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Last Updated: October 29, 2020

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Theophylline - Generic Drug Details

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What are the generic sources for theophylline and what is the scope of patent protection?

Theophylline is the generic ingredient in fifty-two branded drugs marketed by Fleming Pharms, Forest Labs, Sanofi Aventis Us, Graham Dm, Actient Pharms, Auxilium Pharms Inc, Auxilium Pharms Llc, Schering, Whitby, Schwarz Pharma, Ortho Mcneil Pharm, Cent Pharms, Hospira, Inwood Labs, Sandoz, Scherer Rp, Fisons, Kv Pharm, Cenci, Lannett, Panray, Alpharma Us Pharms, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Taro, Wockhardt, B Braun, Baxter Hlthcare, Hospira Inc, Nostrum Labs Inc, 3M, Lannett Co Inc, Tris Pharma Inc, Ferndale Labs, Warner Chilcott, Monarch Pharms, Roerig, Pharm Res Assoc, Nostrum Pharms Llc, Able, Alembic Pharms Ltd, Glenmark Generics, Heritage Pharma, Rhodes Pharms, Medicis, and Novartis, and is included in one hundred and sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for theophylline. Fifteen suppliers are listed for this compound.

Drug Prices for theophylline

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Drug Sales Revenue Trends for theophylline

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Recent Clinical Trials for theophylline

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SponsorPhase
Assiut UniversityEarly Phase 1
Ashley ShoemakerPhase 2
University of California, Los AngelesEarly Phase 1

See all theophylline clinical trials

Pharmacology for theophylline
Drug ClassMethylxanthine

US Patents and Regulatory Information for theophylline

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Pharm THEOPHYL-225 theophylline TABLET;ORAL 084726-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Cenci ELIXOMIN theophylline ELIXIR;ORAL 088303-001 Jan 25, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us SLO-BID theophylline CAPSULE, EXTENDED RELEASE;ORAL 087892-001 Jan 31, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 018649-006 Nov 13, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
>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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