KALETRA Drug Patent Profile
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Which patents cover Kaletra, and what generic alternatives are available?
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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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 |
|---|---|
| OHSU Knight Cancer Institute | Phase 2 |
| Oregon Health and Science University | Phase 2 |
| Beni-Suef 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 | 021906-002 | Nov 9, 2007 | ⤷ 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 |
| >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 |
|---|---|---|---|
| Mexico | 2007010275 | FORMULACION DE DOSIFICACION FARMACEUTICA SOLIDA. (A SOLID PHARMACEUTICAL DOSAGE FORMULATION.) | ⤷ Sign Up |
| Japan | 5087409 | ⤷ Sign Up | |
| Germany | 50111376 | ⤷ Sign Up | |
| European Patent Office | 0876353 | ⤷ 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 | 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 |
| 0674513 | C00674513 | Switzerland | ⤷ Sign Up | PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & 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 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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