LEXIVA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Lexiva, 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 |
---|---|---|---|
Netherlands | 300339 | ⤷ Try a Trial | |
Tunisia | SN99145 | CALCIUM (3S) TETRAHYDRO-3-FURANYLE (1S,2R)-3-[[4-AMINOPHENYLE) SULFONYLE] ISOBUTYLE)AMINO]-1-BENZYLE-2-(PHOSPHONOOXY), PROPYLCARBAMATE | ⤷ Try a Trial |
Hungary | 0103432 | ⤷ Try a Trial | |
China | 1324363 | ⤷ Try a Trial | |
Peru | 08692000 | ⤷ Try a Trial | |
Georgia, Republic of | P20032923 | Sulphonamide Derivatives as Prodrugs of Aspartyl Protease Inhibitors, Pharmaceutical compositions containing the Same and Methods for Treatment | ⤷ Try a Trial |
European Patent Office | 0933372 | Dérivés de sulfamides en tant que prodrogues d'inhibiteurs de protéase d'aspartyl (Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors) | ⤷ 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 | 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 | PA2008006,C0933372 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
0933372 | 13/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713 |
0933372 | SPC/GB08/018 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712 |
0933372 | 324 | Finland | ⤷ Try a Trial | |
0933372 | PA2008006 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |