Theophylline anhydrous
As of the edition of 20 October 2026, Theophylline anhydrous is a protein: marketed, first approved in 1979 (CA); acts on ADORA1, ADORA2A and ADORA2B and 7 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1985
- Kind
- Protein
- Brand name
- Choledyl
- First approved
- 31 December 1979 (CA)
- Approvals on record
- 43 in 3 regions
- Holder of the most recent approval
- Bausch Health; 12 holders in all
- Registered trials
- 74, 8 stopped early
- Disease areas
- Lungs and airways; Nervous system; Immune system; Urinary and reproductive; Nutrition and metabolism; Pregnancy and women's health
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Theophylline anhydrous.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| ADORA3 | Adenosine receptor A3 | P0DMS8 |
| PDE4A | 3',5'-cyclic-AMP phosphodiesterase 4A | P27815 |
| ADORA2A | Adenosine receptor A2a | P29274 |
| ADORA2B | Adenosine receptor A2b | P29275 |
| ADORA1 | Adenosine receptor A1 | P30542 |
| PDE4B | 3',5'-cyclic-AMP phosphodiesterase 4B | Q07343 |
| PDE4C | 3',5'-cyclic-AMP phosphodiesterase 4C | Q08493 |
| PDE4D | 3',5'-cyclic-AMP phosphodiesterase 4D | Q08499 |
| PDE3B | cGMP-inhibited 3',5'-cyclic phosphodiesterase 3B | Q13370 |
| PDE3A | cGMP-inhibited 3',5'-cyclic phosphodiesterase 3A | Q14432 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 17 | 11 | 1 | 1 |
| Phase 1 | 14 | 10 | 0 | 3 |
| Phase 2 | 17 | 11 | 6 | 0 |
| Phase 3 | 11 | 10 | 1 | 0 |
| Phase 4 | 15 | 10 | 1 | 4 |
| All trials | 74 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant, Acquired holder and Later holder | 1981 to now |
| Fisons | Later holder | 1982 to now |
| Baxter Healthcare | Later holder | 1982 to now |
| B. Braun Medical | Later holder | 1984 to now |
| Abbott | Later holder | 1984 to now |
| Bausch Health | Acquired holder | 1992 to now |