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Generated: August 17, 2017
What is the competitive landscape for CEPHALON, and when can generic versions of CEPHALON drugs launch?
CEPHALON has eight approved drugs.| Patents: | 27 |
| Tradenames: | 8 |
| Ingredients: | 6 |
| NDAs: | 8 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-003 | Sep 30, 1997 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cephalon | TREANDA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 022249-004 | Sep 13, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | AP | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | AP | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-004 | Sep 30, 1997 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cephalon | PROVIGIL | modafinil | TABLET;ORAL | 020717-002 | Dec 24, 1998 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-002 | Nov 4, 1998 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-001 | Jun 15, 2007 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cephalon | FENTANYL | fentanyl citrate | TROCHE/LOZENGE;ORAL | 020195-007 | Oct 30, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
arsenic trioxide | Injection | 1 mg/mL | TRISENOX | 8/11/2015 |
bendamustine hydrochloride | Injection | 90 mg/mL, 0.5 mL and 2 mL in single-dose vials | TREANDA | 6/19/2014 |
tiagabine hydrochloride | Tablets | 12 mg and 16 mg | GABITRIL | 1/24/2014 |
bendamustine hydrochloride | Injection | 25 mg/vial and 100 mg/vial | TREANDA | 6/4/2013 |
armodafinil | Tablets | 100 mg and 200 mg | NUVIGIL | 9/11/2009 |
fentanyl citrate | Buccal Tablets | 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg | FENTORA | 11/13/2007 |
tiagabine hydrochloride | Tablets | 2 mg and 4 mg | GABITRIL | 2/1/2005 |
fentanyl citrate | Lozenges | 0.6 mg | ACTIQ | 12/20/2004 |
fentanyl citrate | Lozenges | 0.8 mg, 1.2 mg and 1.6 mg | ACTIQ | 11/22/2004 |
fentanyl citrate | Lozenges | 0.2 mg | ACTIQ | 10/29/2004 |
fentanyl citrate | Lozenges | 0.4 mg | ACTIQ | 10/6/2004 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,298,577 | Effervescent oral opiate dosage forms and methods of administering opiates | ► Subscribe | |||||||||||||||||||||||||||
| 6,764,696 | Effervescent drug delivery system for oral administration | ► Subscribe | |||||||||||||||||||||||||||
| 6,350,470 | Effervescent drug delivery system for oral administration | ► Subscribe | |||||||||||||||||||||||||||
| 8,802,130 | Sublingual buccal effervescent | ► Subscribe | |||||||||||||||||||||||||||
| 6,509,036 | Effervescent drug delivery system for oral administration | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mexico | 339878 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2009120386 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2383478 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1091732 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 295578 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0653 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 | ||||||||||||||||||||||||||
| 00521 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 | ||||||||||||||||||||||||||
| C/GB06/022 | United Kingdom | ► Subscribe | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 | ||||||||||||||||||||||||||
| C0107 | Belgium | ► Subscribe | PRODUCT NAME: TIAGABINE CHLORHYDRATE MONOHYDRATE - TIAGABINE ANHYDRE; NAT. REGISTRATION NO/DATE: 403 IS 102 F 3 19970602; FIRST REGISTRATION: FR 341 260.2 19960614 | ||||||||||||||||||||||||||
| 00523 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 | ||||||||||||||||||||||||||
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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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