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Generated: September 20, 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 | 3 |
| Clinical Trials: see list | 8 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | COMPLERA at DailyMed |
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| 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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,914,400 | Method and compositions for the synthesis of BCH-189 and related compounds | ► Subscribe | |||||||||||||||||||||||||||
| 7,053,100 | Therapeutic nucleosides | ► Subscribe | |||||||||||||||||||||||||||
| 6,069,252 | Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers | ► Subscribe | |||||||||||||||||||||||||||
| 6,812,233 | Therapeutic nucleosides | ► Subscribe | |||||||||||||||||||||||||||
| 9,580,392 | HIV replication inhibiting pyrimidines | ► Subscribe | |||||||||||||||||||||||||||
| 5,204,466 | Method and compositions for the synthesis of BCH-189 and related compounds | ► 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 | |||||||||||||||||||||||||||
| 7,160,999 | Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers | ► Subscribe | |||||||||||||||||||||||||||
| 7,468,436 | Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers | ► Subscribe | |||||||||||||||||||||||||||
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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.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2014203484 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 122005000041 | ► Subscribe | |||||||||||||||||||||||||||
| African Regional IP Organization (ARIPO) | 2487 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | 0108879 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 150920 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20110132475 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4496377 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 9804569 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 9201251 | ► Subscribe | |||||||||||||||||||||||||||
| China | 104586850 | ► Subscribe | |||||||||||||||||||||||||||
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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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 12/017 | Ireland | ► Subscribe | PRODUCT NAME: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT THEREOF, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE; REGISTRATION NO/DATE: EU/1/11/736/001 20111128 | ||||||||||||||||||||||||||
| 90017-1 | Sweden | ► Subscribe | PRODUCT NAME: RILPIVIRIN OCH FARMACEUTISKT GODTAGBARA ADDITIONSSALTER DAERAV, INBEGRIPET VAETEKLORSYRASALTET AV RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128 | ||||||||||||||||||||||||||
| 2015000087 | Germany | ► Subscribe | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 | ||||||||||||||||||||||||||
| 0120010 00057 | Estonia | ► Subscribe | PRODUCT NAME: EDURANT - RILPIVIRIIN;REG NO/DATE: C(2011)8955 FINAL 28.11.2011 | ||||||||||||||||||||||||||
| C0071 | France | ► Subscribe | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 | ||||||||||||||||||||||||||
| 2016043 | Lithuania | ► Subscribe | PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 | ||||||||||||||||||||||||||
| C0020 | France | ► Subscribe | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 | ||||||||||||||||||||||||||
| 0851 | Netherlands | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2015000088 | Germany | ► Subscribe | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 | ||||||||||||||||||||||||||
| 2016 00066 | Denmark | ► Subscribe | PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623 | ||||||||||||||||||||||||||
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Export unavailable in trial.
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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.
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