August 2026 Generic Approvals Breakdown: Blockbuster Clearances for Pomalidomide, Cabozantinib, and Nintedanib

Summary of this blog- 5-minute read

API & IP Intelligence Roundup (14 September 2026)

This edition covers the USFDA's August 2026 ANDA approval surge, global respiratory and emergency health updates, and a critical Federal Circuit patent precedent defining the enforceability of crystalline genus claims in Exelixis v. MSN.

1. USFDA ANDA Trends: Indian Generic Dominance & Multi-Product Openings

The FDA recorded 54 ANDA regulatory decisions in August 2026 (43 final approvals, 11 tentative approvals). Indian manufacturers demonstrated commanding leadership by capturing 33 of the 54 total decisions (61.1%), led by multi-product approvals for Aurobindo, Zydus Lifesciences, Dr. Reddy's Laboratories, and Macleods:

Oncology Wave: A coordinated cluster of final approvals on August 31 for Pomalidomide capsules across Cipla, Dr. Reddy’s, Sun Pharma (SPIL), and Sandoz cleared long-standing Paragraph IV settlements referencing Pomalyst® (~$3.5B peak global sales).
Speciality & Cardiology Approvals: Indian developers secured key approvals in high-barrier categories, including Sacubitril/Valsartan (Umedica), Nintedanib Esylate (Macleods and Biocon), and Pitolisant HCl (Lupin and MSN).
The Cabozantinib Paradox: MSN secured final ANDA approval for Cabozantinib (S)-Malate on August 14, 2026, just two weeks before an adverse appellate patent ruling blocked commercial marketing.

2. Global Regulatory & Clinical Updates

Hikma Advances Epinephrine Nasal Spray: Regulatory submissions for needle-free emergency treatment of anaphylaxis have been accepted for review across the US, Europe, the UK, and Canada.
Biological Anti-Aging Findings: Insilico Medicine's pulmonary candidate, rentosertib, demonstrated unexpected secondary outcomes in clinical studies, showing blood protein shifts linked to slower biological ageing.

3. IP Benchmark: Exelixis v. MSN Upholds Cabometyx Exclusivity Through 2030

In Exelixis, Inc. v. MSN Laboratories (Fed. Cir. Aug. 31, 2026), the Federal Circuit addressed polymorph design-arounds and genus written description under 35 U.S.C. § 112(a):

Crystalline Genus Claims Upheld: The Federal Circuit held Exelixis's asserted "Malate Salt Patents" (US 11,091,439; 11,091,440; and 11,098,015) valid and infringed. The Court ruled that disclosing a chemical formula, structure, and crystalline state satisfies written description for a defined, purely structural crystalline genus without requiring characterisation of every polymorph.
The 2030 Injunction Anchor: Because the Malate Salt Patents carry terminal disclaimers tied to parent patent US 8,877,776, their enforceable life terminates on October 8, 2030. Even though MSN successfully developed a proprietary Form S polymorph and holds final FDA ANDA approval, it is legally barred from commercial launch until 2030.

This could delay MSN's launch until 2030. It will be interesting to see MSN's strategy for cabozantinib after this decision.

#PharmaIP #USFDA #GenericDrugs #HatchWaxman #Cabometyx #Pomalidomide #PatentLaw #IndianPharma #RegulatoryAffairs #SidvimBlog

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I encourage you to read the detailed blog below.

Content

ANDA approvals-August 2026

General information

Hikma advances epinephrine nasal spray with multi-market regulatory filings
Drug developed for lung disease may slow biological ageing in surprising ‘bonus’

Intellectual Property

Exelixis, Inc. v. MSN Laboratories Private Ltd

ANDA approvals-August 2026

USFDA ANDA Approvals in August 2026:

USFDA issued 54 ANDA approvals: 43 final approvals and 11 tentative approvals. Indian generic manufacturers demonstrated commanding leadership by capturing 33 of the 54 total approvals, led by multi-product approvals for Aurobindo, Zydus Lifesciences, Dr. Reddy's Laboratories, and Macleods.

On August 31, the FDA triggered a major commercial opening in haematology-oncology by granting simultaneous final approvals for Pomalidomide capsules to multiple generic players (Cipla, Dr Reddy's, Sun Pharma/SPIL, and Sandoz). Concurrently, Indian developers secured clearances for high-barrier oral kinase inhibitors and heart failure blockbusters, including Cabozantinib S-Malate (MSN), Sacubitril/Valsartan (Umedica), Nintedanib Esylate (Macleods and Biocon), and Pitolisant HCl (Lupin and MSN). The table below summarises approvals.

