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Last Updated: June 23, 2024

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, Endo Operations, 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, Chartwell Molecular, Tris Pharma Inc, Ferndale Labs, Warner Chilcott, Monarch Pharms, Roerig, Pharm Res Assoc, Nostrum Pharms Llc, Able, Alembic, Amneal, Annora Pharma, Bionpharma, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Leading, Rhodes Pharms, Teva Pharms Inc, Medicis, and Novartis, and is included in one hundred and twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for theophylline. Twenty-one 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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University of OklahomaPhase 1/Phase 2
Medical College of WisconsinPhase 1/Phase 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
Sanofi Aventis Us SLO-BID theophylline CAPSULE, EXTENDED RELEASE;ORAL 089539-001 May 10, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us SLO-BID theophylline CAPSULE, EXTENDED RELEASE;ORAL 087894-001 Jan 31, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
B Braun THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 019826-002 Aug 14, 1992 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us SLO-PHYLLIN theophylline TABLET;ORAL 085204-001 Approved Prior to Jan 1, 1982 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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