DeclutterPharma

The Center for Strategic and International Studies (CSIS) is an American think tank based in Washington, D.C. I follow their website, and yesterday there was a good article by Dr. Anne McDonald Pritchett , titled 'How Most-Favored Nation Policy Could Undermine U.S. Leadership.' Dr. Anne McDonald Pritchett, PhD, is the founder of Pritchett Policy Associates, LLC, which offers expertise in life sciences, policy, advocacy, and strategic communications to address public policy challenges. She is a leading expert on the biopharmaceutical manufacturing supply chain and on various public policies affecting biomedical innovation, including intellectual property, cybersecurity, STEM, and economic and regulatory guidelines. The article raises concerns about the potential negative effects of the May 2025 Executive Order (EO), which aims to reduce prescription drug prices in the United States by benchmarking them against prices in other developed countries. The author contends that this ...

There is recent news that the FDA has unveiled a plan to shorten review times for new drugs to one or two months. This means pharmaceutical companies may be able to monetise their inventions early. The doctors may be able to obtain new medications for patients with life-threatening diseases and severe conditions more quickly than they currently do. Announcement CNPV The USFDA announced its Commissioner’s National Priority Voucher (CNPV) program to benefit Americans’ health. Drug developers can use the new voucher to join a special FDA priority program that shortens review time from about 10-12 months to 1-2 months after a sponsor’s final drug application submission. However, physicians will need to consider the safety of these rapidly approved drugs and their potential costs to patients. Under the new program, the FDA aims to approve certain medications within one to two months through the agency’s accelerated approval program. Draft Guideline The USFDA issued a draft guidance fo...

Gland Pharma announced that the issuance of an EIR for their Vishakhapatnam facility by the US FDA indicates that the agency has found the facility to be in an acceptable state of compliance with its Current Good Manufacturing Practice (cGMP) regulations.  An Establishment Inspection Report (EIR) from the US FDA is a document issued to a company after inspecting its facility, indicating that the inspection has been closed. EIRs are of three types: No Action Indicated (NAI), Voluntary Action Indicated (VAI), and Official Action Indicated (OAI). EIR from the USFDA for Gland Pharma's Visakhapatnam facility shows a "Voluntary Action Indicated" (VAI) status. This indicates that the USFDA has accepted the company's response to inspection observations and considers the issues resolved through voluntary corrective actions.  The facility at Vishakhapatnam supplies sterile APIs for FDF manufacturers and its own ANDAs at Gland Pharma. This inspection closure will ensure the cont...

Kindeva has already approved the Fentanyl patch. It was approved in November 2016.  This news is about an abuse-resistant Fentanyl patch.  The patches often contain a large surplus of the therapeutic agent to ensure that a therapeutically effective dose is delivered to the patient over the intended period. As a result, used patches can hold a significant amount of drug even after the prescribed use. Additionally, many of these drugs are highly potent and susceptible to intentional abuse or accidental misuse, which can lead to severe adverse reactions if ingested by children or animals. Nutriband Inc., in collaboration with Kindeva, has reached a major milestone with the successful completion of commercial manufacturing and scale-up for its AVERSA Fentanyl, an abuse-deterrent transdermal patch. According to analysts, a new $15 price target for Nutriband underscores the company's progress toward starting clinical supplies production and submitting an Investigational New Drug (...

US Medical Reimbursment System The medical reimbursement system in the United States is very complex. I am not aware of any such system existing at the national level in India, so I cannot draw any parallels. In India, health insurance is primarily for hospitalisations, and, based on my information (which is mainly based on my health insurance), other reimbursements are generally not covered. However, I could be wrong. In the United States, there is HCPCS. Healthcare Common Procedure Coding System (HCPCS).  HCPCS is a standardised coding system used mainly for billing and processing health insurance claims, especially for Medicare and Medicaid.  The Centers for Medicare & Medicaid Services (CMS) maintains it. HCPCS is divided into two levels: Level I, which uses Current Procedural Terminology (CPT) codes, and Level II, which provides codes for products, supplies, and services not included in CPT.  You will notice that in the United States, almost everything is covered...

The FDA has granted interchangeability designation to HADLIMA ™  (adalimumab-bwwd; Samsung Bioepis, Organon), a biosimilar to Humira (adalimumab; AbbVie), as a high- and low-concentration autoinjector and a high-concentration prefilled syringe. HADLIMA (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of Humira (adalimumab). The interchangeability designation for HADLIMA is based on a Pharmacokinetics, Efficacy, Safety, and Immunogenicity study of SB5 versus Humira in patients with moderate to severe chronic plaque psoriasis. What is interchangeability? According to the FDA An interchangeable biosimilar is a biosimilar that meets the additional requirements outlined by the law, allowing the FDA to approve both biosimilar and interchangeable biosimilar medications. An interchangeable biosimilar product may be substituted for the original produc...

Alembic Pharmaceuticals has announced that it has received the Establishment Inspection Report (EIR) from the USFDA for its API-III manufacturing facility located in Karakhadi, Gujarat. The USFDA inspection was conducted from 17 March 2025 to 21 March 2025. Alembic had so far active 141 DMFs. There is a high likelihood that approximately 41 DMFs listed below could have been manufactured at the Karakhadi site. API business could account for about 20% of Alembic's overall business, and therefore, the Karakhadi site would make a significant contribution to Alembic’s presence in the United States.

Harmony Biosciences holds the marketing authorisation for pitolisant (WAKIX). WAKIX was designed and developed by Bioprojet in France. Harmony holds an exclusive license from Bioprojet to develop, manufacture, and commercialise pitolisant in the United States. Pitolisant is used to treat excessive daytime sleepiness caused by narcolepsy. It received approval in the U.S. in August 2019. Seven ANDA filers filed on the NCE-1 date in August 2023. Orange Book listed patents Harmony Biosciences Holdings, Inc., announced a settlement agreement with Lupin on June 5, 2025, resolving the patent infringement litigation related to Lupin’s ANDA for a generic version of WAKIX (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will be dismissed. The court trial is to start in February 2026. Lupin will receive a license to launch its generic product no earlier than January 2030 (or July 2030 with pediatric exclusi...

The FDA/CDER SBIA Chronicles, the newsletter of the CDER Small Business and Industry Assistance team, provides useful information to assist the industry in all aspects of drug marketing and regulation. The newsletter issues are archived at http://www.fda.gov/cdersmallbusinesschronicles. The last publication was on 19 May 2025. It outlines the critical aspects of patents and exclusivity relevant to drug development and approval. It emphasises the importance of understanding these concepts for both innovator drug sponsors and generic manufacturers. Patents: A patent is a property right granted by the USPTO, allowing inventors to exclude others from making, using, or selling their invention, typically for 20 years from the filing date. Patent information is essential during the drug application process. Submission: Applicants must submit patent information with original NDAs and supplements using FDA Form 3542a before approval. Post-approval, updates are submitted via FDA Form 3542 for p...

There are three 505(b)(2) NDAs approved by the USFDA and one NDA that received tentative approval from the USFDA in May 2025. The details are as follows. More details can also be found in the API and IP newsletter published by us. 

Natco Pharma announced the conclusion of the US FDA inspection at its Mekaguda, Hyderabad, Active Pharmaceutical Ingredients (API) Unit. The USFDA inspected the API manufacturing plant from June 9 to June 13, 2025.  Upon conclusion of the inspection, the Company received one observation in Form 483. The company is confident in addressing the point raised by the USFDA in Form 483. According to its website, the facility currently has a capacity of around 400 KL, and approximately 700 staff members work there. Along with the USFDA, the facility has also been approved by the Australian TGA, the German Health Authority Hamburg, the Korean Health Authority, the PMDA in Japan, and Cofepris in Mexico. It is possible that the names listed below are some of the important DMFs being manufactured at the site.

