LOPINAVIR AND RITONAVIR Drug Patent Profile
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Which patents cover Lopinavir And Ritonavir, and when can generic versions of Lopinavir And Ritonavir launch?
Lopinavir And Ritonavir is a drug marketed by Lannett Co Inc, Hetero Labs Ltd Iii, Laurus, Macleods Pharms Ltd, and Mylan Labs Ltd. and is included in five NDAs.
The generic ingredient in LOPINAVIR AND RITONAVIR 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 Lopinavir And Ritonavir
A generic version of LOPINAVIR AND RITONAVIR was approved as lopinavir; ritonavir by LANNETT CO INC on December 27th, 2016.
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Summary for LOPINAVIR AND RITONAVIR
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 340 |
| Patent Applications: | 139 |
| DailyMed Link: | LOPINAVIR AND RITONAVIR at DailyMed |
Recent Clinical Trials for LOPINAVIR AND RITONAVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Washington | Phase 1 |
| University of Wisconsin, Madison | Phase 1 |
| Wisconsin Partnership Program | Phase 1 |
Pharmacology for LOPINAVIR AND RITONAVIR
US Patents and Regulatory Information for LOPINAVIR AND RITONAVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lannett Co Inc | LOPINAVIR AND RITONAVIR | lopinavir; ritonavir | SOLUTION;ORAL | 207407-001 | Dec 27, 2016 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | LOPINAVIR AND RITONAVIR | lopinavir; ritonavir | TABLET;ORAL | 204739-002 | Jul 25, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Laurus | LOPINAVIR AND RITONAVIR | lopinavir; ritonavir | TABLET;ORAL | 213857-001 | Mar 21, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Labs Ltd | LOPINAVIR AND RITONAVIR | lopinavir; ritonavir | TABLET;ORAL | 079074-001 | Feb 7, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd Iii | LOPINAVIR AND RITONAVIR | lopinavir; ritonavir | TABLET;ORAL | 091677-001 | Jun 4, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd Iii | LOPINAVIR AND RITONAVIR | lopinavir; ritonavir | TABLET;ORAL | 091677-002 | Jun 4, 2021 | AB | RX | No | 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 |
EU/EMA Drug Approvals for LOPINAVIR AND RITONAVIR
| 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 |
