DrugPatentWatch Database Preview
Cephalon Company Profile
What is the competitive landscape for CEPHALON, and when can generic versions of CEPHALON drugs launch?
There are twenty-six US patents protecting CEPHALON drugs.
There are two hundred and eighty-one patent family members on CEPHALON drugs in thirty-five countries and fourteen supplementary protection certificates in five countries.
Summary for Cephalon
| International Patents: | 281 |
| US Patents: | 26 |
| Tradenames: | 8 |
| Ingredients: | 6 |
| NDAs: | 8 |
Drugs and US Patents for Cephalon
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cephalon | NUVIGIL | armodafinil | TABLET;ORAL | 021875-004 | Jun 15, 2007 | AB | RX | Yes | Yes | 7,132,570*PED | ➤ Sign Up | Y | ➤ Sign Up | ||
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-001 | Sep 25, 2006 | RX | Yes | No | 8,753,611 | ➤ Sign Up | ➤ Sign Up | ||||
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-004 | Sep 30, 1997 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-008 | Nov 29, 2005 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Expired US Patents for Cephalon
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-001 | Nov 4, 1998 | 4,671,953 | ➤ Sign Up |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-005 | Apr 16, 1999 | 5,866,590 | ➤ Sign Up |
| Cephalon | FENTANYL | fentanyl citrate | TROCHE/LOZENGE;ORAL | 020195-007 | Oct 30, 1995 | 4,671,953 | ➤ Sign Up |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-005 | Apr 16, 1999 | 5,958,951 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for CEPHALON drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Buccal Tablets | 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg | ➤ Subscribe | 2007-11-13 |
| ➤ Subscribe | Lozenges | 0.4 mg | ➤ Subscribe | 2004-10-06 |
| ➤ Subscribe | Lozenges | 0.8 mg, 1.2 mg and 1.6 mg | ➤ Subscribe | 2004-11-22 |
| ➤ Subscribe | Tablets | 50 mg, 150 mg and 250 mg | ➤ Subscribe | 2009-07-24 |
| ➤ Subscribe | Injection | 25 mg/vial and 100 mg/vial | ➤ Subscribe | 2013-06-04 |
| ➤ Subscribe | Injection | 90 mg/mL, 0.5 mL and 2 mL in single-dose vials | ➤ Subscribe | 2014-06-19 |
| ➤ Subscribe | Lozenges | 0.2 mg | ➤ Subscribe | 2004-10-29 |
| ➤ Subscribe | Lozenges | 0.6 mg | ➤ Subscribe | 2004-12-20 |
| ➤ Subscribe | Tablets | 2 mg and 4 mg | ➤ Subscribe | 2005-02-01 |
| ➤ Subscribe | Tablets | 100 mg and 200 mg | ➤ Subscribe | 2009-09-11 |
| ➤ Subscribe | Tablets | 12 mg and 16 mg | ➤ Subscribe | 2014-01-24 |
| ➤ Subscribe | Injection | 1 mg/mL | ➤ Subscribe | 2015-08-11 |
Non-Orange Book US Patents for Cephalon
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 |
|---|---|---|
| 6,509,036 | Effervescent drug delivery system for oral administration | ➤ Sign Up |
| 6,576,250 | Pharmaceutical compositions for rectal and vaginal administration | ➤ Sign Up |
| 6,641,838 | Effervescent drug delivery system for oral administration | ➤ Sign Up |
| 8,298,577 | Effervescent oral opiate dosage forms and methods of administering opiates | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Cephalon Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Canada | 2569674 | ➤ Sign Up |
| Mexico | PA06007453 | ➤ Sign Up |
| Brazil | PI0418228 | ➤ Sign Up |
| Australia | 2004311879 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Cephalon Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2006000022 | Germany | ➤ Sign Up | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| 00523 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
| 0653 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
| 2006 00019 | Denmark | ➤ Sign Up | PRODUCT NAME: FENTANYL HYDROCHLORID |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
