kaletra Drug Patent Profile
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Which patents cover Kaletra, 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. Six 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 LANNETT CO INC on December 27th, 2016.
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Questions you can ask:
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Summary for kaletra
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 152 |
Drug Prices: | Drug price information for kaletra |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for kaletra |
What excipients (inactive ingredients) are in kaletra? | kaletra excipients list |
DailyMed Link: | kaletra at DailyMed |
Recent Clinical Trials for kaletra
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Oregon Health and Science University | Phase 2 |
OHSU Knight Cancer Institute | Phase 2 |
October 6 University | Phase 4 |
Pharmacology 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Abbvie | KALETRA | lopinavir; ritonavir | SOLUTION;ORAL | 021251-001 | Sep 15, 2000 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-002 | Nov 9, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for kaletra
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | KALETRA | lopinavir; ritonavir | CAPSULE;ORAL | 021226-001 | Sep 15, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | KALETRA | lopinavir; ritonavir | SOLUTION;ORAL | 021251-001 | Sep 15, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | KALETRA | lopinavir; ritonavir | SOLUTION;ORAL | 021251-001 | Sep 15, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for kaletra
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Mylan Pharmaceuticals Limited | Lopinavir/Ritonavir Mylan | lopinavir, ritonavir | EMEA/H/C/004025 Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.The choice of lopinavir/ritonavir to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients. |
Authorised | yes | no | no | 2016-01-14 | |
AbbVie Deutschland GmbH Co. KG | Kaletra | lopinavir, ritonavir | EMEA/H/C/000368 Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older.The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients. |
Authorised | no | no | no | 2001-03-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for kaletra
See the table below for patents covering kaletra around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2285119 | COMPOSES INHIBITEURS DE PROTESE RETROVIRALE (RETROVIRAL PROTEASE INHIBITING COMPOUNDS) | ⤷ Sign Up |
Israel | 94444 | Retroviral protease inhibiting compounds pharmaceutical compositions containing them and process for their preparation | ⤷ Sign Up |
European Patent Office | 0402646 | Composés inhibiteurs de la protease retrovirale (Retroviral protease inhibiting compounds) | ⤷ Sign Up |
Serbia | 57378 | FORMULACIJA ČVRSTOG OBLIKA DOZIRANJA KOJA SADRŽI LOPINAVIR (A SOLID PHARMACEUTICAL DOSAGE FORMULATION COMPRISING LOPINAVIR) | ⤷ Sign Up |
Georgia, Republic of | P20105083 | A SOLID PHARMACEUTICAL DOSAGE FORMULATION | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for kaletra
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0674513 | C00674513 | Switzerland | ⤷ Sign Up | PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213 |
0674513 | C300060 | Netherlands | ⤷ Sign Up | 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 | SPC/GB01/044 | United Kingdom | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |