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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, 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 |
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 |
Pharmacology for theophylline
Drug Class | Methylxanthine |
Medical Subject Heading (MeSH) Categories for theophylline
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 | Start Trial | Start Trial | Start Trial | ||||
Graham Dm | SOMOPHYLLIN-CRT | theophylline | CAPSULE, EXTENDED RELEASE;ORAL | 088382-001 | Feb 27, 1985 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Panray | THEOLIXIR | theophylline | ELIXIR;ORAL | 084559-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Hospira Inc | THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | theophylline | INJECTABLE;INJECTION | 019211-007 | Dec 14, 1984 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Baxter Hlthcare | THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER | theophylline | INJECTABLE;INJECTION | 018649-004 | Jul 26, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Hospira Inc | THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | theophylline | INJECTABLE;INJECTION | 019211-005 | Dec 14, 1984 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Heritage Pharma | THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 089807-001 | Apr 30, 1990 | AB | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
>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
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 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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