Drug facts
MoleculeCarbidopa and Levodopa (Rytary)
Generics already compete: 13 makers on the market. 40 A-rated products from 13 makers substitute at the counter.
Sinemet was first approved by the FDA before 1982 under NDA 017555; the application holder is Organon LLC A Sub of Organon and Co.
The latest NADAC for CARBIDOPA-LEVO ER 25-100 TAB is $0.11 per unit (as of 10/28/2026).
Holder Organon LLC A Sub of Organon and CoApplication NDA 017555Approved before 1982
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
- Latest patent
- No Sinemet patent listed in the Orange Book Orange Book
- Later patents, other products
- Crexont 12/21/2041; Dhivy 03/28/2039; Rytary 12/26/2028 Orange Book
02Competition
- Generics
- 13 generic makers Orange Book
- First generic approved
- 08/28/1992 Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Carbidopa and Levodopa profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.11 per unitCARBIDOPA-LEVO ER 25-100 TAB, mid-priced of 5 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 10/07/2025Class II, Carbidopa, Levodopa and Entacapone, Rising Pharma Holding, Inc. FDA enforcement
04Product
- Application holder
- Organon LLC A Sub of Organon and Co Orange Book
- Application
- NDA 017555 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- capsule, extended release; suspension; tablet; tablet, extended release; tablet, orally disintegrating
- Routes
- enteral, oral
- Other brand names
- CrexontDhivyDuopaSinemet
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.