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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, Heritage Pharma, Mylan Ireland Ltd, 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. Nineteen suppliers are listed for this compound.

Summary for theophylline

US Patents:	0
Tradenames:	52
Applicants:	50
NDAs:	117
Drug Master File Entries:	36
Suppliers / Packagers:	19
Bulk Api Vendors:	118
Clinical Trials:	90
Patent Applications:	6,712
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
Johns Hopkins University	Phase 3
Beni-Suef University	Phase 1
Genentech, Inc.	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

Synonyms for theophylline

(8alpha, 9S)-10,11-Dihydro-6'-methoxycinchonan-9-amine trihydrochloride, min. 90%

0I55128JYK

1,3-dimethyl-1,3,7-trihydropurine-2,6-dione

1,3-dimethyl-1H-purine-2,6(3H,7H)-dione

1,3-dimethyl-1H-purine-2,6(3H,9H)-dione

1,3-dimethyl-2,3,6,7-tetrahydro-1H-purine-2,6-dione

1,3-Dimethyl-2,6-dioxo-1,2,3,6-tetrahydropurine

1,3-Dimethyl-2,6-dioxo-1,2,3,6-tetrahydropurine; 1,3-Dimethylxanthine; 3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione

1,3-Dimethyl-3,7-dihydro-1H-purine-2,6-dione

1,3-Dimethyl-3,7-dihydro-1H-purine-2,6-dione #

1,3-dimethyl-3,9-dihydro-1H-purine-2,6-dione

1,3-Dimethyl-6-hydroxy-1,3-dihydro-2H-purin-2-one

1,3-dimethyl-7H-purine-2,6-dione

1,3-Dimethylxanthine

1024160-72-2

111079-49-3

1H-Purine-2, 3,7-dihydro-1,3-dimethyl-

1H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-

1H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, mo

1H-Purine-2,6-dione, 3,9-dihydro-1,3-dimethyl-

2,6-Dihydroxy-1,3-dimethylpurine

2a3a

3,7-dihydro-1,3-dimethyl-1H- purine-2,6-dione

3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione

46157-00-0

4eoh

56645-32-0

58-55-9

6461-EP1441224A2

6461-EP2272835A1

6461-EP2272841A1

6461-EP2272844A1

6461-EP2280006A1

6461-EP2281813A1

6461-EP2281815A1

6461-EP2286811A1

6461-EP2295434A2

6461-EP2298305A1

6461-EP2301933A1

6461-EP2301936A1

6461-EP2301937A1

6461-EP2305219A1

6461-EP2305640A2

6461-EP2308562A2

6461-EP2311827A1

6461-EP2314590A1

75448-53-2

8-(2-Furyl)theophylline

83377-EP2371823A1

A3133D49-AAB6-49A1-B60B-B5198F327D3F

AB00052106

AB00052106_24

AB00052106_25

AB00052106_26

AB00052106-20

AB00052106-22

AB00052106-23

AB1009249

AC-20328

AC1L1D1F

Accurbron

Acet-theocin

Aerobin

Aerolate

Aerolate III

Aerolate SR

Aescin-IIA

Afonilm

Afonilum

Afonilum Retard

AI3-50216

AKOS000120961

AKOS005434016

AN-23602

Aquaphyllin

Armophylline

ARONIS25346

Asbron

Asmalix

Asmax

Austyn

BBL023514

BCBcMAP01_000071

BDBM10847

BDBM82053

BIDD:ER0557

BIDD:GT0151

Bilordyl

BPBio1_000791

BPBio1_001041

BRD-K97799481-001-02-0

BRD-K97799481-001-12-9

BRD-K97799481-002-03-6

Bronchodid Duracap

Bronchoretard

Bronkodyl

Bronkodyl SR

Bronkotabs

BSPBio_000719

BSPBio_000945

BSPBio_002363

C07130

C7H8N4O2

CAS-58-55-9

CCG-20301

CCRIS 4729

Cetraphylline

CHEBI:28177

CHEMBL190

Choledyl SA

Chronophyllin

component of Bronkotabs (Salt/Mix)

component of Dicurin Procaine

component of Dicurin Procaine (Salt/Mix)

component of Hecadrol (Salt/Mix)

component of Mudrane GG elixir (Salt/Mix)

component of Primatene

component of Primatene (Salt/Mix)

component of Primatene tablets (Salt/Mix)

component of Quibron (Salt/Mix)

component of Quibron Plus (Salt/Mix)

component of Quibron-T/SR (Salt/Mix)

component of Slo-phyllin GG (Salt/Mix)

component of Tedral (Salt/Mix)

component of Theo-organdin (Salt/Mix)

component of Theo-Organidin

component of Theo-Organidin (Salt/Mix)

component of Theolair plus (Salt/Mix)