Rein Therapeutics was advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Their lead molecule is peptide LTI-03. The company has secured two U.S. patents, US 12,280,088 and US 12,280,089, for the dry powder peptide formulation of LTI-03, a drug candidate being developed for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.  These patents, titled "Dry Powder Formulation of Caveolin-1 Peptides and Methods of Use Thereof”.  These inventions generally relate to molecular biology, pharmaceutics, and medicine. More particularly, they are concerned with compositions and methods for delivering dry powder therapeutic polypeptide compositions to subjects, such as through delivery to the respiratory system. The company claims these patents enhance its intellectual property and support the ongoing development of LTI-03 as a potential first-in-class therapeutic option. Two clinic...

Unicycive Therapeutics announced that the U.S. FDA has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), which is used to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. The US FDA is reviewing the NDA with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. This indicates that the FDA is evaluating the application, and a decision on whether to approve OLC is anticipated around that time. Unicycive Therapeutics claims in their press release that OLC is protected by a strong global patent portfolio, which includes an issued patent on the composition of matter that provides exclusivity until 2031 and the potential for a patent term extension until 2035 following OLC approval.  Oxylanthanum carbonate is undergoing FDA approval through the 505(b)(2) regulatory pathway. This pathway allows the manufacturer to reference data from a previously approved drug, Fosrenol (lanthanum carbonate), for certain aspects ...

Lupin announced that it has received tentative approval from the USFDA for its abbreviated new drug application (ANDA) for Oxcarbazepine extended-release (ER) tablets. Oxcarbazepine ER Tablets in 150 mg, 300 mg, and 600 mg dosages are bioequivalent to Oxtellar XR® ER Tablets, also available in 150 mg, 300 mg, and 600 mg, from Supernus Pharmaceuticals, Inc., and are indicated for the treatment of partial-onset seizures. This product will be manufactured at Lupin’s Nagpur facility in India. Oxcarbazepine ER tablets (RLD Oxtellar XR) had estimated annual sales of $206 million in the U.S. (IQVIA MAT April 2025). The Lupin Press Release can be found here . Apotex Corp. is the first generic manufacturer to launch oxcarbazepine ER tablets in the United States; Apotex made this launch in September 2024. There are four other tentative approvals for oxcarbazepine ER tablets, and several patents listed in the Orange Book.  Supernus Pharmaceuticals and Apotex Corp. settled a patent infringemen...

Arvinas, Inc. announced the submission of a New Drug Application (NDA) to the USFDA with its partner Pfizer Inc., for vepdegestrant for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.  This submission is based on results from VERITAC-2 (NCT05654623), a global, randomised Phase 3 trial evaluating vepdegestrant versus fulvestrant. Certain bifunctional compounds can target specific cellular proteins for degradation via the ubiquitin-proteasome system. Examples of such proteolysis-targeting chimeric compounds (i.e., “PROTAC® protein degraders”) that target the Estrogen Receptor (ER) for ubiquitination and subsequent degradation are disclosed in patent family WO 2018102725 filed by Arvinas.  Patent family WO2024049922 A1 (Arvinas) describes Vepdegestrant for use in treating cancer. Patent family WO2025038481 A1 rela...

This write-up summarises the decision of the United States Court of Appeals for the Federal Circuit (CAFC) regarding a patent infringement case between Jazz Pharmaceuticals, Inc. (Jazz) and Avadel CNS Pharmaceuticals, LLC (Avadel). (06 May 2025) The dispute centered around Avadel's attempts to gain FDA approval and market its drug, Lumryz, for the treatment of idiopathic hypersomnia (IH), a condition characterised by excessive daytime sleepiness.  Jazz, the manufacturer of Xyrem® and Xywav® (sodium oxybate products used for narcolepsy and IH), sought to prevent Avadel from entering the IH market, claiming Avadel's actions infringed its patent rights. The case originated in the U.S. District Court for the District of Delaware, where Jazz obtained a permanent injunction preventing Avadel from pursuing FDA approval and marketing Lumryz for IH.  Avadel appealed, arguing the injunction was overly broad and infringed on activities protected by the Hatch-Waxman Act’s safe harbou...