Drug facts
MoleculeLevothyroxine (Synthroid)
Generics already compete: 11 makers on the market. 94 A-rated products from 11 makers substitute at the counter.
Unithroid was first approved by the FDA on 08/21/2000 under NDA 021210; the application holder is Jerome Stevens Pharmaceuticals Inc.
The latest NADAC for LEVOTHYROXINE 112 MCG TABLET is $0.06 per unit (as of 10/28/2026).
Holder Jerome Stevens Pharmaceuticals IncApplication NDA 021210Approved 08/21/2000
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 Unithroid patent listed in the Orange Book Orange Book
- Later patents, other products
- Tirosint 09/26/2044; Tirosint-Sol 09/26/2044; Levolet 03/23/2038; Levothyroxine Sodium (NDA 210632) 12/01/2036; Levothyroxine Sodium (NDA 214253) 07/20/2036 Orange Book
02Competition
- Generics
- 11 generic makers Orange Book
- First generic approved
- 06/05/2002 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 Levothyroxine profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.06 per unitLEVOTHYROXINE 112 MCG TABLET, mid-priced of 12 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 08/06/2026Class II, Levothyroxine Sodium, Accord Healthcare, Inc. FDA enforcement
04Product
- Application holder
- Jerome Stevens Pharmaceuticals Inc Orange Book
- Application
- NDA 021210 Orange Book
- First approved
- 08/21/2000 Orange Book
- Dosage forms
- capsule; powder; solution; tablet
- Routes
- intravenous, oral
- Other brand names
- Levo-TLevoletLevoxylThyquidityThyro-TabsTirosint
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.