News

Argentum and Alcon Settle Patent Dispute Over PAZEO®

NEW YORK, November 30, 2016 /PRNewswire/ — Argentum Pharmaceuticals LLC, a generic pharmaceutical company, announced today that it has reached a settlement with Alcon Research, Ltd., related to Argentum’s generic version of PAZEO® (0.7% olopatadine hydrochloride ophthalmic solution).

Under the terms of the settlement agreement, Alcon has granted Argentum a license to its U.S. patent covering PAZEO® for a generic version of PAZEO®. The agreement generally provides that Argentum may commence marketing its generic equivalent product sometime prior to the expiration of the patents covering PAZEO®. The specific date on which Argentum may launch its generic product and other details concerning the settlement have not been disclosed.

PAZEO® is a registered trademark of Novartis AG Corporation.

http://www.prnewswire.com/news-releases/argentum-and-alcon-settle-patent-dispute-over-pazeo-300370728.html

Argentum Pharmaceuticals Succeeds in Starting Patent Cancellation Trial Against Janssen’s ZYTIGA®

NEW YORK, Sept. 19, 2016 /PRNewswire/ — Today, the U.S. Patent & Trademark Office (PTO) granted Argentum Pharmaceuticals LLC’s petition for inter partes review (IPR) against all claims of the sole unexpired patent listed as covering Janssen Oncology, Inc.’s ZYTIGA® (abiraterone acetate) drug in the Food & Drug Administration’s Orange Book that will remain after Janssen’s initial patent on the drug expires later this year.  Argentum challenges claims 1−20 of Janssen’s U.S. Patent No. 8,822,438, which the Orange Book states will expire in 2027.

The PTO concluded that Argentum has established a “reasonable likelihood that it will prevail with respect to its challenge to claims 1−20 of the ‘438 patent on the asserted grounds.”  The decision marks the beginning of an IPR trial that will be conducted by three specialist patent judges within the PTO’s Patent Trial & Appeal Board.  A final decision on patentability in the IPR is due within 1 year.

About Argentum Pharmaceuticals

Argentum is a generic drug company with core competencies in intellectual property and pharmaceutical operations. By working with branded and generic pharmaceutical companies and healthcare payors, Argentum intends to reduce the overall cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices. http://www.argentumpharmaceuticals.com

http://www.prnewswire.com/news-releases/argentum-pharmaceuticals-succeeds-in-starting-patent-cancellation-trial-against-janssens-zytiga-300330130.html

Argentum Pharmaceuticals and KVK Tech Succeed in Starting Patent Cancellation Trial Against Alcon’s PAZEO®

NEW YORK, Aug. 1, 2016 /PRNewswire/ — The U.S. Patent & Trademark Office (PTO) granted a petition for inter partes review (IPR) filed by Argentum Pharmaceuticals LLC and its manufacturing partner KVK Tech, against all challenged claims of the sole patent listed as covering Alcon’s PAZEO® (0.7% olopatadine hydrochloride ophthalmic solution) drug in the Food & Drug Administration’s Orange Book.  Argentum and KVK challenged claims 1-4, 8, 12, 13, 21 and 22 of Alcon’s U.S. Patent No. 8,791,154, and on July 18, 2016 the PTO concluded there is a “reasonable likelihood that [petitioner] would prevail in showing that the claims it challenges are unpatentable”.  The decision marks the beginning of an IPR trial that will be conducted by three specialist patent judges within the PTO’s Patent Trial & Appeal Board (PTAB).  A final decision on patentability in the IPR is due within 1 year.  The successful institution of this petition marks the first time the PTAB has instituted an IPR against this patent.

