FDA Orange Book · active-ingredient family
Theophylline
Theophylline is approved as 5 brand and 117 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER · NDA 019826
5
Brand (NDA)
117
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release, elixir, injectable, solution, solution, elixir, suspension, syrup, tablet, tablet, chewable, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINERRLD×6 | B BRAUN | NDA 019826 | — | Aug 14, 1992 | |
| THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×7 | HOSPIRA INC | NDA 019211 | — | Dec 14, 1984 | |
| THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER×3 | B BRAUN | NDA 019083 | — | Nov 07, 1984 | |
| THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER×3 | B BRAUN | NDA 019212 | — | Nov 07, 1984 | |
| THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER×7 | BAXTER HLTHCARE | NDA 018649 | — | Jul 26, 1982 |
Generic (ANDA) products (117)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| THEOPHYLLINE×2 | AJANTA PHARMA LTD | ANDA 218401 | — | Mar 26, 2025 | |
| THEOPHYLLINE×2 | STRIDES PHARMA | ANDA 215312 | AB | Sep 05, 2024 | |
| THEOPHYLLINE×2 | ZYDUS LIFESCIENCES | ANDA 218063 | AB | May 21, 2024 | |
| THEOPHYLLINE×2 | HARMAN FINOCHEM | ANDA 214806 | AB | Oct 24, 2023 | |
| THEOPHYLLINE×2 | ANNORA PHARMA | ANDA 217422 | AB | Sep 08, 2023 | |
| THEOPHYLLINE | RHODES PHARMS | ANDA 214113 | — | May 11, 2023 | |
| THEOPHYLLINE×2 | BIONPHARMA | ANDA 216300 | AB | Apr 26, 2023 | |
| THEOPHYLLINE×2 | AMNEAL | ANDA 216276 | AB | Mar 20, 2023 | |
| THEOPHYLLINE×2 | VELZEN PHARMA PVT | ANDA 214950 | AB | Jan 30, 2023 | |
| THEOPHYLLINE×2 | TEVA PHARMS INC | ANDA 216961 | AB | Oct 12, 2022 | |
| THEOPHYLLINE×2 | GLENMARK PHARMS LTD | ANDA 212184 | AB | Jun 03, 2021 | |
| THEOPHYLLINE | PHARM ASSOC | ANDA 206344 | — | Dec 16, 2016 | |
| THEOPHYLLINE | TRIS PHARMA INC | ANDA 091586 | AA | Jun 15, 2012 | |
| THEOPHYLLINE | CHARTWELL MOLECULAR | ANDA 091156 | AA | Apr 13, 2011 | |
| THEOPHYLLINE×2 | ALEMBIC | ANDA 090430 | AB | Oct 27, 2010 | |
| THEOPHYLLINE×2 | GLENMARK PHARMS LTD | ANDA 090355 | AB | Jul 13, 2010 | |
| THEOPHYLLINE×2 | MPP PHARMA | ANDA 040560 | AB | Apr 21, 2006 | |
| THEOPHYLLINE | ABLE | ANDA 040548 | — | Apr 30, 2004 | |
| THEOPHYLLINE | ABLE | ANDA 040546 | — | Apr 30, 2004 | |
| THEOPHYLLINE | ABLE | ANDA 040543 | — | Apr 27, 2004 | |
| THEOPHYLLINE | ABLE | ANDA 040539 | — | Apr 27, 2004 | |
| THEOPHYLLINE | INWOOD LABS | ANDA 040034 | — | Apr 28, 1995 | |
| THEOPHYLLINE | HOSPIRA | ANDA 089976 | — | Jan 04, 1995 | |
| THEOPHYLLINE | HOSPIRA | ANDA 089977 | — | Jan 04, 1995 | |
| THEOPHYLLINE | HOSPIRA | ANDA 089932 | — | Jan 04, 1995 | |
| UNI-DUR | SCHERING | ANDA 089822 | — | Jan 04, 1995 | |
| UNI-DUR | SCHERING | ANDA 089823 | — | Jan 04, 1995 | |
| THEOPHYLLINE×4 | INWOOD LABS | ANDA 040052 | — | Feb 14, 1994 | |
| THEOPHYLLINE | HERITAGE PHARMA AVET | ANDA 081236 | AB | Nov 09, 1992 | |
| THEOPHYLLINE | HERITAGE PHARMA AVET | ANDA 089807 | — | Apr 30, 1990 | |
| THEOPHYLLINE | HERITAGE PHARMA AVET | ANDA 089808 | — | Apr 30, 1990 | |
