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Last Updated: September 30, 2022

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, Glenmark Pharms Ltd, Heritage Pharma Avet, Rhodes Pharms, Medicis, and Novartis, and is included in one hundred and seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for theophylline. Twelve 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
University of California, Los AngelesEarly Phase 1
Sengkang General HospitalPhase 2
University of ArkansasPhase 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
Schering THEO-DUR theophylline CAPSULE, EXTENDED RELEASE;ORAL 088016-001 Sep 10, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
B Braun THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 019212-001 Nov 7, 1984 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Forest Labs DURAPHYL theophylline TABLET, EXTENDED RELEASE;ORAL 088505-001 Apr 3, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ortho Mcneil Pharm THEOPHYL-225 theophylline TABLET;ORAL 084726-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us SLO-BID theophylline CAPSULE, EXTENDED RELEASE;ORAL 087894-001 Jan 31, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Baxter Hlthcare THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 018649-005 Jul 26, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Schering THEO-DUR theophylline TABLET, EXTENDED RELEASE;ORAL 086998-001 Approved Prior to Jan 1, 1982 DISCN Yes 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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Serving leading biopharmaceutical companies globally:

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Medtronic
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.