NORVIR Drug Patent Profile
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Which patents cover Norvir, and what generic alternatives are available?
Norvir is a drug marketed by Abbott and Abbvie and is included in five NDAs.
The generic ingredient in NORVIR is ritonavir. There are twenty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ritonavir profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Norvir
A generic version of NORVIR was approved as ritonavir by CIPLA on January 15th, 2015.
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Summary for NORVIR
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 95 |
| Patent Applications: | 4,162 |
| Drug Prices: | Drug price information for NORVIR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NORVIR |
| What excipients (inactive ingredients) are in NORVIR? | NORVIR excipients list |
| DailyMed Link: | NORVIR at DailyMed |
Recent Clinical Trials for NORVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pyramid Biosciences | Phase 1 |
| Pardes Biosciences, Inc. | Phase 1 |
| Soroka University Medical Center | Phase 3 |
Pharmacology for NORVIR
US Patents and Regulatory Information for NORVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott | NORVIR | ritonavir | CAPSULE;ORAL | 020680-001 | Mar 1, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | NORVIR | ritonavir | SOLUTION;ORAL | 020659-001 | Mar 1, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | NORVIR | ritonavir | CAPSULE;ORAL | 020945-001 | Jun 29, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | NORVIR | ritonavir | POWDER;ORAL | 209512-001 | Jun 7, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | NORVIR | ritonavir | TABLET;ORAL | 022417-001 | Feb 10, 2010 | AB | RX | Yes | Yes | ⤷ 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 NORVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | NORVIR | ritonavir | CAPSULE;ORAL | 020945-001 | Jun 29, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | NORVIR | ritonavir | CAPSULE;ORAL | 020945-001 | Jun 29, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | NORVIR | ritonavir | CAPSULE;ORAL | 020945-001 | Jun 29, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Abbott | NORVIR | ritonavir | CAPSULE;ORAL | 020680-001 | Mar 1, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | NORVIR | ritonavir | SOLUTION;ORAL | 020659-001 | Mar 1, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | NORVIR | ritonavir | SOLUTION;ORAL | 020659-001 | Mar 1, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NORVIR
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Mylan S.A.S | Ritonavir Mylan | ritonavir | EMEA/H/C/004549 Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV 1 infected patients (adults and children of 2 years of age and older). |
Authorised | yes | no | no | 2017-11-09 | |
| AbbVie Deutschland GmbH Co. KG | Norvir | ritonavir | EMEA/H/C/000127 Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older). |
Authorised | no | no | no | 1996-08-25 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for NORVIR
See the table below for patents covering NORVIR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 392895 | ⤷ Sign Up | |
| Taiwan | 200716119 | A solid pharmaceutical dosage formulation | ⤷ Sign Up |
| Peru | 20061016 | UNA FORMULACION SOLIDA DE DOSIFICACION FARMACEUTICA | ⤷ Sign Up |
| Hungary | E038073 | ⤷ Sign Up | |
| Japan | 2006232845 | RETROVIRAL PROTEASE-INHIBITING COMPOUND | ⤷ Sign Up |
| Japan | 2012111775 | USE OF RITONAVIR (ABT-538) FOR IMPROVING PHARMACOKINETIC OF DRUG METABOLIZED BY CYTOCHROME P450 IN METHOD OF TREATING AIDS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NORVIR
| 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 |
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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