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Last Updated: September 21, 2021

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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, 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, Glenmark Pharms Ltd, Heritage Pharma, Rhodes Pharms, Medicis, and Novartis, and is included in one hundred and seventeen 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:	50
NDAs:	117
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	101
Patent Applications:	6,160
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

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
Novartis Pharmaceuticals	Phase 2
Hospital Israelita Albert Einstein	Phase 4
Industria Farmacêutica Health Meds	Phase 4

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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Glossary

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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
Pharm Assoc	THEOPHYLLINE	theophylline	SOLUTION, ELIXIR;ORAL	206344-001	Dec 16, 2016	AA	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Wockhardt	THEOPHYLLINE	theophylline	ELIXIR;ORAL	086748-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Nostrum Pharms Llc	THEOCHRON	theophylline	TABLET, EXTENDED RELEASE;ORAL	087400-003	Feb 21, 1985	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Hospira Inc	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	019211-002	Dec 14, 1984		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
>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	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.