Constant T

Constant-T

CPD000058537

CS-4158

CTK3J1985

D00371

DB-053224

DB00277

Diffumal

Dimethylxanthine

DivK1c_000203

Doraphyllin

DSSTox_CID_1336

DSSTox_GSID_21336

DSSTox_RID_76090

DTXSID5021336

Duraphyl

Duraphyllin

EC 200-385-7

Egifilin

EINECS 200-385-7

Elixex

Elixicon

Elixomin

Elixophyllin

Elixophyllin (TN)

Elixophyllin SR

Elixophyllin(e)

Elixophylline

Etheophyl

Euphyllin

Euphylline

Euphylong

F2173-0145

FT-0631259

Glycine Theophyllinate

GS 2591A

GTPL413

HMS1921E03

HMS2089A06

HMS2092M05

HMS2233E16

HMS3259O06

HMS3369N14

HMS500K05

HSDB 3399

HY-B0809

Hylate

I14-16783

IDI1_000203

InChI=1/C7H8N4O2/c1-10-5-4(8-3-9-5)6(12)11(2)7(10)13/h3H,1-2H3,(H,8,9

KBio1_000203

KBio2_001518

KBio2_004086

KBio2_006654

KBio3_001583

KBioGR_000785

KBioSS_001518

KS-000010T0

KS-0000477R

KSC491S8L

L000595

LaBID

Labophylline

Lanophyllin

LASMA

Liquophylline

Lopac0_000014

LS-241

Maphylline

MCULE-8236489917

Medaphyllin

MFCD00079619

MLS000069390

MLS002152943

MLS002153487

MLS004491910

MLS006011970

MolPort-001-002-058

MolPort-001-737-342

Mudrane

N1442

NC00542

NCGC00018117-01

NCGC00018117-02

NCGC00018117-03

NCGC00018117-04

NCGC00018117-05

NCGC00018117-06

NCGC00018117-07

NCGC00018117-08

NCGC00018117-09

NCGC00018117-10

NCGC00018117-11

NCGC00018117-12

NCGC00018117-13

NCGC00018117-14

NCGC00018117-15

NCGC00018117-16

NCGC00018117-17

NCGC00018117-18

NCGC00018117-19

NCGC00018117-20

NCGC00018117-23

NCGC00022112-03

NCGC00022112-04

NCGC00022112-05

NCGC00022112-07

NCGC00022112-08

NCGC00022112-09

NCGC00022112-10

NCGC00022112-11

NCGC00022112-12

NCGC00254040-01

NCGC00259924-01

NCI60_001736

NE11194

NINDS_000203

NSC 2066

NSC-2066

NSC-757346

NSC2066

NSC757346

Nuelin

Nuelin S.A

Nuelin SA

Opera_ID_76

Optiphyllin

Parkophyllin

PDSP1_001018

PDSP1_001234

PDSP2_001002

PDSP2_001218

Pharmakon1600-01500568

Physpa

Physpan

Prestwick0_000820

Prestwick0_000873

Prestwick1_000820

Prestwick1_000873

Prestwick2_000820

Prestwick2_000873

Prestwick3_000820

Prestwick3_000873

Pro-vent

Pseudotheophylline

PubChem9695

Pulmidur

Pulmo-Timelets

Purine-2,3H)-dione, 1,3-dimethyl-

Purine-2,6(1H,3H)-dione, 1,3-dimethyl-

Purine,6(1H,3H)-dione, 1,3-dimethyl-

Q-201819

Quadrinal

Quibron T

Quibron T-SR

Quibron T/SR

Quibron-T

Quibron-t (TN)

