LEXIVA Drug Patent Profile
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When do Lexiva patents expire, and when can generic versions of Lexiva launch?
Lexiva is a drug marketed by Viiv Hlthcare and is included in two NDAs.
The generic ingredient in LEXIVA is fosamprenavir calcium. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lexiva
A generic version of LEXIVA was approved as fosamprenavir calcium by MYLAN on April 15th, 2016.
Summary for LEXIVA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 12 |
| Patent Applications: | 510 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LEXIVA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEXIVA |
| What excipients (inactive ingredients) are in LEXIVA? | LEXIVA excipients list |
| DailyMed Link: | LEXIVA at DailyMed |
Recent Clinical Trials for LEXIVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical College of Wisconsin | Phase 3 |
| ViiV Healthcare | Phase 1 |
| GlaxoSmithKline | Phase 1 |
Pharmacology for LEXIVA
| Drug Class | Protease Inhibitor |
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors P-Glycoprotein Inducers |
Anatomical Therapeutic Chemical (ATC) Classes for LEXIVA
Paragraph IV (Patent) Challenges for LEXIVA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LEXIVA | Tablets | fosamprenavir calcium | 700 mg | 021548 | 1 | 2012-01-18 |
US Patents and Regulatory Information for LEXIVA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | LEXIVA | fosamprenavir calcium | SUSPENSION;ORAL | 022116-001 | Jun 14, 2007 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Viiv Hlthcare | LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548-001 | Oct 20, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 LEXIVA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548-001 | Oct 20, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | LEXIVA | fosamprenavir calcium | SUSPENSION;ORAL | 022116-001 | Jun 14, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | LEXIVA | fosamprenavir calcium | TABLET;ORAL | 021548-001 | Oct 20, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEXIVA
See the table below for patents covering LEXIVA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 4282639 | ⤷ Try a Trial | |
| Eurasian Patent Organization | 003509 | СУЛЬФОНАМИДНЫЕ ПРОИЗВОДНЫЕ В КАЧЕСТВЕ ПРОЛЕКАРСТВ, ИНГИБИТОРОВ АСПАРТИЛПРОТЕАЗ (SULPHONAMIDE DERIVATIVES AS PRODRUGS OF ASPARTYL PROTEASE INHIBITORS) | ⤷ Try a Trial |
| Germany | 69904600 | ⤷ Try a Trial | |
| China | 1284071 | ⤷ Try a Trial | |
| Croatia | P20010046 | ⤷ Try a Trial | |
| Morocco | 26660 | ⤷ Try a Trial | |
| Norway | 2009008 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEXIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0933372 | 08C0015 | France | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712 |
| 0933372 | PA2008006,C0933372 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
| 0933372 | 324 | Finland | ⤷ Try a Trial | |
| 0933372 | 300339 | Netherlands | ⤷ Try a Trial | 300339, 20180310, EXPIRES: 20190711 |
| 0933372 | C00933372/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56706 17.03.2005 |
| 0933372 | 91426 | Luxembourg | ⤷ Try a Trial | 91426, EXPIRES: 20190712 |
| 0933372 | CA 2008 00027 | Denmark | ⤷ Try a Trial | |
| >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.
ISSN: 2162-2639
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