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Last Updated: June 29, 2022

ODEFSEY Drug Patent Profile


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When do Odefsey patents expire, and when can generic versions of Odefsey launch?

Odefsey is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and thirty-one patent family members in fifty-six countries.

The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Odefsey

Odefsey was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 15, 2033. This may change due to patent challenges or generic licensing.

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.

Indicators of Generic Entry

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Drug patent expirations by year for ODEFSEY
Drug Prices for ODEFSEY

See drug prices for ODEFSEY

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ODEFSEY
Generic Entry Date for ODEFSEY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for ODEFSEY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ODEFSEY Tablets emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate 200 mg/25 mg/ 25 mg 208351 3 2019-11-05

US Patents and Regulatory Information for ODEFSEY

ODEFSEY is protected by seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ODEFSEY is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ODEFSEY

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Prodrugs of phosphonate nucleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of phosphonate nucoleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 ODEFSEY

International Patents for ODEFSEY

When does loss-of-exclusivity occur for ODEFSEY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 39
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 7546
Estimated Expiration: See Plans and Pricing

Australia

Patent: 12296622
Estimated Expiration: See Plans and Pricing

Patent: 14271320
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014003420
Estimated Expiration: See Plans and Pricing

Canada

Patent: 45553
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14000370
Estimated Expiration: See Plans and Pricing

China

Patent: 3732594
Estimated Expiration: See Plans and Pricing

Patent: 0343135
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 80063
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140072
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0161696
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18385
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 44810
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 14013206
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7768
Estimated Expiration: See Plans and Pricing

Patent: 1490208
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 44810
Estimated Expiration: See Plans and Pricing

Patent: 70088
Estimated Expiration: See Plans and Pricing

Patent: 31832
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 99026
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31253
Estimated Expiration: See Plans and Pricing

India

Patent: 12DEN2014
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0949
Estimated Expiration: See Plans and Pricing

Patent: 0649
Estimated Expiration: See Plans and Pricing

Japan

Patent: 51275
Estimated Expiration: See Plans and Pricing

Patent: 56537
Estimated Expiration: See Plans and Pricing

Patent: 80162
Estimated Expiration: See Plans and Pricing

Patent: 14528924
Estimated Expiration: See Plans and Pricing

Patent: 15038149
Estimated Expiration: See Plans and Pricing

Patent: 16169228
Estimated Expiration: See Plans and Pricing

Patent: 18065870
Estimated Expiration: See Plans and Pricing

Patent: 20040972
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 44810
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6627
Estimated Expiration: See Plans and Pricing

Patent: 14001549
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 08
Estimated Expiration: See Plans and Pricing

Patent: 140011
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 612
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 350
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0421
Estimated Expiration: See Plans and Pricing

Peru

Patent: 141328
Estimated Expiration: See Plans and Pricing

Poland

Patent: 44810
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 44810
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600476
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 353
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 14011548
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 44810
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1400582
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1612642
Estimated Expiration: See Plans and Pricing

Patent: 140054068
Estimated Expiration: See Plans and Pricing

Spain

Patent: 08871
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 16499
Estimated Expiration: See Plans and Pricing

Patent: 1321396
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5311
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 262
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ODEFSEY around the world.

Country Patent Number Title Estimated Expiration
Norway 20040633 See Plans and Pricing
Hungary S1600059 See Plans and Pricing
Hungary 0301307 See Plans and Pricing
Denmark 0984013 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ODEFSEY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 122016000108 Germany See Plans and Pricing PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1419152 SPC/GB12/025 United Kingdom See Plans and Pricing PRODUCT NAME: A COMBINATION OF RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE.; REGISTERED: UK EU/1/11/737/001 20111128
1663240 132016000129162 Italy See Plans and Pricing PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME UN SALE FARMACEUTICAMENTE ACCETTABILE DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, EMTRICITABINA, E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623
1419152 22/2012 Austria See Plans and Pricing PRODUCT NAME: KOMBINATION VON RILPIVIRIN UND PHARMAZEUTISCH ANNEHMBAREN ADDITIONSSALZEN VON RILPIVIRIN, EINSCHLIESSLICH DEM HYDROCHLORID VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
Mallinckrodt
Colorcon
McKinsey
Harvard Business School

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.