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Generated: July 28, 2017
What is the competitive landscape for JANSSEN PHARMS, and when can generic versions of JANSSEN PHARMS drugs launch?
JANSSEN PHARMS has fifty-six approved drugs.| Patents: | 37 |
| Tradenames: | 54 |
| Ingredients: | 34 |
| NDAs: | 56 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-003 | Oct 29, 2003 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Janssen Pharms | INVOKANA | canagliflozin | TABLET;ORAL | 204042-002 | Mar 29, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-001 | Oct 29, 2003 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-003 | Oct 29, 2003 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-001 | Jul 31, 2009 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-002 | Dec 20, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-003 | Dec 24, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | DURAGESIC-75 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-002 | Aug 7, 1990 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-003 | Oct 29, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-007 | Jan 27, 1999 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
canagliflozin | Tablets | 100 mg and 300 mg | INVOKANA | 3/29/2017 |
canagliflozin andmetforminhydrochloride | Tablets | 50 mg/500 mg, 50mg/1000 mg, 150mg/500 mg, and150 mg/1000 mg | INVOKAMET | 3/29/2017 |
rivaroxaban | Tablets | 10 mg, 15 mg, and 20 mg | XARELTO | 7/1/2015 |
itraconazole | Oral Solution | 10 mg/mL | SPORANOX | 5/3/2013 |
levofloxacin | Oral Solution | 25 mg/mL | LEVAQUIN | 7/30/2009 |
norelgestromin and ethinyl estradiol | Transdermal System | 0.15 mg/0.02 mg per 24 hours | ORTHO EVRA | 3/22/2007 |
galantamine hydrobromide | Extended-release Capsules | 16 mg and 24 mg | RAZADYNE ER | 3/11/2006 |
galantamine hydrobromide | Extended-release Capsules | 8 mg | RAZADYNE ER | 3/2/2006 |
almotriptan malate | Tablets | 6.25 mg and 12.5 mg | AXERT | 12/8/2005 |
topiramate | Tablets | 50 mg | TOPAMAX | 9/8/2005 |
topiramate | Capsules | 15 mg and 25 mg | TOPAMAX SPRINKLE | 9/7/2005 |
methylphenidate hydrochloride | Extended-release Tablets | 18 mg*, 27 mg, 36 mg and 54 mg | CONCERTA | 7/19/2005 |
metformin hydrochloride | Extended-release Tablets | 18 mg, 27 mg, 36 mg and 54 mg | CONCERTA | 7/19/2005 |
risperidone | Orally Disintegrating Tablets | 0.25 mg | RISPERDAL | 4/11/2005 |
risperidone | Orally Disintegrating Tablets | 3 mg and 4 mg | RISPERDAL | 3/23/2005 |
galantamine hydrobromide | Tablets | 4 mg, 8 mg and 12 mg | RAZADYNE | 2/28/2005 |
topiramate | Tablets | 25 mg, 100 mg and 200 mg | TOPAMAX | 12/26/2001 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,129,220 | Substituted indole-O-glucosides | ► Subscribe | |||||||||||||||||||||||||||
| 8,323,691 | Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms | ► Subscribe | |||||||||||||||||||||||||||
| 7,482,330 | Substituted fused heterocyclic C-glycosides | ► Subscribe | |||||||||||||||||||||||||||
| 8,129,378 | Substituted oxazolidinones and their use in the field of blood coagulation | ► Subscribe | |||||||||||||||||||||||||||
| 6,696,091 | Pharmaceutical composition of topiramate | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Argentina | 008237 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | 9908488 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1209098 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20006007 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2379036 | ► 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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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008 00050 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| C0012 | France | ► Subscribe | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 | ||||||||||||||||||||||||||
| 0370 | Netherlands | ► Subscribe | |||||||||||||||||||||||||||
| C/GB98/013 | United Kingdom | ► Subscribe | PRODUCT NAME: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE; REGISTERED: UK 00242/0314 19970923 | ||||||||||||||||||||||||||
| 2016 00016 | Denmark | ► Subscribe | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 | ||||||||||||||||||||||||||
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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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