ATRIPLA Drug Patent Profile
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When do Atripla patents expire, and what generic alternatives are available?
Atripla is a drug marketed by Gilead Sciences and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-three patent family members in thirty-one countries.
The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.
DrugPatentWatch® Generic Entry Outlook for Atripla
Atripla was eligible for patent challenges on July 2, 2007.
There have been eighteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are two tentative approvals for the generic drug (efavirenz; emtricitabine; tenofovir disoproxil fumarate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for ATRIPLA
| International Patents: | 123 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 54 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ATRIPLA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ATRIPLA |
| What excipients (inactive ingredients) are in ATRIPLA? | ATRIPLA excipients list |
| DailyMed Link: | ATRIPLA at DailyMed |
Recent Clinical Trials for ATRIPLA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Willem Daniel Francois Venter | Phase 1 |
| University of Cape Town | Phase 1 |
| Yu-Jay Corp. | Phase 3 |
Pharmacology for ATRIPLA
Anatomical Therapeutic Chemical (ATC) Classes for ATRIPLA
Paragraph IV (Patent) Challenges for ATRIPLA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ATRIPLA | Tablets | efavirenz; emtricitabine; tenofovir disoproxil fumarate | 600 mg/200 mg/300 mg | 021937 | 1 | 2008-12-29 |
US Patents and Regulatory Information for ATRIPLA
ATRIPLA is protected by ten US patents.
Patents protecting ATRIPLA
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS
Unitary pharmaceutical dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Unitary pharmaceutical dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS
Unitary pharmaceutical dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Unitary pharmaceutical dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Unitary pharmaceutical dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 ATRIPLA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ATRIPLA
See the table below for patents covering ATRIPLA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Singapore | 106656 | NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD | ⤷ Try a Trial |
| New Zealand | 564102 | Stable fixed-dose unitary formulations containing tenofovir, a surfactant, efavirenz and emtricitabine | ⤷ Try a Trial |
| Norway | 932980 | ⤷ Try a Trial | |
| South Korea | 20000070735 | ⤷ Try a Trial | |
| Japan | 4496377 | ⤷ Try a Trial | |
| New Zealand | 564045 | Stable fixed-dose formulations containing a combination of antivirals (emtricitabine and tenofovir DF), method for producing thereof using dry granulation | ⤷ Try a Trial |
| Australia | 1561792 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ATRIPLA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0582455 | CA 2008 00026 | Denmark | ⤷ Try a Trial | |
| 0915894 | SPC018/2008 | Ireland | ⤷ Try a Trial | SPC018/2008: 20090811, EXPIRES: 20220724 |
| 0513200 | 91073 | Luxembourg | ⤷ Try a Trial | 91073, EXPIRES: 20160131 |
| 0915894 | 91433 | Luxembourg | ⤷ Try a Trial | 91433, EXPIRES: 20220725 |
| 0582455 | 40/2000 | Austria | ⤷ Try a Trial | PRODUCT NAME: EFAVIRENZ, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/99/110/001-004 1/99/111/001-004 19990528; FIRST REGISTRATION: LI 54908 01, 54908 02, 54908 03 19981120 |
| 0582455 | SPC029/2000 | Ireland | ⤷ Try a Trial | SPC029/2000: 20050912, EXPIRES: 20131119 |
| 0582455 | 91446 | Luxembourg | ⤷ Try a Trial | 91446, EXPIRES: 20180803 |
| >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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