About Argentum Pharmaceuticals

Argentum is a generic drug company with core competencies in intellectual property and pharmaceutical operations. By working with branded and generic pharmaceutical companies and healthcare payors, Argentum intends to reduce the overall cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices. www.argentumpharmaceuticals.com

About KVK Tech

KVK is a recognized leader in the development and manufacture of high-quality, FDA-approved medicines, and possesses operational expertise in pharmaceutical manufacturing, packaging, sales, distribution, research & development, and customer service. KVK’s expertise runs the gamut and includes solid oral, powder, liquid, and proprietary dosage technologies.  KVK has expanded its capabilities into sterile products as well, with a 225,000 sq./ft., state-of-the-art sterile injectable facility being qualified later this year.  KVK takes pride in its ability to advance medical care and offer low-cost, high-quality alternatives in response to today’s healthcare challenges.  KVK is one of the few manufacturers of generic pharmaceuticals who handles all of its manufacturing, packaging, and distribution in the United States. www.kvktech.com

http://www.prnewswire.com/news-releases/argentum-pharmaceuticals-and-kvk-tech-succeed-in-starting-patent-cancellation-trial-against-alcons-pazeo-300307269.html

Argentum Pharmaceuticals Succeeds in Starting Patent Cancellation Trial Against UCB’s VIMPAT®

NEW YORK, May 23, 2016 /PRNewswire/ — Today, the U.S. Patent & Trademark Office (PTO) granted Argentum Pharmaceuticals LLC’s petition for inter partes review (IPR) against all claims of the sole remaining patent listed as covering UCB Inc.’s VIMPAT®(lacosamide) drug in the Food & Drug Administration’s Orange Book.  The PTO concluded that Argentum has established a “reasonable likelihood that it would prevail in showing that claims 1-13 of the ‘551 patent [U.S. Patent RE 38,551] are unpatentable.”  The decision marks the beginning of an IPR trial that will be conducted by three specialist patent judges within the PTO’s Patent Trial & Appeal Board.  A final decision on patentability in the IPR is due within 1 year.

In addition to Argentum’s instituted IPR, Argentum also filed an ex parte reexamination request against this same patent that raises additional grounds of unpatentability than those in the IPR.  A decision by the PTO on Argentum’s reexamination request is due no later than July 29, 2016.

Unlike today’s successful institution of Argentum’s IPR petition, a prior IPR petition filed by a group of generic companies against this same patent was denied in January 2015.  Those companies were Actavis, Inc., Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Amneal Pharmaceuticals, LLC, Amneal Pharmaceuticals of New York, LLC, Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., Breckenridge Pharmaceutical, Inc., Vennoot Pharmaceuticals, LLC, Sandoz Inc., Sun Pharma Global FZE, and Sun Pharmaceutical Industries, Ltd.

About Argentum Pharmaceuticals

Argentum is a generic drug company with core competencies in intellectual property and pharmaceutical operations. By working with branded and generic pharmaceutical companies and healthcare payors, Argentum intends to reduce the overall cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices. http://www.argentumpharmaceuticals.com

http://www.prnewswire.com/news-releases/argentum-pharmaceuticals-succeeds-in-starting-patent-cancellation-trial-against-ucbs-vimpat-300273542.html

KVK Tech And Argentum Pharmaceuticals Announce Partnership To Commercialize Pharmaceutical Products Made In The U.S.A.

NEW YORK, Feb. 1, 2016 /PRNewswire/ — Argentum has entered into a nonexclusive collaboration agreement with KVK Tech to launch and commercialize pharmaceutical products.  KVK is a recognized leader in the development and manufacture of high-quality, FDA-approved medicines, and possesses operational expertise in pharmaceutical manufacturing, packaging, sales, distribution, research & development, and customer service. KVK’s expertise runs the gamut and includes solid oral, powder, liquid, and proprietary dosage technologies.  KVK is in the process of expanding its capabilities into aseptic products as well with a 225,000 sq./ft. sterile injectable being qualified this year.  KVK takes pride in its ability to advance medical care and offer low-cost, high-quality alternatives in response to today’s healthcare challenges.  KVK is one of the few manufacturers of generic pharmaceuticals who handles all manufacturing, packaging, and distribution in the United States.

To learn more about KVK, please go to www.kvktech.com

MADE IN AMERICA

All KVK Tech products are made in the USA in strictest accordance with FDA, DEA, and DEP guidelines

About Argentum Pharmaceuticals
Argentum is a generic drug company with core competencies in intellectual property and pharmaceutical operations. By working with branded and generic pharmaceutical companies and healthcare payors, Argentum intends to reduce the overall cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices.

http://www.prnewswire.com/news-releases/kvk-tech-and-argentum-pharmaceuticals-announce-partnership-to-commercialize-pharmaceutical-products-made-in-the-usa-300213451.html