TRUVADA Drug Patent Profile
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Which patents cover Truvada, and when can generic versions of Truvada launch?
Truvada is a drug marketed by Gilead and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has sixty-two patent family members in twenty-nine countries.
The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Truvada
A generic version of TRUVADA was approved as emtricitabine; tenofovir disoproxil fumarate by TEVA PHARMS USA on June 8th, 2017.
Summary for TRUVADA
| International Patents: | 62 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 227 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRUVADA |
| Drug Sales Revenues: | Drug sales revenues for TRUVADA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRUVADA |
| What excipients (inactive ingredients) are in TRUVADA? | TRUVADA excipients list |
| DailyMed Link: | TRUVADA at DailyMed |
Recent Clinical Trials for TRUVADA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assistance Publique - Hôpitaux de Paris, FRANCE | Phase 3 |
| Ministry of Health, Thailand | Phase 3 |
| Chiang Mai University, Thailand | Phase 3 |
Pharmacology for TRUVADA
Anatomical Therapeutic Chemical (ATC) Classes for TRUVADA
Paragraph IV (Patent) Challenges for TRUVADA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TRUVADA | Tablets | emtricitabine; tenofovir disoproxil fumarate | 100 mg/150 mg 133 mg/200 mg 167 mg/250 mg | 021752 | 1 | 2017-05-19 |
| TRUVADA | Tablets | emtricitabine; tenofovir disoproxil fumarate | 200 mg/300 mg | 021752 | 1 | 2008-09-26 |
US Patents and Regulatory Information for TRUVADA
TRUVADA is protected by six US patents.
Patents protecting TRUVADA
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
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 INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
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 | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-002 | Mar 10, 2016 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-003 | Mar 10, 2016 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | 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 TRUVADA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-002 | Mar 10, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-002 | Mar 10, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-002 | Mar 10, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRUVADA
See the table below for patents covering TRUVADA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Africa | 200505852 | Compositions and methods for combination antiviraltherapy | ⤷ Try a Trial |
| Greece | 950300024 | ⤷ Try a Trial | |
| Ireland | 920545 | ⤷ Try a Trial | |
| Japan | 2017057232 | 組み合わせ抗ウイルス治療のための組成物および方法 (COMPOSITION AND METHOD FOR COMBINATION ANTIVIRAL TREATMENT) | ⤷ Try a Trial |
| Germany | 69130166 | ⤷ Try a Trial | |
| Finland | 121069 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TRUVADA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0915894 | 91433 | Luxembourg | ⤷ Try a Trial | 91433, EXPIRES: 20220725 |
| 1663240 | 1690062-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623 |
| 1632232 | 300852 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
| 1663240 | SPC/GB15/064 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTERED: UK EU/1/11/737/001-002 20111128 |
| 0513200 | 7/2004 | Austria | ⤷ Try a Trial | PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003 |
| 1663240 | 300851 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
| >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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