Latest news with #AbbreviatedNewDrugApplication
Yahoo
09-06-2025
- Business
- Yahoo
U.S. Court of Appeals for the Federal Circuit Affirms Prior Delaware District Court Rulings in Favor of Acadia in NUPLAZID® (pimavanserin) Composition of Matter Patent
- Composition of matter patent affirmed, provides protection into 2030 - Builds on recent ruling in favor of Acadia for formulation patent expiring in 2038 SAN DIEGO, June 09, 2025--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Court of Appeals for the Federal Circuit affirmed a decision issued by the U.S. District Court for the District of Delaware in December 2023 confirming validity of the NUPLAZID® (pimavanserin) '740 composition of matter patent. The affirmance came in Acadia's litigation against MSN Laboratories Pvt. Ltd. and MSN Pharmaceuticals, Inc. In its affirmance, the Appeals Court applied the precedent established in Allergan USA, Inc. v. MSN Laboratories Private Ltd., MSN Pharmaceuticals, Inc., Sun Pharmaceutical Industries Limited, holding that "a first filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date." "We are gratified that the U.S. Federal Appeals Court has affirmed the lower court's ruling in favor of our composition of matter patent for NUPLAZID, securing protection into 2030 for this patent, and beyond based on the recent favorable ruling for our formulation patent providing patent protection for NUPLAZID 34 mg capsule formulation into 2038," said Catherine Owen Adams, Chief Executive Officer. "These decisions reinforce our commitment to safeguarding the intellectual property that underpins our innovations in addressing serious, unmet medical needs." This follows the U.S. District Court for the District of Delaware ruling in favor of Acadia regarding its '721 formulation patent for NUPLAZID which ruled in favor of Acadia on both infringement and validity arguments in its formulation patent litigation against Aurobindo Pharma Limited and other ANDA (Abbreviated New Drug Application) filers. About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis and multiple other programs targeting neuroscience and neuro-rare diseases. For more information, visit us at and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "potential," "continue" and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) the impact of the court ruling on our business and our ability to defend ourselves in the future; (ii) the continued patent protection for NUPLAZID; and (iii) the anticipated timing for termination of such protections. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our ability to maintain, protect and enhance our intellectual property; the outcome of other existing and potential future lawsuits challenging our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our annual report on Form 10-Q for the quarter ended March 31, 2025 as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law. View source version on Contacts Investor Contacts: Acadia Pharmaceuticals Kildani(858) 261-2872ir@ Acadia Pharmaceuticals Tieszen(858) 261-2950ir@ Media Contact: Acadia Pharmaceuticals Kazenelson(818) 395-3043media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
09-06-2025
- Business
- Business Wire
U.S. Court of Appeals for the Federal Circuit Affirms Prior Delaware District Court Rulings in Favor of Acadia in NUPLAZID ® (pimavanserin) Composition of Matter Patent
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Court of Appeals for the Federal Circuit affirmed a decision issued by the U.S. District Court for the District of Delaware in December 2023 confirming validity of the NUPLAZID ® (pimavanserin) '740 composition of matter patent. The affirmance came in Acadia's litigation against MSN Laboratories Pvt. Ltd. and MSN Pharmaceuticals, Inc. In its affirmance, the Appeals Court applied the precedent established in Allergan USA, Inc. v. MSN Laboratories Private Ltd., MSN Pharmaceuticals, Inc., Sun Pharmaceutical Industries Limited, holding that 'a first filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.' 'We are gratified that the U.S. Federal Appeals Court has affirmed the lower court's ruling in favor of our composition of matter patent for NUPLAZID, securing protection into 2030 for this patent, and beyond based on the recent favorable ruling for our formulation patent providing patent protection for NUPLAZID 34 mg capsule formulation into 2038,' said Catherine Owen Adams, Chief Executive Officer. 'These decisions reinforce our commitment to safeguarding the intellectual property that underpins our innovations in addressing serious, unmet medical needs.' This follows the U.S. District Court for the District of Delaware ruling in favor of Acadia regarding its '721 formulation patent for NUPLAZID which ruled in favor of Acadia on both infringement and validity arguments in its formulation patent litigation against Aurobindo Pharma Limited and other ANDA (Abbreviated New Drug Application) filers. About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis and multiple other programs targeting neuroscience and neuro-rare diseases. For more information, visit us at and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as 'may,' 'will,' 'should,' 'could,' 'would,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'estimates,' 'projects,' 'predicts,' 'potential,' 'continue' and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) the impact of the court ruling on our business and our ability to defend ourselves in the future; (ii) the continued patent protection for NUPLAZID; and (iii) the anticipated timing for termination of such protections. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our ability to maintain, protect and enhance our intellectual property; the outcome of other existing and potential future lawsuits challenging our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our annual report on Form 10-Q for the quarter ended March 31, 2025 as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.
