KALETRA Drug Patent Profile
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When do Kaletra patents expire, and when can generic versions of Kaletra launch?
Kaletra is a drug marketed by Abbvie and is included in three NDAs.
The generic ingredient in KALETRA is lopinavir; ritonavir. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Kaletra
A generic version of KALETRA was approved as lopinavir; ritonavir by HETERO LABS LTD III on June 4th, 2021.
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Questions you can ask:
- What is the 5 year forecast for KALETRA?
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Summary for KALETRA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KALETRA |
Paragraph IV (Patent) Challenges for KALETRA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KALETRA | Oral Solution | lopinavir; ritonavir | 80 mg/20 mg per mL | 021251 | 1 | 2014-06-19 |
| KALETRA | Tablets | lopinavir; ritonavir | 100 mg/25 mg and 200 mg/50 mg | 021906 | 1 | 2008-12-23 |
US Patents and Regulatory Information for KALETRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | KALETRA | lopinavir; ritonavir | CAPSULE;ORAL | 021226-001 | Sep 15, 2000 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Abbvie | KALETRA | lopinavir; ritonavir | SOLUTION;ORAL | 021251-001 | Sep 15, 2000 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-002 | Nov 9, 2007 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for KALETRA
See the table below for patents covering KALETRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 143262 | ⤷ Start Trial | |
| Austria | 168677 | ⤷ Start Trial | |
| Austria | 196761 | ⤷ Start Trial | |
| Austria | 213733 | ⤷ Start Trial | |
| Austria | 230402 | ⤷ Start Trial | |
| Austria | 302180 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KALETRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0674513 | SPC/GB01/044 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: THE COMBINATION OF THE ACTIVE INGREDIENTS RITONAVIR AND LOPINAVIR; REGISTERED: CH 55649 20001213; UK EU/1/01/172/001 20010320; UK EU/1/01/172/002 20010320; UK EU/1/01/172/003 20010320 |
| 0674513 | C300060 | Netherlands | ⤷ Start Trial | PRODUCT NAME: RITONAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN FARMACEUTISCH AANVAARDBARE ESTER, EN LOPINAVIR; REGISTRATION NO/DATE: EU/1/01/172/001 - EU/1/01/172/003 20010320 |
| 0674513 | C00674513 | Switzerland | ⤷ Start Trial | PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.
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