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Last Updated: July 5, 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 freedom to operate?

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. Fourteen 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

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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
Able THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 040543-001 Apr 27, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us SLO-PHYLLIN theophylline CAPSULE, EXTENDED RELEASE;ORAL 085205-001 May 24, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Ortho Mcneil Pharm THEOPHYL-225 theophylline ELIXIR;ORAL 086485-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Rhodes Pharms THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 040086-002 Sep 1, 1982 AB RX No No   Start Trial   Start Trial   Start Trial
Hospira THEOPHYLLINE theophylline CAPSULE, EXTENDED RELEASE;ORAL 089977-001 Jan 4, 1995 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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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Moodys
Harvard Business School
Medtronic
Dow

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