Business Upturn
07-06-2025
- Business
- Business Upturn
Lupin gets U.S. FDA tentative approval for Generic Oxcarbazepine ER Tablets
Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg strengths. These tablets are the generic equivalent of Oxtellar XR® ER Tablets by Supernus Pharmaceuticals and are indicated for the treatment of partial-onset seizures in patients aged 6 years and above. Lupin's version of the drug will be manufactured at its Nagpur facility in India. According to IQVIA MAT April 2025 data, Oxcarbazepine ER Tablets (RLD Oxtellar XR®) recorded estimated annual sales of USD 206 million in the United States, underscoring the potential market opportunity for Lupin. Headquartered in Mumbai, Lupin is a leading global pharmaceutical company with a strong footprint in the U.S. and India. The company focuses on a broad range of therapy areas including central nervous system disorders, respiratory, cardiovascular, anti-infective, and women's health. It operates 15 manufacturing sites and 7 research centers globally, supported by over 23,000 employees. Lupin continues to expand its U.S. portfolio of complex generics and remains committed to delivering high-quality, affordable medicines that improve health outcomes for patients around the world. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Yahoo
06-06-2025
- Business
- Yahoo
Harmony Biosciences settles generic drug litigation, strengthens patent
Harmony Biosciences (HRMY) announced a settlement agreement with Lupin Limited, resolving patent infringement litigation related to Lupin's Abbreviated New Drug Application for a generic version of WAKIX. Under the agreement, Lupin will receive a license to launch its generic product no earlier than January 2030 (or July 2030 with pediatric exclusivity), or earlier under certain circumstances. Harmony asserted multiple patents covering WAKIX, its FDA-approved treatment for excessive daytime sleepiness or cataplexy in adults and pediatric patients with narcolepsy. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on HRMY: Disclaimer & DisclosureReport an Issue Harmony Biosciences Settles Patent Dispute with Lupin Harmony Biosciences assumed with an Outperform at Oppenheimer Harmony Biosciences Holds 2025 Annual Stockholders Meeting Harmony Biosciences price target raised to $48 from $44 at Mizuho Harmony Biosciences Holdings: Strong Market Position and Growth Potential Justify Buy Rating Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Business Standard
04-06-2025
- Business
- Business Standard
Gland Pharma share rises 2% in trade on Wednesday, June 4; here's why
Gland Pharma share price: Pharmaceutical company Gland Pharma shares increased as much as 1.58 per cent to hit an intraday high of 1,619 per share on Wednesday, June 4, 2025. At 11:10 AM, Gland Pharma shares continued to trade near day's high, up 1.33 per cent at 1615 per share. Why did Gland Pharma share price rise? Gland Pharma shares rose after it secured United States Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection 2.5 mg/mL. 'Gland Pharma Limited (Gland or Company), a generic injectable & ophthalmicfocused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Angiotensin II Acetate Injection 2.5 mg/mL,' Gland Pharma said, in a press release. Angiotensin II is a vasoconstrictor indicated for increasing blood pressure in adults with septic or other distributive shock. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Giapreza of La Jolla Pharma LLC, the company revealed. 'Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity,' the company claimed. The product had US sales of approximately $58 million for the twelve months ending March 2025, according to IQVIA. Gland Pharma Q4 results Gland Pharma reported a 3 per cent year-on-year (YoY) decline in its consolidated net profit to ₹186.5 crore for the fourth quarter ended March 2025 (Q4FY25), compared to ₹192.4 crore in the same period last year. Revenue from operations fell 7 per cent YoY to ₹1,424.9 crore from ₹1,537.5 crore. The company's Ebitda stood at ₹347.5 crore, marginally down from ₹358.7 crore a year ago. However, the Ebitda margin improved to 24 per cent in Q4FY25, compared to 23 per cent in the corresponding quarter last year. Research and development (R&D) expenses during the quarter were ₹50.3 crore, accounting for 4.9 per cent of revenue. For the full financial year FY25, R&D expenses stood at ₹192.2 crore, or 4.7 per cent of annual revenue. Gland Pharma dividend About Gland Pharma Founded in 1978 in Hyderabad, Gland Pharma has evolved from a contract manufacturer of small-volume liquid parenterals to one of the largest injectable-focused pharmaceutical companies globally. Operating predominantly under a B2B model, it has a presence in over 60 countries, including the US, Europe, Canada, Australia, and India. The company's portfolio spans a wide range of sterile injectables such as vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, as well as oncology and ophthalmic products. Notably, it pioneered Heparin technology in India.
