Theophylline - Generic Drug Details

What are the generic sources for theophylline and what is the scope of freedom to operate?

Theophylline is the generic ingredient in fifty-one 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, Sun Pharma Canada, Wockhardt, B Braun, Baxter Hlthcare, Hospira Inc, Solis Pharms, 3M, Chartwell Molecular, Tris Pharma Inc, Ferndale Labs, Warner Chilcott, Monarch Pharms, Roerig, Pharm Res Assoc, Able, Ajanta Pharma Ltd, Alembic, Amneal, Annora Pharma, Bionpharma, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Mpp Pharma, Nostrum Pharms Llc, Rhodes Pharms, Strides Pharma, Teva Pharms Inc, Velzen Pharma Pvt, Zydus Lifesciences, Medicis, and Novartis, and is included in one hundred and twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for theophylline

US Patents:	0
Tradenames:	51
Applicants:	57
NDAs:	124
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	122
Patent Applications:	6,198
Drug Prices:	Drug price trends for theophylline
What excipients (inactive ingredients) are in theophylline?	theophylline excipients list
DailyMed Link:	theophylline at DailyMed

See drug prices for theophylline

See drug sales revenues for theophylline

Recent Clinical Trials for theophylline

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

Sponsor	Phase
University of Nebraska	PHASE1
Minia University	EARLY_PHASE1
Assiut University	PHASE1

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	UNI-DUR	theophylline	TABLET, EXTENDED RELEASE;ORAL	089823-001	Jan 4, 1995		DISCN	No	No
Sanofi Aventis Us	SLO-PHYLLIN	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	085206-001	May 24, 1982		DISCN	No	No
Alpharma Us Pharms	THEOPHYLLINE	theophylline	ELIXIR;ORAL	089223-001	May 27, 1988		DISCN	No	No
Graham Dm	SOMOPHYLLIN-CRT	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	087763-001	Feb 27, 1985		DISCN	No	No
Sanofi Aventis Us	ACCURBRON	theophylline	SYRUP;ORAL	088746-001	Nov 22, 1985		DISCN	No	No

Expired US Patents for theophylline

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