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Details for New Drug Application (NDA): 021906

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NDA 021906 describes KALETRA, which is a drug marketed by Abbvie and is included in three NDAs. It is available from nine suppliers. There are twenty patents protecting this drug and two Paragraph IV challenges. Additional details are available on the KALETRA profile page.

The generic ingredient in KALETRA is lopinavir; ritonavir. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the lopinavir; ritonavir profile page.

Suppliers and Packaging for NDA: 021906

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lopinavir; ritonavir
TABLET;ORAL 021906 NDA AbbVie Inc. 0074-0522 0074-0522-60 60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60)
lopinavir; ritonavir
TABLET;ORAL 021906 NDA AbbVie Inc. 0074-6799 0074-6799-22 120 TABLET, FILM COATED in 1 BOTTLE (0074-6799-22)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;50MG
Approval Date:Oct 28, 2005TE:RLD:Yes
Patent:5,914,332*PEDPatent Expiration:Jun 13, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,037,157*PEDPatent Expiration:Dec 26, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,284,767*PEDPatent Expiration:Aug 15, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021906

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 20075,846,987*PED<disabled>
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 20055,674,882*PED<disabled>
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 20055,635,523*PED<disabled>
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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.