Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: July 22, 2017
What is the patent landscape for Complera, and what generic Complera alternatives are available?
Complera is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.| Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Clinical Trials: see list | 8 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | COMPLERA at DailyMed |
Export unavailable in trial.
Subscribe for complete access.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | 5,814,639*PED | ► Subscribe | ||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| emtricitabine, rilpivirine, and tenofovir disoproxil fumarate | Tablets | 200 mg/25 mg/300 mg | Complera | 5/20/2015 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,069,252 | Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers | ► Subscribe | |||||||||||||||||||||||||||
| 7,402,588 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane | ► Subscribe | |||||||||||||||||||||||||||
| 5,700,937 | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds | ► Subscribe | |||||||||||||||||||||||||||
| RE38333 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability | ► Subscribe | |||||||||||||||||||||||||||
| 5,728,575 | Method of resolution of 1,3-oxathiolane nucleoside enantiomers | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India | 190780 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | S1600060 | ► Subscribe | |||||||||||||||||||||||||||
| Romania | 108564 | ► Subscribe | |||||||||||||||||||||||||||
| Finland | 116222 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20071745 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 008 | Luxembourg | ► Subscribe | 92008, EXPIRES: 20261128 | ||||||||||||||||||||||||||
| 854 | Luxembourg | ► Subscribe | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE, ET TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL | ||||||||||||||||||||||||||
| 2015 00055 | Denmark | ► Subscribe | PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128 | ||||||||||||||||||||||||||
| 0768 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 | ||||||||||||||||||||||||||
| 2016 00064 | Denmark | ► Subscribe | PRODUCT NAME: RILPIVIRINHYDROCHLORID, EMTRICITABIN OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623 | ||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
Follow DrugPatentWatch:
Join the 22,067 other biopharmaceutical professionals who get our Drug Patent Expiration Alerts:
