Drug
Who makes estradiol?
43 companies list estradiol as a human prescription drug, including under the names Climara, DIVIGEL, ELESTRIN, Estring, EstroGel, Evamist, Menostar, Minivelle. Forms: cream; film, extended release; gel; gel, metered; insert; patch; patch, extended release; spray; system; tablet; tablet, film coated. Routes: oral, topical, transdermal, vaginal.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing estradiol
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | cream; gel; insert; patch, extended release | ANDAANDA040197, ANDA040275, ANDA206388 | 25 | 1 |
| International Medication Systems, Ltd.United States | cream; film, extended release; patch; tablet | ANDA, NDA AUTHORIZED GENERICANDA040197, ANDA040275, ANDA075182 | 21 | 3 |
| Mylan Pharmaceuticals, Inc. | cream; patch | ANDAANDA075182, ANDA201675, ANDA206685 | 17 | 0 |
| Sandoz Industrial Products S.AAustria | patch; patch, extended release | NDA, NDA AUTHORIZED GENERICNDA020375, NDA020538 | 16 | 5 |
| Zydus Lifesciences LimitedIndia | patch; patch, extended release | ANDAANDA202985, ANDA204379, ANDA206241 | 12 | 12 |
| Zydus Pharmaceuticals USA Inc.India | patch; patch, extended release | ANDAANDA202985, ANDA204379, ANDA206241 | 12 | 1 |
| Amneal Ireland LimitedIreland | patch, extended release; tablet | ANDAANDA205256, ANDA211293, ANDA211396 | 11 | 1 |
| Noven Pharmaceuticals, Inc.United States | film, extended release | NDA, NDA AUTHORIZED GENERICNDA203752 | 10 | 1 |
| Amneal Pharmaceuticals NY LLC | patch, extended release | ANDAANDA211293, ANDA211396 | 10 | 0 |
| ANI Pharmaceuticals, Inc.United States | gel; gel, metered; tablet | ANDAANDA217334, ANDA217610, ANDA217882 | 9 | 1 |
| Northstar Rx, LLC, | gel; tablet; tablet, film coated | ANDAANDA216550, ANDA217334, ANDA217610 | 9 | 0 |
| Bayer Healthcare Manufacturing SrlGermany | patch | NDANDA020375 | 7 | 13 |
| Encube Ethicals LimitedIndia | cream; gel | ANDAANDA209767, ANDA218214, ANDA218507 | 7 | 5 |
| Padagis Israel Pharmaceuticals LtdUnited States | cream; gel; spray | ANDA, NDAANDA210194, ANDA216524, NDA022014 | 7 | 2 |
| NuCare Pharmaceuticals,Inc.United States | cream; tablet | ANDAANDA040197, ANDA040275, ANDA210194 | 7 | 1 |
| Teva Pharmaceutical Industries Ltd.Canada | cream; insert; tablet | ANDAANDA040197, ANDA086069, ANDA206388 | 5 | 6 |
| Northwind Health Company, LLCUnited States | tablet | ANDAANDA040197, ANDA040275, ANDA217334 | 5 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA040197, ANDA040275, ANDA217334 | 5 | 1 |
| Trigen Laboratories, LLC | gel | NDANDA022038 | 5 | 0 |
| Vertical Pharmaceuticals, LLC | gel | NDANDA022038 | 5 | 0 |
| Epic Laboratories, LLCUnited States | tablet | ANDAANDA040275 | 3 | 3 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDAANDA040275 | 3 | 1 |
| Direct RxUnited States | tablet | ANDAANDA040275, ANDA217334 | 3 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA040197, ANDA217334 | 3 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA040275, ANDA217334 | 3 | 1 |
| RedPharm DrugUnited States | cream; tablet | ANDAANDA209767, ANDA210194, ANDA217334 | 3 | 1 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals | tablet | ANDAANDA040275 | 3 | 0 |
| PharmPak, Inc.United States | tablet | ANDAANDA040197 | 2 | 1 |
| AvKARE | cream; tablet | ANDAANDA205256, ANDA210194 | 2 | 0 |
| Viatris Inc.India | gel, metered | NDANDA021813 | 1 | 18 |
| Amneal Pharmaceuticals of New York, LLCIndia | insert | ANDAANDA205256 | 1 | 14 |
| Novo Nordisk Inc.Denmark | insert | NDANDA020908 | 1 | 11 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet, film coated | ANDAANDA210264 | 1 | 9 |
| Allergan, Inc.United States | cream | ANDAANDA086069 | 1 | 7 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA216550 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA040197 | 1 | 5 |
| Coupler LLCUnited States | tablet | ANDAANDA217334 | 1 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA040197 | 1 | 1 |
| Solaris Pharma CorporationUnited States | gel | ANDAANDA216160 | 1 | 1 |
| ASCEND Therapeutics US, LLC | gel, metered | NDANDA021166 | 1 | 0 |
| Alvogen, Inc. | cream | ANDAANDA209767 | 1 | 0 |
| Pfizer Laboratories Div Pfizer Inc | system | NDANDA020472 | 1 | 0 |
| Prasco Laboratories | cream | ANDAANDA212313 | 1 | 0 |
Bulk ingredient listings
- Qinhuangdao Zizhu Pharmaceutical Co LtdChina · 2 NDC
- XENEX LABORATORIES INCCanada · 2 NDC
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 1 NDC
- Aspen Oss B.V.Netherlands · 1 NDC
- Cutyx Research LLPIndia · 1 NDC
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 1 NDC
- Gedeon Richter Plc.Hungary · 1 NDC
- Hubei Gedian Humanwell Pharmaceutical Co., LtdChina · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
24 unexpired patents list estradiol as the active ingredient, expiring between Jul 2028 and Feb 2034. Application holders: MAYNE PHARMA LLC, NOVEN PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes estradiol?
- 43 companies list estradiol as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, International Medication Systems, Ltd., Mylan Pharmaceuticals, Inc., Sandoz Industrial Products S.A, Zydus Lifesciences Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Climara?
- 34 companies list estradiol under an abbreviated new drug application (ANDA), the application type used for generics, and 10 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies estradiol active ingredient?
- 10 companies list estradiol as a bulk ingredient, including Qinhuangdao Zizhu Pharmaceutical Co Ltd, XENEX LABORATORIES INC, ASCLEMED USA INC. DBA ENOVACHEM, Aspen Oss B.V..