phase 2
Beni-Suef University	Phase 1

See all aminophylline clinical trials

Pharmacology for aminophylline

Drug Class	Methylxanthine

Medical Subject Heading (MeSH) Categories for aminophylline

Bronchodilator Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for aminophylline

R03DA	Xanthines
R03D	OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for aminophylline

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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	AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%	aminophylline	INJECTABLE;INJECTION	088147-003	May 3, 1983		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Roxane	AMINOPHYLLINE	aminophylline	TABLET;ORAL	087500-001	Feb 9, 1982		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Impax Labs	AMINOPHYLLINE	aminophylline	TABLET;ORAL	084576-001	Approved Prior to Jan 1, 1982		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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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