Generics Industry News Search
 |
|
|
|
|
|
|
January 2008 News Archive |
|
|
| |
|
/Patent Docs Blog/ January 01, 2008 By Donald Zuhn -- Yesterday, we counted down stories #10 to #6 of the top stories covered at Patent Docs in 2007. Today, we conclude the series by counting down the top five stories. In case you missed the articles the first time around or wish to go back and review them at your convenience, links to our coverage of these stories (as well as a few links to articles on related topics) have been provided....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
CORONA, Calif., January 02, 2008 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution in the 0.5 mg/3 mg strength....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
ESPOO, Finland, Jan. 2, 2008--Orion Corporation has been informed that Sun Pharmaceutical Industries Ltd., India (Sun), has amended its Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market generic versions of Stalevo® tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) in the United States. Sun's amendment to its ANDA involves a Paragraph IV challenge to Orion's U.S. Patent No. 5,446,194. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
MONTVALE, N.J., January 02, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Encysive Pharmaceuticals in connection with its Argatroban(R) Injection (argatroban) 100mg/mL, 2.5mL vial. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
MONTVALE, N.J., Jan. 2, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s Kytril (granisetron hydrochloride) Tablets, 1mg (eq to 1 mg base). The Company received final approval following the expiration of Roche's patent on December 28, 2007, and plans to launch its product shortly....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
JERUSALEM--(BUSINESS WIRE)--Jan 2, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Dey's bronchodilator, DuoNeb(R) (Albuterol Sulfate and Ipratropium Bromide) Inhalation Solution, 3 mg (0.083%) and 0.5 mg (0.017%). Shipment of the product will begin immediately....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
COLUMBUS, Ohio, January 02, 2008 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride Tablets, 1mg by the U.S. Food and Drug Administration. The product is available in Unit Dose Blisters and is available for immediate shipment to wholesalers and pharmacies nationwide....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
COLUMBUS, Ohio, January 02, 2008 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Balsalazide Disodium Capsules, 750mg by the U.S. Food and Drug Administration. The product is available in bottles of 280 capsules for immediate shipment to wholesalers and pharmacies nationwide....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
JERUSALEM--(BUSINESS WIRE)--Jan 3, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Applications (ANDA) to market its generic version of Roche's antinauseant and antiemetic agent Kytril(R) (Granisetron Hydrochloride) Injection, 1 mg (base)/mL in 1 mL single-dose vials and 1 mg (base) Tablets....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
CORONA, Calif., January 03, 2008 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today it has launched Clarithromycin Extended-Release Tablets, USP in the 500 mg strength....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
NEW YORK--(BUSINESS WIRE)--Jan 3, 2008 - Pfizer Inc said today it will appeal a Canadian Federal Court decision in favor of generic manufacturer Apotex in its challenge to a Pfizer patent covering Lipitor. ... The court's decision has no immediate commercial impact because Lipitor is protected by other patents in Canada, which also are the subject of pending legal challenges.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
BOSTON, Jan. 4, 2008 -- Putnam Associates, a Boston-based strategy consulting firm serving the biotechnology and pharmaceutical industries globally, released today a report on how innovators are increasingly feeling constrained by the generic industry well in advance of their products’ patent expiry due to a variety of challenges that threaten to shorten the branded lifecycle. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ January 06, 2008 By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week: Aventis v. Hospira (enoxaparin); Sciele v. Mylan (nisoldipine); Duramed v. Sandoz (estrogen & progestin); Duramed v. Watson (estrogen & progestin); Pfizer v. Teva (tolterodine); Novartis v. Mylan (amlodipine)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Financial Times/ January 7 2008 -- A cut of 10 per cent in the prices the NHS pays for prescription medicines is being sought by the government in a deal it plans to conclude with the pharmaceutical industry by the middle of the year. Alan Johnson, the health minister, told the Financial Times that he planned to generate substantial savings in the drugs budget during talks to be completed by June on the Pharmaceutical Price Regulation Scheme, the agreement that covers the price to the NHS of branded drugs. Government officials are believed to have staked out an initial position with industry to cut the £11bn annual medicines bill by at least 10 per cent, or about £1bn. Click here to read full article (www.ft.com)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
BOCA RATON, Fla., January 07, 2008 /PRNewswire/ -- Breckenridge announced today that it has entered into an agreement with Helm AG to develop and manufacture a generic tablet ANDA product. Breckenridge expects to file an ANDA with the FDA in January 2008. Upon approval by the FDA, Helm AG will supply and Breckenridge will market and distribute the product on an exclusive basis....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ January 07, 2008 By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
