September 2026 505(b)(2) Approvals Breakdown, Vanda v. Teva Non-Infringement Victory, & Sanofi’s $8B Mega-Deal

Summary of the blog: 5-minute read

API & IP Intelligence Roundup (05 October 2026)

This edition evaluates the latest wave of 505(b)(2) NDA approvals addressing unmet clinical needs across multi-billion-dollar oncology, metabolic, and cardiovascular markets, landmark pharmaceutical deals, and a critical Delaware Federal Court ruling applying the Supreme Court’s Hikma precedent to insulate generic tasimelteon from late-stage continuation patent claims.

1. September 2026 505(b)(2) NDA Approvals & Tentative Approvals

The FDA granted final and tentative approvals to five differentiated 505(b)(2) formulations that bypass reference-product administration hurdles or innovator patent thickets:

OMCAZIO (Cabozantinib Laurylsulfate, NDA #220613 – Handa Oncology LLC): Final Approval for oral capsules (11.5 mg, 23 mg, 34.5 mg) referencing Cabometyx (~$1.4B US sales). Formulated as a novel laurylsulfate salt with enhanced oral bioavailability that can be taken with or without food, eliminating Cabometyx’s strict fasting mandate. Handa's non-infringing salt strategy bypasses Exelixis's malate patents (which enjoin standard generic ANDAs until 2030), clearing immediate commercial entry supported by its WO2024163400A1 patent family.
BEXLUTRY (Lutetium Lu 177 Dotatate, NDA #218525 – Curium US LLC): Final Approval for an injectable radiopharmaceutical IV infusion (10 mCi/mL) referencing Lutathera (~$450M–$500M+ US sales). The approval follows a June 2026 Delaware federal court decision declaring Novartis's asserted patent claims invalid and not infringed, providing an independent domestic radiopharmaceutical manufacturing source to ease ongoing isotope supply shortages.
EMPAGLIFLOZIN (NDA #220758 – Ridhisidhi Therapeutics): Tentative Approval for an Oral Solution referencing Jardiance (>$4.5B US sales). Eliminates pill-swallowing barriers for >30% of heart failure and CKD patients suffering from dysphagia. Unexpired Boehringer Ingelheim compound, use, and crystalline patents (asserted in D. Del. Case 1:26-cv-00372) and pediatric exclusivity hold final commercialisation until 2028–2029.
ZUEINO (Diclofenac Sodium, NDA #218379 – Adventa Pharma LLC): Final Approval for a 37.5 mg parenteral injection solution. Provides rapid-onset, opioid-sparing analgesia for acute post-operative and inpatient pain, avoiding toxic solvent excipients (e.g., propylene glycol, benzyl alcohol) common in older parenteral diclofenac products. Cleared with no blocking patent stays.
APIXABAN (NDA #220446 – Lupin Inc.): Tentative Approval for an Oral Suspension (1.25 mg/mL) referencing Eliquis (>$10B US sales). Provides accurate, uniform oral liquid delivery for stroke and elderly patients with feeding tubes or dysphagia without the hazards of crushing tablets. Commercial launch from Lupin's Somerset, NJ facility awaits innovator patent expiry in late 2026–2028.

2. Key Commercial & Corporate Developments

Sanofi & Regeneron Expand Alliance in $8B Deal: The partners resolved ongoing legal disputes and expanded their collaboration, with Sanofi committing $1 billion upfront and up to $7 billion in development milestones to reinforce its post-Dupixent pipeline.
United Therapeutics Wins Treprostinil Patent Ruling Against Liquidia: The U.S. District Court for the District of Delaware found Liquidia Technologies infringes two claims of United Therapeutics' patent covering inhaled treprostinil for pulmonary hypertension associated with interstitial lung disease (PH-ILD).

