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Wednesday, May 01, 2024 7:34:38 AM
On April 1, 2021, United Therapeutics Corp. and Supernus Pharmaceuticals, Inc. (“UTC/Supernus”) filed a complaint in the United States District Court for the District of Delaware against ANI Pharmaceuticals, Inc., asserting that ANI’s proposed Treprostinil extended release drug product, which is subject to ANI’s Abbreviated New Drug Application No. 215667, infringes U.S. Patent Nos. 7,417,070, 7,544,713, 8,252,839, 8,349,892, 8,410,169, 8,747,897, 9,050,311, 9,278,901, 9,393,203, 9,422,223, 9,593,066 and 9,604,901 (“the Asserted Patents”). The complaint seeks injunctive relief, attorneys' fee and costs. ANI filed its answer and counterclaims on May 28, 2021, denying UTC/Supernus’ allegations and seeking declaratory judgment that ANI has not infringed any valid and enforceable claim of the Asserted Patents, that the Asserted Patents are invalid, and an award of attorneys’ fees and costs. On May 26, 2022, the parties’ respective claims and
counterclaims were dismissed pursuant to a confidential settlement agreement.
According to United Therapeutics 2024 Q1 filing.
In May 2022, we settled litigation with ANI Pharmaceuticals, Inc. (ANI) regarding its ANDA seeking FDA approval to market a generic version of Orenitram. Under the settlement agreement, ANI can market its generic version of Orenitram in the United States beginning in December 2027, although it may be permitted to enter the market earlier under certain circumstances. Competition from these generic companies could reduce our net product sales and profits.
In Q1 2024 United therapeutics reported $106.2 million in sales.
Recent ANIP News
- ANI Pharmaceuticals Announces the FDA Approval and Launch of Naproxen Delayed-Release Tablets, USP • GlobeNewswire Inc. • 07/02/2024 11:00:00 AM
- ANI Pharmaceuticals’ CEO Nikhil Lalwani Named EY Entrepreneur Of The Year® 2024 New Jersey Award Winner • GlobeNewswire Inc. • 06/25/2024 11:00:02 AM
- ANI Pharmaceuticals to Further Expand Rare Disease Business through Acquisition of Alimera Sciences • GlobeNewswire Inc. • 06/24/2024 10:50:44 AM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/18/2024 08:37:33 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/17/2024 09:05:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:23:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/11/2024 08:51:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/06/2024 10:21:47 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/06/2024 11:34:13 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 11:59:24 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 10:08:03 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/04/2024 08:35:27 PM
- ANI Pharmaceuticals to Present at the 2024 Jefferies Global Healthcare Conference • GlobeNewswire Inc. • 05/29/2024 08:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/24/2024 12:03:53 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/24/2024 12:02:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/23/2024 11:58:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/23/2024 11:54:13 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/23/2024 11:45:47 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/23/2024 08:06:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 10:14:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2024 09:21:53 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/20/2024 08:57:32 PM
- ANI Pharmaceuticals Announces the Launch of Kionex® Suspension • GlobeNewswire Inc. • 05/20/2024 10:50:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:01 PM
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NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM