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-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, Leading, Rhodes Pharms, Teva Pharms Inc, Medicis, and Novartis, and is included in one hundred and twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for theophylline

US Patents:	0
Tradenames:	52
Applicants:	53
NDAs:	121
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	170
Clinical Trials:	111
Patent Applications:	6,795
Formulation / Manufacturing:	see details
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
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lannett	LANOPHYLLIN	theophylline	ELIXIR;ORAL	084578-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Amneal	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	216276-002	Mar 20, 2023	AB	RX	No	No
Ortho Mcneil Pharm	THEOPHYL-225	theophylline	TABLET;ORAL	084726-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharm Assoc	THEOPHYLLINE	theophylline	SOLUTION, ELIXIR;ORAL	206344-001	Dec 16, 2016	AA	RX	No	No
Cent Pharms	THEOCLEAR-200	theophylline	TABLET;ORAL	085353-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	SLO-BID	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	087893-001	Jan 31, 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