Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020375

« Back to Dashboard
NDA 020375 describes CLIMARA, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the CLIMARA profile page.

The generic ingredient in CLIMARA is estradiol; levonorgestrel. There are seventy-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the estradiol; levonorgestrel profile page.

Summary for NDA: 020375

Bayer Hlthcare
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020375

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 020375

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FILM, EXTENDED RELEASE;TRANSDERMAL 020375 NDA Alvogen, Inc. 47781-204 47781-204-04 4 PATCH in 1 CARTON (47781-204-04) > 7 d in 1 PATCH
FILM, EXTENDED RELEASE;TRANSDERMAL 020375 NDA Alvogen, Inc. 47781-205 47781-205-04 4 PATCH in 1 CARTON (47781-205-04) > 7 d in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Dec 22, 1994TE:AB2RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/24HR
Approval Date:Dec 22, 1994TE:AB2RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.075MG/24HR
Approval Date:Mar 23, 1998TE:AB2RLD:No

Expired Orange Book Patents for NDA: 020375

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
FILM, EXTENDED RELEASE;TRANSDERMAL020375-004Mar 5, 19995,223,261► subscribe
Bayer Hlthcare
FILM, EXTENDED RELEASE;TRANSDERMAL020375-003Mar 23, 19985,223,261► subscribe
Bayer Hlthcare
FILM, EXTENDED RELEASE;TRANSDERMAL020375-002Dec 22, 19945,223,261► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.