| THEOPHYLLINE | HERITAGE PHARMA AVET | ANDA 089763 | AB | Apr 30, 1990 | |
| SLO-BID | SANOFI AVENTIS US | ANDA 089539 | — | May 10, 1989 | |
| SLO-BID | SANOFI AVENTIS US | ANDA 089540 | — | May 10, 1989 | |
| THEOPHYLLINE | SUN PHARMA CANADA | ANDA 089626 | — | Oct 28, 1988 | |
| THEOPHYLLINE | ALPHARMA US PHARMS | ANDA 089223 | — | May 27, 1988 | |
| THEOLAIR-SR | 3M | ANDA 088369 | — | Jul 16, 1987 | |
| THEOLAIR-SR | 3M | ANDA 086363 | — | Jul 16, 1987 | |
| THEOLAIR-SR | 3M | ANDA 088364 | — | Jul 16, 1987 | |
| THEOLAIR-SR | 3M | ANDA 089132 | — | Jul 16, 1987 | |
| AEROLATE | FLEMING PHARMS | ANDA 089141 | — | Dec 03, 1986 | |
| AEROLATE III×3 | FLEMING PHARMS | ANDA 085075 | — | Nov 24, 1986 | |
| THEOPHYLLINE×3 | SCHERER RP | ANDA 084731 | — | Nov 07, 1986 | |
| THEO-DUR | SCHERING | ANDA 089131 | — | Jun 25, 1986 | |
| THEOPHYLLINE-SR | SCHERER RP | ANDA 088255 | — | Jun 12, 1986 | |
| ACCURBRON | SANOFI AVENTIS US | ANDA 088746 | — | Nov 22, 1985 | |
| THEOPHYL | ORTHO MCNEIL PHARM | ANDA 086506 | — | Sep 12, 1985 | |
| THEO-DUR | SCHERING | ANDA 088022 | — | Sep 10, 1985 | |
| THEO-DUR | SCHERING | ANDA 088015 | — | Sep 10, 1985 | |
| THEO-DUR | SCHERING | ANDA 088016 | — | Sep 10, 1985 | |
| THEO-DUR | SCHERING | ANDA 087995 | — | Sep 10, 1985 | |
| QUIBRON-T | MONARCH PHARMS | ANDA 088656 | — | Aug 22, 1985 | |
| DURAPHYL | FOREST LABS | ANDA 088503 | — | Apr 03, 1985 | |
| DURAPHYL | FOREST LABS | ANDA 088504 | — | Apr 03, 1985 | |
| DURAPHYL | FOREST LABS | ANDA 088505 | — | Apr 03, 1985 | |
| THEOBID | WHITBY | ANDA 085983 | — | Mar 20, 1985 | |
| THEOBID JR. | WHITBY | ANDA 087854 | — | Mar 20, 1985 | |
| SOMOPHYLLIN-CRT | GRAHAM DM | ANDA 087763 | — | Feb 27, 1985 | |
| SOMOPHYLLIN-CRT | GRAHAM DM | ANDA 088382 | — | Feb 27, 1985 | |
| SOMOPHYLLIN-CRT | GRAHAM DM | ANDA 088383 | — | Feb 27, 1985 | |
| SOMOPHYLLIN-T×3 | FISONS | ANDA 087155 | — | Feb 25, 1985 | |
| THEOPHYLLINE×4 | NOSTRUM PHARMS LLC | ANDA 087400 | — | Feb 21, 1985 | |
| THEOPHYLLINE | CENT PHARMS | ANDA 088654 | — | Feb 12, 1985 | |
| THEOPHYLLINE | CENT PHARMS | ANDA 088689 | — | Feb 12, 1985 | |
| THEOPHYL-SR | ORTHO MCNEIL PHARM | ANDA 086480 | — | Feb 08, 1985 | |
| THEOPHYL-SR | ORTHO MCNEIL PHARM | ANDA 086471 | — | Feb 08, 1985 | |
| SLO-BID | SANOFI AVENTIS US | ANDA 088269 | — | Jan 31, 1985 | |
| SLO-BID | SANOFI AVENTIS US | ANDA 087892 | — | Jan 31, 1985 | |
| SLO-BID | SANOFI AVENTIS US | ANDA 087893 | — | Jan 31, 1985 | |
| SLO-BID | SANOFI AVENTIS US | ANDA 087894 | — | Jan 31, 1985 | |
| THEOVENT | SCHERING | ANDA 087010 | — | Jan 31, 1985 | |
| THEOVENT | SCHERING | ANDA 087910 | — | Jan 31, 1985 | |
| ELIXOPHYLLIN SR×2 | FOREST LABS | ANDA 086826 | — | Jan 29, 1985 | |
| ELIXOPHYLLIN | FOREST LABS | ANDA 085545 | — | Jul 31, 1984 | |
| ELIXOPHYLLIN | FOREST LABS | ANDA 083921 | — | Jul 31, 1984 | |
| ELIXOMIN | CENCI | ANDA 088303 | — | Jan 25, 1984 | |
| THEOPHYLLINERLD | ROXANE | ANDA 087449 | — | Sep 15, 1983 | |
| THEO-24RLD×4 | ENDO OPERATIONS | ANDA 087943 | — | Aug 22, 1983 | |
| T-PHYL | PHARM RES ASSOC | ANDA 088253 | — | Aug 17, 1983 | |
| QUIBRON-T/SR | MONARCH PHARMS | ANDA 087563 | — | Jun 21, 1983 | |
