DrugPatentWatch Database Preview

Theophylline - Generic Drug Details

« Back to Dashboard

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, Heritage Pharma, Rhodes Pharms, Medicis, and Novartis, and is included in one hundred and sixteen 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.

Summary for theophylline

US Patents:	0
Tradenames:	52
Applicants:	49
NDAs:	116
Drug Master File Entries:	36
Suppliers / Packagers:	14
Bulk Api Vendors:	125
Clinical Trials:	95
Patent Applications:	8,902
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for theophylline
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
Assiut University	Early Phase 1
Ashley Shoemaker	Phase 2
University of California, Los Angeles	Early Phase 1

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

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
Able	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	040543-001	Apr 27, 2004		DISCN	No	No
Sanofi Aventis Us	SLO-PHYLLIN	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	085205-001	May 24, 1982		DISCN	No	No
Ortho Mcneil Pharm	THEOPHYL-225	theophylline	ELIXIR;ORAL	086485-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Rhodes Pharms	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	040086-002	Sep 1, 1982	AB	RX	No	No
Hospira	THEOPHYLLINE	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	089977-001	Jan 4, 1995		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