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Last Updated: November 22, 2024

AMINOPHYLLINE - Generic Drug Details


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What are the generic drug 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, Chartwell Molecular, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Kv Pharm, 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. Four 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: 4
Raw Ingredient (Bulk) Api Vendors: 82
Clinical Trials: 38
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

SponsorPhase
Mahidol UniversityPhase 2/Phase 3
Medical College of WisconsinPhase 1/Phase 2
University of OklahomaPhase 1/Phase 2

See all AMINOPHYLLINE clinical trials

Pharmacology for AMINOPHYLLINE
Drug ClassMethylxanthine

US Patents and Regulatory Information for AMINOPHYLLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira AMINOPHYLLINE aminophylline INJECTABLE;INJECTION 087242-001 Oct 26, 1983 RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms AMINOPHYLLINE aminophylline TABLET;ORAL 085261-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs AMINOPHYLLINE aminophylline TABLET, DELAYED RELEASE;ORAL 084575-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Roxane AMINOPHYLLINE aminophylline TABLET;ORAL 087501-001 Feb 9, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ascot AMINOPHYLLINE aminophylline TABLET;ORAL 087522-001 Feb 12, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER aminophylline INJECTABLE;INJECTION 018924-004 Dec 12, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER aminophylline INJECTABLE;INJECTION 018924-003 Dec 12, 1984 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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