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Last Updated: November 21, 2024

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, 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, Rhodes Pharms, Strides Pharma, Teva Pharms Inc, Velzen Pharma Pvt, Zydus Lifesciences, Medicis, and Novartis, and is included in one hundred and twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for theophylline. Twenty-six suppliers are listed for this compound.

Summary for theophylline

US Patents:	0
Tradenames:	52
Applicants:	55
NDAs:	123
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	170
Clinical Trials:	111
Patent Applications:	6,799
Drug Prices:	Drug price trends for theophylline
What excipients (inactive ingredients) are in theophylline?	theophylline excipients list
DailyMed Link:	theophylline at DailyMed

Drug Prices for theophylline

See drug prices for theophylline

Drug Sales Revenue Trends for theophylline

See drug sales revenues for theophylline

Recent Clinical Trials for theophylline

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

Sponsor	Phase
Tanta University	N/A
LG Chem	Phase 1
University of Oklahoma	Phase 1/Phase 2

See all theophylline clinical trials

Pharmacology for theophylline

Drug Class	Methylxanthine

Medical Subject Heading (MeSH) Categories for theophylline

Bronchodilator Agents
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for theophylline

R03DA	Xanthines
R03D	OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for theophylline

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nostrum Pharms Llc	THEOCHRON	theophylline	TABLET, EXTENDED RELEASE;ORAL	087400-005	Aug 9, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharma Avet	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	081236-001	Nov 9, 1992	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	ASBRON	theophylline sodium glycinate	TABLET;ORAL	085148-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	SLO-BID	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	087893-001	Jan 31, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
B Braun	THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	019083-003	Nov 7, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Medicis	THEOLAIR	theophylline	TABLET;ORAL	086399-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharma Avet	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	089808-001	Apr 30, 1990		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

Expired US Patents for theophylline

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Monarch Pharms	QUIBRON-T/SR	theophylline	TABLET, EXTENDED RELEASE;ORAL	087563-001	Jun 21, 1983	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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