EDISON, N.J., January 08, 2008 /PRNewswire/ -- Heritage Pharmaceuticals Inc. ("Heritage") and Banner Pharmacaps Inc. ("Banner") announced today that they have entered into a licensing and supply agreement for multiple generic, pharmaceutical softgel products for the U.S. prescription drug market....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
EXTON, Pa., January 08, 2008 /PRNewswire-FirstCall/ -- ViroPharma Incorporated today provided the following update on its petition to the U.S. Food and Drug Administration (FDA) regarding Vancocin(R) (vancomycin hydrochloride capsules). "As part of the company's continuing efforts to assure the safety of patients afflicted with Clostridium difficile infection, ViroPharma yesterday presented its views on the in vitro dissolution bioequivalence method proposed by OGD...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Jan 9, 2008 - Taro Pharmaceutical Industries Ltd. ("Taro," Pink Sheets: TAROF) reported today that it settled a pending lawsuit with Novartis and will be launching Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg ("Oxcarbazepine Tablets") in the United States....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
NUTLEY, N.J., January 09, 2008 /PRNewswire/ -- Roche today announced that it has entered into four new technology transfers with local manufacturing companies in African and Asian nations where improvements in access to anti-retroviral therapy are needed. ... these companies will be provided free of charge with the technical expertise to manufacture generic HIV medicine, based upon the processes to produce saquinavir, Roche's second line(1) HIV medicine....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
MONTVALE, N.J., January 09, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, has initiated a challenge of the patents listed by Sanofi-Aventis U.S. LLC in connection with its Eloxatin(R) (Oxaliplatin Aqueous Solution), 5mg/mL Injectable....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
MADISON, Miss.--(BUSINESS WIRE)--Jan 10, 2008 - Cypress Pharmaceutical, Inc., today announced that it has entered into a multiple generic product development and marketing agreement with Standard Chem. & Pharm. Co., Ltd., (TAIWAN:1720), a global pharmaceutical company. The agreement encompasses the development and US commercialization of an estimated 3.4 billion dollars in product market capitalization....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
NEW YORK, January 10, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. , Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co. KgaA, and Merz Pharmaceuticals GmbH announced that they have filed lawsuits in the U.S. District Court for the District of Delaware against several companies for infringement of U.S. Patent No. 5,061,703 (the '703 patent), which relates to Forest's Namenda(R) product....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
MONTVALE, N.J., January 11, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Forest Laboratories, Inc. in connection with its Namenda(R) (memantine hydrochloride) tablets, 5mg and 10mg....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
BOCA RATON, Fla., January 11, 2008 /PRNewswire-FirstCall/ -- Breckenridge Pharmaceutical, Inc. announced today that it settled "Paragraph IV" litigation with Novartis concerning Trileptal(R) and that the U.S. Food and Drug Administration approved Breckenridge's Abbreviated New Drug Application for oxcarbazepine 150mg, 300mg and 600 mg tablets in the United States ("Oxcarbazepine Tablets")....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Orange Book Blog/ January 11, 2008 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ January 13, 2008 By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
NEW YORK--(BUSINESS WIRE)--Jan 14, 2008 - Pfizer Inc announced today that the U.S. Patent & Trademark Office has issued its first communication in the reexamination of the '893 basic patent for Lipitor, initially rejecting the patent's claims. This initial action, which is how the Office raises its issues with the patentee, will now be followed by the company's response, in which Pfizer will address those issues raised by the examiner. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
DETROIT, January 14, 2008 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Glipizide/Metformin Hydrochloride Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg (Glipizide/Metformin HCl)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
JERUSALEM--(BUSINESS WIRE)--Jan 14, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Eisai's Alzheimer's treatment Aricept(R) (Donepezil Hydrochloride) Tablets, 5 mg and 10 mg. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
DETROIT, Jan. 14 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Chewable Tablets, "over-the-counter", (OTC), 5 mg and 10 mg (Cetirizine HCl Chewable)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
HAYWARD, Calif.--(BUSINESS WIRE)--Jan. 15, 2008 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has filed a lawsuit against Medicis Pharmaceutical Corporation in the United States District Court for the Northern District of California requesting a declaration that IMPAX does not infringe any valid claims of U.S. Patent No. 5,908,838 related to IMPAX's filing in October 2007 of an Abbreviated New Drug Application (ANDA) for minocycline hydrochloride extended-release tablets, a generic version of Solodyn(R)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
HOLZKIRCHEN, Germany, January 16, 2008 – Sandoz, the generics division of Novartis, announced today that it was fully cooperating with the European Commission in its investigation of the pharmaceuticals industry. Commission officials were at Sandoz companies in Holzkirchen on January 15....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