3. IP Landmark: Delaware Court Grants Summary Judgment in Vanda v. Teva (Hetlioz®)

In Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. & Apotex (D. Del., Sept. 24, 2026), Judge Jennifer L. Hall granted summary judgment of non-infringement across all counts, protecting generic tasimelteon capsules:

Context: Following the invalidation of Vanda's initial patent estate in Tasimelteon I, generic filers launched at-risk (Teva in Dec 2022, Apotex in Jan 2024). Vanda sued on continuation patents (US 11,285,129 and US 11,918,556) claiming methods of dosing tasimelteon conditioned on discontinuing beta-blockers.
Induced Infringement & Hikma Precedent: Applying the Supreme Court’s Hikma v. Amarin (2026) framework, the court held that Section 7.3 of the generic label stating that nighttime beta-blocker administration "may reduce the efficacy of tasimelteon" is an informational warning, not an affirmative instruction or recommendation to discontinue beta-blocker therapy.
Contributory & Direct Infringement: Direct infringement under § 271(a) was conceded; contributory infringement under § 271(c) failed because extensive medical records confirmed substantial non-infringing co-prescribing in clinical practice.
Generic Implication: Solidifies the legal principle that branded innovators cannot weaponise neutral pharmacodynamic labelling warnings to establish induced infringement against launched generic competitors.

#PharmaIP #505b2 #FDA #GenericDrugs #PatentLitigation #HatchWaxman #Tasimelteon #Cabozantinib #Eliquis #Jardiance #SidvimBlog

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I encourage you to read the detailed blog below.

Recent 505 (b) (2) filings

General information

Sanofi, Regeneron expand tie-up with $8 billion drug-development deal, settle legal dispute
United Therapeutics Corporation Prevails in Patent Litigation Against Liquidia

Intellectual Property

Tasimelteon 20 mg capsules: Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc

Recent 505 (b) (2) filings

We follow 505 (b) (2) filings.

Generally, 505(b)(2) NDAs relate to changes compared to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). More details 505 (b) (2) FDA approvals can be found here.

The details of 505(b)(2) filings for September 2026 are as follows:

General information

Sanofi, Regeneron expand tie-up with $8 billion drug-development deal, settle legal dispute

Sanofi to pay $1 billion upfront and up to $7 billion in milestones
Sanofi CEO Garijo says clearer roles and accountability will underpin the revamped collaboration
Further deals still needed to bolster Sanofi's post-Dupixent pipeline, analysts say

News here

United Therapeutics Corporation Prevails in Patent Litigation Against Liquidia

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the United States District Court for the District of Delaware issued an opinion that finds Liquidia Technologies, Inc. (Liquidia) infringes two claims of United Therapeutics’ patent covering the use of inhaled treprostinil to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).

News here

Intellectual Property

Tasimelteon 20 mg capsules: Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc

Case Overview & Procedural History

On 24 September 2026, U.S. District Judge Jennifer L. Hall of the U.S. District Court for the District of Delaware granted summary judgment of non-infringement to generic defendants Teva Pharmaceuticals USA, Inc. and Apotex Inc./Apotex Corp. in consolidated Hatch-Waxman patent litigation brought by Vanda Pharmaceuticals Inc.

The litigation represents the second wave of patent enforcement regarding Hetlioz (tasimelteon 20 mg capsules), indicated for Non-24-Hour Sleep-Wake Disorder ("Non-24"), an orphan circadian rhythm illness common in blind individuals. In the earlier Tasimelteon I litigation, Chief Judge Connolly held all asserted method-of-treatment claims invalid as obvious, a judgment affirmed by the Federal Circuit in May 2023. Following that appellate ruling, the FDA granted final approval to Defendants' ANDAs, prompting Teva to commercially launch generic tasimelteon capsules in December 2022 and Apotex to launch in January 2024.

Vanda subsequently initiated second-wave litigation in Delaware, asserting two late-issuing continuation patents sharing the same specification: U.S. Patent Nos. 11,285,129 (the "'129 patent", issued March 2022) and 11,918,556 (the "'556 patent", issued March 2024). Defendants moved for summary judgment of non-infringement

Asserted Patents & Accused Labelling

The Asserted Patents claim methods that condition tasimelteon dosing on whether a patient is receiving treatment with a beta-adrenergic receptor antagonist (beta-blocker):

'129 Patent (Claim 1): Directs determining whether a patient takes a beta-blocker; if not, administering 20 mg tasimelteon before bedtime; if yes, instructing the patient to cease the beta-blocker and then administering tasimelteon.
'556 Patent (Claim 1): Recites treating a sleep disorder in a patient on a beta-blocker by discontinuing the beta-blocker and administering tasimelteon to avoid decreased efficacy.