| AQUAPHYLLIN | FERNDALE LABS | ANDA 087917 | — | Jan 18, 1983 | |
| THEOPHYLLINERLD×2 | RHODES PHARMS | ANDA 040086 | AB | Sep 01, 1982 | |
| THEOCLEAR L.A.-130×2 | SCHWARZ PHARMA | ANDA 086569 | — | May 27, 1982 | |
| SLO-PHYLLIN | SANOFI AVENTIS US | ANDA 085206 | — | May 24, 1982 | |
| SLO-PHYLLINRLD | SANOFI AVENTIS US | ANDA 085203 | — | May 24, 1982 | |
| SLO-PHYLLIN | SANOFI AVENTIS US | ANDA 085205 | — | May 24, 1982 | |
| THEOPHYLLINE | SANDOZ | ANDA 087462 | — | May 11, 1982 | |
| THEOPHYLLINE | CENCI | ANDA 087679 | — | Apr 15, 1982 | |
| THEOCLEAR-80 | CENT PHARMS | ANDA 087095 | — | Mar 01, 1982 | |
| SOMOPHYLLIN-CRT | GRAHAM DM | ANDA 087194 | — | Approved Prior to Jan 1, 1982 | |
| SOMOPHYLLIN-CRTRLD | GRAHAM DM | ANDA 087193 | — | Approved Prior to Jan 1, 1982 | |
| BRONKODYL×2 | SANOFI AVENTIS US | ANDA 085264 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYLLINE×2 | KV PHARM | ANDA 085263 | — | Approved Prior to Jan 1, 1982 | |
| LANOPHYLLIN | LANNETT | ANDA 084578 | — | Approved Prior to Jan 1, 1982 | |
| THEOLIXIR | PANRAY | ANDA 084559 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYL-225 | ORTHO MCNEIL PHARM | ANDA 086485 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYLLINE | CHARTWELL RX | ANDA 085952 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYLLINE | HALSEY | ANDA 085169 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYLLINE | PHARM ASSOC | ANDA 086720 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYLLINERLD | PRECISION DOSE | ANDA 085863 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYLLINE | ROXANE | ANDA 084739 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYLLINE | WOCKHARDT | ANDA 086748 | — | Approved Prior to Jan 1, 1982 | |
| ELIXOPHYLLINRLD | SOLIS PHARMS | ANDA 085186 | — | Approved Prior to Jan 1, 1982 | |
| THEOLAIR | 3M | ANDA 086107 | — | Approved Prior to Jan 1, 1982 | |
| ELIXICON | FOREST LABS | ANDA 085502 | — | Approved Prior to Jan 1, 1982 | |
| SLO-PHYLLIN | SANOFI AVENTIS US | ANDA 085187 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYLLINE | ALPHARMA US PHARMS | ANDA 086001 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYLLINERLD | ALPHARMA US PHARMS | ANDA 086545 | — | Approved Prior to Jan 1, 1982 | |
| LABID | WARNER CHILCOTT | ANDA 087225 | — | Approved Prior to Jan 1, 1982 | |
| SUSTAIRE×2 | ROERIG | ANDA 085665 | — | Approved Prior to Jan 1, 1982 | |
| THEO-DURRLD×2 | SCHERING | ANDA 085328 | — | Approved Prior to Jan 1, 1982 | |
| THEO-DURRLD | SCHERING | ANDA 086998 | — | Approved Prior to Jan 1, 1982 | |
| SLO-PHYLLIN | SANOFI AVENTIS US | ANDA 085202 | — | Approved Prior to Jan 1, 1982 | |
| SLO-PHYLLIN | SANOFI AVENTIS US | ANDA 085204 | — | Approved Prior to Jan 1, 1982 | |
| THEOCLEAR-100×2 | CENT PHARMS | ANDA 085353 | — | Approved Prior to Jan 1, 1982 | |
| THEOLAIR×2 | MEDICIS | ANDA 086399 | — | Approved Prior to Jan 1, 1982 | |
| THEOPHYL-225 | ORTHO MCNEIL PHARM | ANDA 084726 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Theophylline — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