Quibron-T/SR

Respbid

Respicur

Respid

RP24142

SAM002554935

SBI-0050003.P004

SC-05534

SC-95891

SCHEMBL4915

SCHEMBL8312163

SDCCGMLS-0066620.P001

Slo-bid

Slo-phyllin

SMP1_000291

SMR000058537

SMR003435989

Solosin

Somophyllin CRT

Somophyllin T

Somophyllin-CRT

Somophyllin-DF

Somophyllin-t

SPBio_000823

SPBio_002640

SPBio_002866

Spectrum_001038

SPECTRUM1500568

Spectrum2_000842

Spectrum3_000672

Spectrum4_000353

Spectrum5_001232

Spophyllin retard

SR-01000075195

SR-01000075195-1

SR-01000075195-3

SR-01000075195-5

ST024762

STK397040

Sustaire

Synophylate

Synophylate-L.A. Cenules

T-Phyl

Talotren

Tefamin

Telb-DS

Telbans

Telbans Dry Syrup

Teocen 200

Teofilina

Teofilina [Polish]

Teofyllamin

Teolair

Teonova

Teosona

Tesona

Theacitin

Theal tabl.

Theal tablets

Theo 24

Theo-11

Theo-24

Theo-24 (TN)

Theo-DS

Theo-dur

Theo-Dur-Sprinkle

Theo-Nite

Theo-Organidin

Theobid

Theobid Duracap

THEOBID JR

Theobid Jr.

Theochron

Theocin

Theoclair-SR

Theoclear

Theoclear 80

Theoclear L.A.-130

Theoclear LA

Theoclear-200

Theoclear-80

Theoconfin Continuous

Theocontin

Theodel

Theodrip

Theodur

Theodur Dry Syrup

Theodur G (TN)

Theofol

Theograd

Theokin

Theolair

Theolair (TN)

Theolair-SR

Theolix

Theolixir

Theona P

Theonite

Theopek

Theophyl

Theophyl-225

Theophyl-SR

Theophyline

Theophyllin

Theophylline (1,3-dimethylxanthine)

Theophylline (anhydrous)

Theophylline (JP17)

Theophylline [USP]

Theophylline 1.0 mg/ml in Methanol

Theophylline aminoacetate

Theophylline anhydrous

Theophylline Anhydrous, USP

Theophylline Anhydrous,(S)

Theophylline melting point standard, Pharmaceutical Secondary Standard; Certified Reference Material

Theophylline melting point standard, United States Pharmacopeia (USP) Reference Standard

theophylline solu-tion

Theophylline solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material

Theophylline-SR

Theophylline, >=99.0% (HPLC)

Theophylline, 99+%, anhydrous

Theophylline, anhydrous

Theophylline, anhydrous, >=99%, powder

Theophylline, British Pharmacopoeia (BP) Reference Standard

Theophylline, certified reference material, United States Pharmacopeia (USP) Reference Standard

Theophylline, European Pharmacopoeia (EP) Reference Standard

Theophylline, Pharmaceutical Secondary Standard; Certified Reference Material

Theoplus

Theospan

Theostat

Theostat 80

Theotard

Theovent

Tox21_110827

Tox21_110827_1

Tox21_202375

Tox21_300028

Uni-Dur

Unicontin CR

Unifyl

UNII-0I55128JYK

Unilong

Uniphyl

Uniphyl (TN)

Uniphyllin

Uniphyllin continus

Uniphylline

UPCMLD-DP123

UPCMLD-DP123:001

WLN: T56 BM DN FNVNVJ F1 H1

X 115

Xanthine, 1,3-dimethyl-

Xanthine,3-dimethyl-

Xanthium

Xantivent

Z271004650

ZFXYFBGIUFBOJW-UHFFFAOYSA-N

ZINC18043251

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
Graham Dm	SOMOPHYLLIN-CRT	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	088383-001	Feb 27, 1985		DISCN	No	No
Graham Dm	SOMOPHYLLIN-CRT	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	088382-001	Feb 27, 1985		DISCN	No	No
Panray	THEOLIXIR	theophylline	ELIXIR;ORAL	084559-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Hospira Inc	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	019211-007	Dec 14, 1984		DISCN	Yes	No
Baxter Hlthcare	THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	018649-004	Jul 26, 1982		DISCN	No	No
Hospira Inc	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	019211-005	Dec 14, 1984		DISCN	No	No
Heritage Pharma	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	089807-001	Apr 30, 1990	AB	RX	No	Yes

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