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Last Updated: October 23, 2021

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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, Glenmark Pharms Ltd, Heritage Pharma, 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. 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novartis PharmaceuticalsPhase 2
Industria FarmacĂȘutica Health MedsPhase 4
Hospital Israelita Albert EinsteinPhase 4

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
Cent Pharms THEOCLEAR-100 theophylline TABLET;ORAL 085353-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hospira THEOPHYLLINE theophylline CAPSULE, EXTENDED RELEASE;ORAL 089976-001 Jan 4, 1995 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Auxilium Pharms Llc THEO-24 theophylline CAPSULE, EXTENDED RELEASE;ORAL 087943-001 Aug 22, 1983 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Glenmark Generics THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 090355-001 Jul 13, 2010 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Baxter Hlthcare THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 018649-006 Nov 13, 1985 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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:

Mallinckrodt
McKinsey
Boehringer Ingelheim
Merck
Moodys
Baxter

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