.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate 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): 021073

« Back to Dashboard
NDA 021073 describes ACTOS, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from twelve suppliers. There are ten patents protecting this drug. Additional details are available on the ACTOS profile page.

The generic ingredient in ACTOS is pioglitazone hydrochloride. There are twenty-seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the pioglitazone hydrochloride profile page.

Summary for NDA: 021073

Tradename:
ACTOS
Applicant:
Takeda Pharms Usa
Ingredient:
pioglitazone hydrochloride
Patents:10
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 021073

Suppliers and Packaging for NDA: 021073

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTOS
pioglitazone hydrochloride
TABLET;ORAL 021073 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-2046 0093-2046-05 500 TABLET in 1 BOTTLE (0093-2046-05)
ACTOS
pioglitazone hydrochloride
TABLET;ORAL 021073 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-2046 0093-2046-56 30 TABLET in 1 BOTTLE (0093-2046-56)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Jul 15, 1999TE:ABRLD:No
Patent:6,172,090Patent Expiration:Jun 19, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
Patent:6,166,043Patent Expiration:Jun 19, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
Patent:6,166,042Patent Expiration:Jun 19, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING GLYCOMETABOLISM DISORDERS BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE

Expired Orange Book Patents for NDA: 021073

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 19996,271,243► subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 19996,166,042► subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 19996,150,384► 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.

`abc