Carbidopa anhydrous
As of the edition of 20 October 2026, Carbidopa anhydrous is a small molecule: marketed, first approved in 1973 (ES); acts on DDC; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Sinemet
- First approved
- 1 November 1973 (ES)
- Approvals on record
- 32 in 6 regions
- Holder of the most recent approval
- Zambon; 12 holders in all
- Withdrawn from market
- 2 April 2019 (in some regions)
- Registered trials
- 122, 14 stopped early
- Disease areas
- Nervous system; Mental health; Eye; Heart and blood vessels; Inherited and neonatal; Chemically induced
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Amneal Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original drug.
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 Carbidopa anhydrous.
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 |
|---|---|---|
| DDC | Aromatic-L-amino-acid decarboxylase | P20711 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 5 | 3 | 0 |
| Phase 1 | 36 | 32 | 2 | 0 |
| Phase 2 | 40 | 29 | 2 | 8 |
| Phase 3 | 13 | 10 | 1 | 1 |
| Phase 4 | 24 | 13 | 4 | 5 |
| All trials | 122 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Orion Pharma | Applicant | 2003 to now |
| Novartis | Applicant and Lead sponsor of trials | 2004 to now |
| AbbVie | Applicant and Lead sponsor of trials | 2007 to now |
| Bausch Health | Acquired holder | 2011 to now |
| Tanabe Pharma | Later holder | 2026 to now |
| Zambon | Later holder | 2026 to now |
| Merck & Co. | Earlier holder |