Navigation Links
Cephalon Notified of Generic Fentanyl Buccal Tablet Filing

FRAZER, Pa., April 24 /PRNewswire-FirstCall/ -- Cephalon, Inc., (Nasdaq: CEPH) today announced its receipt of a Paragraph IV Certification Notice Letter relating to an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Watson Laboratories, Inc., requesting approval to market and sell a generic version of FENTORA(R) (fentanyl buccal tablet) [C-II]. In its Notice Letter, Watson alleges that the U.S. Patent Numbers 6,200,604 and 6,974,590 covering FENTORA are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA.

Cephalon currently is reviewing the Notice Letter and, by statute, has 45 days to initiate a patent infringement lawsuit against Watson. Such a lawsuit would automatically prevent the FDA from approving the Watson ANDA until the earlier of a district court decision or 30 months from the company's receipt of the Notice Letter.

Cephalon has a three-year period of marketing exclusivity for FENTORA that extends until September 2009. Additionally, the method of use patents described above expire in 2019.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The company's European headquarters are located in Maisons-Alfort, France.

The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], TREANDA(R) (bendamustine hydrochloride), FENTORA, TRISENOX(R) (arsenic trioxide) injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at or by calling 1-800- 896-5855.

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; legal matters, including whether the company will initiate a patent infringement lawsuit against Watson; market prospects for its products; sales, adjusted net income and basic adjusted income per common share guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

SOURCE Cephalon, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Cephalon, Inc. Announces Agreement to Acquire AMRIX, A Once-Daily Extended-Release Muscle Relaxant
3. Cephalon Reinforces Important Prescribing and Dosing Information for FENTORA
4. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
5. Cephalon Quarterly Conference Call Invitation
6. Cephalon Announces Strong Third Quarter Financial Results
7. Cephalon Submits Supplemental New Drug Application for FENTORA
8. Cephalon Submits New Drug Application for TREANDA for the Treatment of Patients with Relapsed Indolent Non-Hodgkins Lymphoma
9. Cephalon Presentation Slides for the 26th Annual JPMorgan Healthcare Conference Now Available
10. Cephalons EFFENTORA Receives Positive Opinion from European Regulatory Authorities for the Management of Breakthrough Cancer Pain
11. Cephalon Provides Update on Regulatory Status of the FENTORA Supplemental New Drug Application
Post Your Comments:
(Date:11/24/2015)... ... November 24, 2015 , ... The United States Golf Association ... 2016 USGA Green Section Award. Presented annually since 1961, the USGA Green Section Award ... work with turfgrass. , Clarke, of Iselin, N.J., is an extension specialist ...
(Date:11/24/2015)... , Nov. 24, 2015 /CNW/ - iCo Therapeutics ... today reported financial results for the quarter ended ... expressed in Canadian dollars and presented under International ... United States ," said Andrew Rae ... advancements regarding iCo-008 are not only value enriching ...
(Date:11/24/2015)... , Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. ... IIROC on behalf of the Toronto Stock Exchange, confirms ... there are no corporate developments that would cause the ... --> --> About Aeterna Zentaris ... . --> Aeterna Zentaris is a specialty ...
(Date:11/24/2015)... ... 24, 2015 , ... This fall, global software solutions leader SAP and AdVenture ... develop and pitch their BIG ideas to improve health and wellness in their schools. ... to win the title of SAP's Teen Innovator, an all-expenses paid trip to Super ...
Breaking Biology Technology:
(Date:10/29/2015)... , Oct. 29, 2015  Connected health pioneer, ... the explosion of technology-enabled health and wellness, and the ... book, The Internet of Healthy Things ... or smartphones even existed, Dr. Kvedar, vice president, Connected ... health care delivery, moving care from the hospital or ...
(Date:10/27/2015)... SAN JOSE, Calif. , Oct. 27, 2015 /PRNewswire/ ... human interface solutions, today announced that Google has adopted ... family of touch controller solutions to power its newest ... Nexus 6P by Huawei. --> ... ecosystem partners like Google to provide strategic collaboration in ...
(Date:10/23/2015)... GOLETA, California , October 23, 2015 ... and SensoMotoric Instruments (SMI) announce a mobile plug and ... captured during interactive real-world tasks SensoMotoric Instruments ... of their established wearable solutions for eye tracking and ... behavior captured with SMI Eye Tracking Glasses 2w ...
Breaking Biology News(10 mins):