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Last Updated: July 9, 2020

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THEOPHYLLINE Drug Profile


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Which patents cover Theophylline, and what generic alternatives are available?

Theophylline is a drug marketed by Cent Pharms, Hospira, Inwood Labs, Sandoz, Kv Pharm, Scherer Rp, Alpharma Us Pharms, Cenci, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Taro, Wockhardt, Lannett Co Inc, Tris Pharma Inc, Able, Alembic Pharms Ltd, Glenmark Generics, Heritage Pharma, Nostrum Labs Inc, Rhodes Pharms, B Braun, Baxter Hlthcare, and Hospira Inc. and is included in forty-three NDAs.

The generic ingredient in THEOPHYLLINE is theophylline. There are thirty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the theophylline profile page.

US ANDA Litigation and Generic Entry Outlook for Theophylline

A generic version of THEOPHYLLINE was approved as theophylline by RHODES PHARMS on September 1st, 1982.

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Drug patent expirations by year for THEOPHYLLINE
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
Hospira Inc THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 019211-006 Jan 20, 1988 DISCN Yes No   Start Trial   Start Trial   Start Trial
Heritage Pharma THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 089763-001 Apr 30, 1990 AB RX No No   Start Trial   Start Trial   Start Trial
Able THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 040543-001 Apr 27, 2004 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:

Moodys
Express Scripts
Merck
AstraZeneca
McKesson
Mallinckrodt

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