Loratadine
As of the edition of 20 October 2026, Loratadine is a small molecule: marketed, first approved in 1988 (CA); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Claritin
- First approved
- 18 December 1988 (CA)
- Approvals on record
- 28 in 5 regions
- Holder of the most recent approval
- Bayer; 6 holders in all
- Registered trials
- 58, 5 stopped early
- Disease areas
- Immune system; Lungs and airways; Ear, nose and throat; Infections; Blood and lymph; Cancer
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 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Loratadine.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 5 | 2 | 0 |
| Phase 1 | 12 | 8 | 1 | 2 |
| Phase 2 | 10 | 5 | 2 | 2 |
| Phase 3 | 15 | 12 | 0 | 1 |
| Phase 4 | 13 | 9 | 1 | 0 |
| All trials | 58 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant, Acquired holder and Lead sponsor of trials | 1988 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2002 to now |
| Pfizer | Later holder | 2002 to now |
| Perrigo | Later holder | 2004 to now |
| Taro Pharmaceuticals | Later holder | 2005 to now |
| Schering Plough Healthcare | Later holder | 2006 to now |
| Foundation Consumer Brands | Acquired holder | 2020 to now |
| Sun Pharma | Acquired holder | 2025 to now |