truvada Drug Patent Profile
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When do Truvada patents expire, and what generic alternatives are available?
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.
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Questions you can ask:
- What is the 5 year forecast for truvada?
- What are the global sales for truvada?
- What is Average Wholesale Price for truvada?
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 |
![truvada drug patent expirations Drug patent expirations by year for truvada](/p/graph/s/t/truvada-patent-expirations.png)
![Drug Prices for truvada](/p/graph/drug-price/truvada.png)
![Drug Sales Revenue Trends for truvada](/p/graph/drug-sales-revenues/truvada.png)
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION
Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-003 | Mar 10, 2016 | AB | RX | Yes | No | ⤷ 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 truvada
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-003 | Mar 10, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-004 | Mar 10, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>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 Korea | 100381705 | ⤷ Sign Up | |
Hong Kong | 1026419 | ⤷ Sign Up | |
Germany | 122004000015 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for truvada
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0513200 | 7/2004 | Austria | ⤷ Sign Up | 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 | SPC/GB15/064 | United Kingdom | ⤷ Sign Up | 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 |
3808743 | 2022C/531 | Belgium | ⤷ Sign Up | PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |