USFDA ANDA Approvals March 2026: Key Generic Launches and Market Trends and Novo Nordisk vs. Dr. Reddy’s Semaglutide Ruling

Pharmaceutical Insights: March 2026 ANDA Approvals & IP Litigation Trends

Stay updated with the latest developments in the global pharmaceutical industry. From the USFDA's March 2026 ANDA approvals to landmark Intellectual Property (IP) disputes involving Novo Nordisk and AstraZeneca, this newsletter covers critical regulatory milestones and market shifts

USFDA ANDA Approvals – March 2026 In March 2026, the USFDA issued a total of 86 Abbreviated New Drug Application (ANDA) approvals, including 25 tentative approvals. A tentative approval signifies that while the generic drug meets all safety and quality standards, final marketing is delayed due to existing patents or exclusivities held by the brand-name manufacturer. Top Companies by ANDA Approvals Several leading pharmaceutical firms secured multiple approvals during this period. The companies sought more than 2 ANDA approvals in March 2026 are as follows. Aurobindo Pharma Ltd Dr. Reddy’s Laboratories Glenmark Pharmaceuticals Micro Labs Alkem Laboratories Zydus Lifesciences Key Generic Drug Highlights Moxifloxacin HCl (Macleods Pharms): A generic version of Bayer’s Avelox, this antibiotic targets a U.S. market estimated at $35–$45 million annually. Fluticasone Propionate (Glenmark): The first generic version of GSK’s Flovent HFA to receive a Competitive Generic Therapy (CGT) designation, granting Glenmark 180 days of exclusivity. Brimonidine Tartrate (Gland Pharma): A tentative approval for a generic version of Bausch + Lomb’s Lumify. Following a patent settlement in late 2025, Gland Pharma is positioned to enter the high-volume OTC redness-relief market. Emtricitabine, Rilpivirine, and Tenofovir (Laurus): A generic version of Gilead’s HIV-1 treatment, Complera, targeting a substantial $400 million market. Intellectual Property & Legal Updates Novo Nordisk vs. Dr. Reddy’s: The Semaglutide Dispute On March 9, 2026, the Delhi High Court dismissed Novo Nordisk’s appeal for an injunction against Dr. Reddy’s Laboratories regarding the anti-diabetic drug Semaglutide. The Conflict: Novo Nordisk alleged infringement of Indian Patent 262697. The Ruling: The court found the patent vulnerable to a "credible challenge" on the grounds of obviousness, noting that transitioning from the prior Genus Patent to Semaglutide was an evident step for a "person in the know." Market Impact: This ruling allows Dr. Reddy’s to continue importing and exporting Semaglutide. In response to generic competition, Novo Nordisk India reduced prices for Ozempic and Wegovy by 36% to 48% as of April 1, 2026. Semaglutide Pricing Comparison (Approx. Monthly Cost in INR) Natco Pharma: ₹1,290 – ₹1,750 Glenmark: ₹1,300 – ₹1,760 Zydus (Semaglyn): ₹2,200 Dr. Reddy’s: ₹4,200 Sun Pharma: ₹2,960 – ₹7,400 AstraZeneca and Sun Pharma Settle Patent Suits AstraZeneca and Sun Pharmaceutical Industries have agreed to dismiss three patent infringement lawsuits concerning proposed generic versions of the diabetes treatments Farxiga, Qtern, and Xigduo XR. The lawsuits centered on a patent covering the compound dapagliflozin, which expired in early April 2026. New Product Launches ANI Pharmaceuticals announced the FDA approval and launch of Isosorbide Mononitrate Tablets (10 mg and 20 mg). This product is the generic equivalent of the reference listed drug Monoket, used for treating heart-related chest pain. ----------------------XX------------------------------XX------------------------

Contents

ANDA approvals-March 2026

General information

AstraZeneca, Sun Dismiss Patent Suits Over Three Diabetes Drugs

ANI Pharmaceuticals Announces FDA Approval and Launch of Isosorbide Mononitrate Tablet

Intellectual Property

Novo Nordisk A/S Vs. Dr Reddy’s Laboratories Limited

ANDA approvals-March 2026

We follow ANDA approvals. In March 2026, the USFDA issued 86 ANDA approvals, of which 25 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug. The companies that could seek more than two ANDA approvals (including tentative ones) in February were as follows.
Some of our other comments about a few ANDA approvals sought by Indian companies are listed below.


General information

AstraZeneca, Sun Dismiss Patent Suits Over Three Diabetes Drugs

AstraZeneca Plc and Sun Pharmaceutical Industries Ltd. agreed to end three lawsuits alleging Sun’s proposed copies of AstraZeneca’s Farxiga, Qtern, and Xigduo XR diabetes treatments infringe a patent that expired last week. Both sides agreed to dismiss all claims and defenses in each lawsuit, though they left the door open for renewing allegations, according to the three orders Judge Richard G. Andrews issued Wednesday in the US District Court for the District of Delaware. Each of the complaints AstraZeneca filed in December 2023 alleged the targeted generic drug infringed US Patent No. 6,515,117, which covers the compound dapagliflozin. News here

ANI Pharmaceuticals Announces FDA Approval and Launch of Isosorbide Mononitrate Tablet

ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Isosorbide Mononitrate Tablet USP, 10 mg and 20 mg. ANI’s Isosorbide Mononitrate Tablet USP is the generic version of the reference listed drug (RLD) Monoket News here

Intellectual Property

Novo Nordisk A/S Vs. Dr Reddy’s Laboratories Limited

This judgment, delivered by the Delhi High Court on 09 March 2026, concerns an appeal by Novo Nordisk against a Single Judge's decision denying an interlocutory injunction in a patent infringement case. The dispute revolves around Semaglutide, an anti-diabetic drug patented by the appellant under Indian Patent 262697 (IN’697). Background and Initial Dispute In 2025, Novo Nordisk filed a suit alleging that Dr Reddy’s Laboratories Limited was infringing its patent by importing Semaglutide. While the respondents admitted to importing the drug, they contested the validity of the suit patent under Section 64(1) of the Patents Act, 1970, arguing it was vulnerable to revocation. On 02 December 2025, a Single Judge rejected Novo Nordisk's application for an interim injunction, finding that the respondents had raised a credible challenge to the patent’s validity. Prefatory Observations on Judicial Urgency Before addressing the legal merits, the Division Bench expressed significant concern about the timing of the appeal. The suit patent (IN’697) was scheduled to expire on 20 March 2026, just two months after the appeal was reserved for judgment. The Court questioned the irreparable loss claimed by the appellant, noting that after the expiry date, the patent would be open to global exploitation. The Bench highlighted the strain on the judicial system, noting that hours were spent arguing over matters of little importance, while cases involving the poor and needy remained pending. Despite these reservations, the Court proceeded to render a judgment as it was duty-bound to do so after hearing the arguments. Legal Standard: The Wander Confines The Court emphasised that its role was not a fresh examination of the merits but a review based on the principles established in Wander Ltd v. Antox (India) Pvt Ltd. According to this standard, an appellate court should not interfere with the lower court's discretion unless it was exercised arbitrarily, perversely, or in disregard of settled legal principles. Analysis of Patent Vulnerability The core of the legal analysis involved whether the respondents successfully established a credible challenge to the patent under Section 64(1).
  1. Section 64(1)(a): Anticipation by Prior Claiming. The Single Judge initially found the patent vulnerable under this section. However, the Division Bench disagreed. It clarified that Section 64(1)(a) requires a strict "claim-to-claim" comparison and identity between the suit patent and a prior patent. Since Semaglutide was not explicitly claimed in the prior Genus Patent (IN 275964, IN’964), the Bench held that this specific ground for revocation was not technically met.
  2. Section 64(1)(e) and (f): Novelty and Obviousness
The Bench agreed with the Single Judge that the patent was credibly challenged on the ground of obviousness.
  • The Difference: The only structural distinction between the Ala Semaglutide compound in the prior Genus Patent (IN’964) and the suit patent's Semaglutide was the replacement of Alanine (Ala) with alpha-aminoisobutyric acid (Aib) at the eighth position.
  • Teachings of Prior Art: The Court noted that the Genus Patent (IN’964) explicitly identified Aib as a preferred amino acid for substitution at that specific position.
  • The "Person in the Know" Test: Following the precedent in AstraZeneca AB v. Intas Pharmaceuticals, the Court applied the "person in the know" test because five of the inventors were common to both patents. From this perspective, transitioning from the Genus Patent to Semaglutide was considered an obvious step.
Conclusion The High Court concluded that although the Single Judge slightly conflated the concepts of "prior claiming" and obviousness, the final decision to deny the injunction was correct. Since a credible challenge under any clause of Section 64(1) is sufficient to defend against an infringement suit, the appeal was dismissed. The Court emphasised that its observations were only preliminary and would not affect the final decision on the case's merits. Business impact. The dismissal of the appeal allows Dr Reddy’s Laboratories (DRL) to continue importing and exporting Semaglutide, significantly weakening Novo Nordisk’s market exclusivity in India. For Novo Nordisk, the primary business impact is the loss of an interlocutory injunction restraining competitors just before its patent expires on 20 March 2026. In response to these generic entries, Novo Nordisk India slashed its own prices for Ozempic and Wegovy by 36% to 48% effective 01 April 2026.
Decision here



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