The generic labels are substantively identical to Hetlioz’s FDA-approved labelling:

Sections 1 and 2.2 specify 20 mg taken orally at bedtime.
Section 7.3 notes: "Beta-adrenergic receptor antagonists have been shown to reduce the production of melatonin... Nighttime administration of beta-adrenergic receptor antagonists may reduce the efficacy of tasimelteon."

Unlike other interaction subsections instructing prescribers to "avoid use," Section 7.3 contains no instruction or recommendation to discontinue or avoid beta-blockers.

The Court’s Legal Analysis & Holdings

In the U.S. Patent Act, patent infringement is defined across several distinct statutory categories:

35 U.S.C. § 271(a) (Direct Infringement): Prohibits anyone without authorisation from making, using, offering to sell, or selling a patented invention within the United States, or importing it into the United States during the patent term.
35 U.S.C. § 271(b) (Induced Infringement): Establishes liability for anyone who actively takes affirmative steps to aid, encourage, or instruct another party to commit direct patent infringement with knowledge of the patent.
35 U.S.C. § 271(c) (Contributory Infringement): Prohibits offering to sell, selling, or importing a component or material constituting a material part of a patented invention knowing it is specially adapted for infringement and lacks a substantial non-infringing use.
35 U.S.C. § 271(e)(2) (Artificial Hatch-Waxman Infringement): Creates an artificial act of infringement when an applicant submits an ANDA or 505(b)(2) NDA to the FDA seeking commercial approval to market a patented drug before the relevant patent expires.

In the present case, the court viewed it as follows.

1. Direct Infringement (35 U.S.C. § 271(a))

Because Defendants sell pharmaceutical capsules rather than practice medical treatment steps on patients, and Vanda conceded at oral argument that it was not alleging direct infringement, the court granted summary judgment of non-infringement under § 271(a).

2. Induced Infringement (35 U.S.C. § 271(b)) & Impact of Hikma

Applying the Supreme Court’s landmark ruling in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (2026), the court evaluated whether Defendants took active steps to encourage direct infringement:

Under Hikma, active inducement requires affirmative conduct to bring about infringement, not merely informational statements that could theoretically be inferred to encourage it.
Judge Hall held that no reasonable juror could find that Section 7.3’s statement, warning that nighttime beta-blocker administration "may reduce efficacy" constitutes an active recommendation or affirmative step to instruct discontinuation.

3. Contributory Infringement (35 U.S.C. § 271(c))

Vanda conceded no contributory infringement regarding the '556 patent. For the '129 patent, Vanda argued generic tasimelteon lacked substantial non-infringing uses because all routine clinical practice infringes (physicians check medications and would take patients off beta-blockers).

Under Federal Circuit precedent (Vita-Mix Corp.), non-infringing uses are substantial when they are not unusual, impractical, or aberrant.
The factual record showed numerous real-world patients co-administered tasimelteon and beta-blockers (e.g., administering beta-blockers in the morning). Vanda’s expert admitted he did not know whether clinicians actually practised all claimed steps, and therefore could not prove that non-infringing co-administration was unusual or aberrant.

4. Artificial Infringement (35 U.S.C. § 271(e)(2)(A))

The court noted § 271(e)(2)(A) was inapplicable because Defendants' products had been commercially launched years earlier. Because no underlying infringement existed as a matter of law, the court entered summary judgment of non-infringement.

Strategic & Industry Implications

Affirmative Guidance Post-Hikma: Innovators cannot rely on neutral pharmacodynamic warnings in product labels to establish induced infringement; the label must affirmatively direct or encourage the patented step.
Insulating Generic Commercial Launches: The ruling completely protects Teva and Apotex from patent liability, preventing brand sponsors from using continuation patents with negative dosing limitations to disrupt generic commercial markets.

Details here

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