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Generated: July 25, 2017
What is the competitive landscape for JANSSEN PRODS, and when can generic versions of JANSSEN PRODS drugs launch?
JANSSEN PRODS has six approved drugs.| Patents: | 25 |
| Tradenames: | 5 |
| Ingredients: | 5 |
| NDAs: | 6 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Prods | PREZISTA | darunavir ethanolate | TABLET;ORAL | 021976-002 | Feb 25, 2008 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Janssen Prods | PREZISTA | darunavir ethanolate | TABLET;ORAL | 021976-003 | Oct 21, 2008 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Janssen Prods | PREZISTA | darunavir ethanolate | SUSPENSION;ORAL | 202895-001 | Dec 16, 2011 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Janssen Prods | OLYSIO | simeprevir sodium | CAPSULE;ORAL | 205123-001 | Nov 22, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Prods | PREZISTA | darunavir ethanolate | SUSPENSION;ORAL | 202895-001 | Dec 16, 2011 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Janssen Prods | PREZISTA | darunavir ethanolate | TABLET;ORAL | 021976-005 | Dec 18, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Janssen Prods | PREZISTA | darunavir ethanolate | TABLET;ORAL | 021976-004 | Dec 18, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Janssen Prods | PREZISTA | darunavir ethanolate | TABLET;ORAL | 021976-001 | Jun 23, 2006 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Janssen Prods | PREZISTA | darunavir ethanolate | TABLET;ORAL | 021976-003 | Oct 21, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
darunavir ethanolate | Tablets | 800 mg | PREZISTA | 5/14/2013 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,486,942 | Modulators of pharmacokinetic properties of therapeutics | ► Subscribe | |||||||||||||||||||||||||||
| 7,956,063 | Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile | ► Subscribe | |||||||||||||||||||||||||||
| 7,939,553 | Modulators of pharmacokinetic properties of therapeutics | ► Subscribe | |||||||||||||||||||||||||||
| 9,139,541 | Modulators of pharmacokinetic properties of therapeutics | ► Subscribe | |||||||||||||||||||||||||||
| 9,580,392 | HIV replication inhibiting pyrimidines | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Luxembourg | 92855 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 334877 | ► Subscribe | |||||||||||||||||||||||||||
| Serbia | 50510 | ► Subscribe | |||||||||||||||||||||||||||
| Lithuania | 2487162 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 1419152 | ► 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.
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Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0850 | 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; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 | ||||||||||||||||||||||||||
| C0078 | France | ► Subscribe | PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 2 5010-2012 | Slovakia | ► Subscribe | PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128 | ||||||||||||||||||||||||||
| 00532 | Netherlands | ► Subscribe | PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE EN ELKE DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN,; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 | ||||||||||||||||||||||||||
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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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