AMITYVILLE, N.Y.--(BUSINESS WIRE)--Jan 16, 2008 - Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for fluticasone propionate nasal spray, 50mcg. Hi-Tech's fluticasone propionate nasal spray is the AB-rated generic equivalent of GlaxoSmithKline's Flonase(R)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
SCHAUMBURG, Ill.--(BUSINESS WIRE)--Jan 17, 2008 - APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has launched Granisetron Hydrochloride Injection, 0.1 mg/mL, 1 mL single dose vials, the generic equivalent of Hoffmann-LaRoche's Kytril(R) Injection. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
SCHAUMBURG, Ill.--(BUSINESS WIRE)--Jan 17, 2008 - APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Polymyxin B Sulfate for Injection, USP, 500,000 units/vial, the equivalent of Bedford Laboratories Polymyxin B Sulfate....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
JERUSALEM--(BUSINESS WIRE)--Jan 17, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Pravastatin Sodium Tablets, 80 mg....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Orange Book Blog/ January 17, 2008 -- A reader recently e-mailed me about an interesting citizen petition that Teva filed last August. In the petition, Teva requests that FDA: (1) relist U.S. Patent No. 5,158,952 in the Orange Book for Risperdal (risperidone) tablets; (2) confirm Teva's right to 180-day exclusivity for risperidone tablets; and (3) refrain from approving any other ANDAs for risperidone tablets until Teva's exclusivity expires. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
HAWTHORNE, N.Y., Jan 22, 2008 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (the "Company" or "Taro," Pink Sheets: TAROF) reported today that its U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc. ("Taro USA") has received approval from the U.S. Food and Drug Administration for its New Drug Application (NDA) for Flo-Pred(TM) (prednisolone acetate oral suspension) equivalent to 5 mg/5 mL and 15 mg/5 mL prednisolone in Taro's patent-protected NonSpil(TM) liquid drug delivery system....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Jerusalem, Israel, January 23, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of TAP Pharmaceutical's gastric-acid pump inhibitor, Prevacid® (Lansoprazole) Delayed-release Capsules, 15 mg and 30 mg. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Jerusalem, Israel, January 22, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that it has entered into a definitive agreement to acquire CoGenesys, Inc., a privately-held biopharmaceutical company with a broad based biotechnology platform and focused on the development of peptide- and protein-based medicines across broad therapeutic categories. CoGenesys was established in 2005 as a division within Human Genome Sciences Inc. (HGSI) to focus on early drug development and was spun off as an independent company in June 2006. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
PUBPAT announced on Jan/23 that the U.S. Patent & Trademark Office has rejected [non-final rejections] four key HIV/AIDS drug patents held by Gilead Sciences that relate to tenofovir disoproxil fumarate (TDF). Gilead markets TDF in the United States under the brand name VIREAD and as a part of its ATRIPLA combination product....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Generic drug maker Teva Pharmaceutical Industries Ltd. said Tuesday the company agreed to extend its deal with Wyeth and its partner Altana Pharma AG not to market a generic version of heartburn drug Protonix....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Ranbaxy Laboratories Limited (Ranbaxy) announced today that it has settled all matters relating to possible patent litigation with GlaxoSmithKline relating to Sumatriptan Succinate Tablets, the generic version of GlaxoSmithKline's Imitrex ® Tablets. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva halted its at-risk launch of its generic version of the drug for Gastroesophageal Reflux Disease, Protonix, three days after it was announced at the end of 2007. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
MADISON, MS – Cypress Pharmaceutical, Inc. today announced that it has reached a settlement with Glaxo Group Limited (Glaxo), part of the GlaxoSmithKline group of companies, resolving all disputes between the companies related to Cypress’ generic ranitidine oral solution products and Glaxo’s Zantac® syrup....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
CHADDS FORD, PA and DANBURY, CT, Jan 25, 2008 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Inc., a subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that they have filed a lawsuit against IMPAX Laboratories, Inc. in the United States District Court for the District of Delaware in connection with IMPAX's Abbreviated New Drug Application (ANDA) for OPANA(R) ER (oxymorphone HCl) extended-release tablets CII. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
HYDERABAD, India, Jan. 29, 2008- On January 29, 2008, the FDA granted tentative approval for generic lamivudine tablets, 150 mg and 300 mg, manufactured by Hetero Drugs Limited, Hyderabad, India, for use in combination with other antiretrovirals in the treatment of HIV infection. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
NORTH WALES, Pa., January 31, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Pantoprazole Sodium Delayed-Release Tablets. This product is AB rated and bioequivalent to Protonix®* Delayed-Release Tablets. Pantoprazole Sodium Delayed-Release Tablets are available in 20 mg and 40 mg strengths, in bottle sizes of 90.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
JERUSALEM--(BUSINESS WIRE)--Jan 31, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules, 0.4 mg. Final approval of this product is expected upon expiry of patent protection for the brand product in October 2009. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
|
|
Contribute
If you would like to contribute or publish your
company press releases at GenericsWeb, please
email us.
|
Home
