Drug facts
MoleculeEstradiol (Estring)
Generics already compete: 19 makers on the market. 90 A-rated products from 19 makers substitute at the counter.
Estraderm was first approved by the FDA on 09/10/1986 under NDA 019081; the application holder is Novartis Pharmaceuticals Corp. The Orange Book lists NDA 019081 as discontinued.
The latest NADAC for ESTRADIOL 1 MG TABLET is $0.06 per unit (as of 10/28/2026).
Holder Novartis Pharmaceuticals CorpApplication NDA 019081Approved 09/10/1986
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 Estraderm patent listed in the Orange Book Orange Book
- Later patents, other products
- Imvexxy 02/02/2034; Minivelle 07/04/2030 Orange Book
02Competition
- Generics
- 19 generic makers Orange Book
- First generic approved
- before 1982 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 Estradiol profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.06 per unitESTRADIOL 1 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 09/08/2026Class II, Estradiol Transdermal, Amneal Pharmaceuticals, LLC FDA enforcement
04Product
- Application holder
- Novartis Pharmaceuticals Corp Orange Book
- Application
- NDA 019081 Orange Book
- First approved
- 09/10/1986 Orange Book
- Dosage forms
- cream; film, extended release; gel; gel, metered; insert; insert, extended release
- Routes
- oral, transdermal, vaginal
- Other brand names
- ClimaraDivigelElestrinEstraceEstrogelEvamist
- Status
- NDA 019081 discontinued Orange Book
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.