Top Generic Approvals for Indian Developers: Molecule Profiles

General information

Hikma advances epinephrine nasal spray with multi-market regulatory filings

Hikma shared that regulatory submissions for its epinephrine nasal spray, being developed for the emergency treatment of allergic reactions (anaphylaxis), have been accepted for review by regulators in the United States, Europe and the UK.

The company has also filed a submission for its epinephrine nasal spray in Canada, with plans to expand filings beyond these markets in due course.

News here

Drug developed for lung disease may slow biological aging in surprising ‘bonus’

A drug being developed to treat a serious lung disease may also help to slow the aging process, researchers say.

In a small clinical study, patients who took rentosertib – developed by Insilico Medicine in Massachusetts – showed changes in blood proteins that made them appear biologically younger.

News here

Intellectual Property

Exelixis, Inc. v. MSN Laboratories Private Ltd

Case Background

On 31 August 2026, the U.S. Court of Appeals for the Federal Circuit decided Exelixis, Inc. v. MSN Laboratories Private Ltd. The case arose from Hatch-Waxman patent infringement litigation in the District of Delaware regarding Cabometyx (cabozantinib (L)-malate tablets), an oral multi-kinase inhibitor approved to treat renal cell carcinoma, hepatocellular carcinoma, and thyroid cancer.

OB listed patents for cabozantinib tablets Cabometyx

In August 2019, MSN filed ANDA No. 213878 seeking FDA approval for generic cabozantinib (L)-malate tablets. MSN sought to design around Exelixis's patents by developing a proprietary crystalline polymorph, designated Form S, and obtained its own patent. Exelixis responded by asserting two sets of Orange Book-listed patents:

The Malate Salt Patents (U.S. Patent Nos. 11,091,439; 11,091,440; and 11,098,015): Expiring in 2030, these patents broadly claim crystalline cabozantinib (L)-malate salts, formulations, and oncology treatment methods. MSN conceded infringement but challenged validity for lack of adequate written description under 35 U.S.C. § 112(a). For example, the verbatim claim of US 11,091,439 is 1. N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl) cyclopropane-1,1-dicarboxamide (Cabozantinib), malate salt, wherein said salt is crystalline.
The '349 Patent (U.S. Patent No. 11,298,349): Claims pharmaceutical compositions "essentially free" (200 ppm or less) of a genotoxic 6,7-dimethoxy-quinoline-4-ol ("1-1") impurity. MSN contested both infringement and validity, alleging inherent obviousness over prior art.

Following a bench trial, the district court held that the asserted claims of the Malate Salt Patents had sufficient written description and were not invalid. For the '349 patent, the court found no infringement by MSN and held that MSN failed to prove invalidity. Exelixis subsequently dropped its cross-appeal on non-infringement of the '349 patent. The decision discussed the '349 patent extensively, but I will cover it in another write-up.

The Federal Circuit’s Decision

Circuit Judges affirmed the validity of the Malate Salt Patents while dismissing and vacating the '349 patent ruling:

Affirmed: The district court's determination that the asserted claims of the Malate Salt Patents satisfy the written description requirement of 35 U.S.C. § 112(a).
Dismissed & Vacated: Dismissed MSN's validity appeal concerning the '349 patent as moot and vacated the underlying non-obviousness judgment under Munsingwear.

Legal Analysis

Written Description Support for Crystalline Genus Claims (35 U.S.C. § 112(a))

MSN argued that because the patent specification only described two specific polymorphs (Form N-1 and Form N-2), it lacked written description to possess the broader genus of all "crystalline cabozantinib (L)-malate" salts. MSN asserted that other polymorphs (up to 14 forms, including Form S) could have unpredictable densities, solubilities, and melting points, relying on AbbVie.

The Federal Circuit affirmed the district court's findings:

Common Structural Features (Ariad & GSK): Under Ariad, a genus is adequately described by disclosing a representative number of species or common structural features. Citing GSK v. Banner Pharmacaps, the court held that disclosing the full chemical formula, chemical structure, crystalline state, and synthetic processes adequately identifies the genus’s shared structural features.
Purely Structural Claims: The claims require no functional or therapeutic performance property. The chemical identity is identical across all polymorphs. Unclaimed physicochemical differences between polymorphs do not render the genus description deficient.
Distinction from AbbVie: Unlike AbbVie, which involved an expansive antibody genus with divergent structures, the crystalline malate genus is chemically uniform and narrow (capped at 14 polymorphs).

Strategic & Commercial Implications

This decision fortifies Exelixis’s market exclusivity for Cabometyx through 2030, perhaps blocking generic market entry despite MSN's attempt to design around innovator polymorph patents using Form S. The ruling confirms that structural crystalline genus claims can be sustained without individual characterisation of every possible polymorph. This can be complicated, so let us break it down in simple bullet points.

The Patents Asserted in the Lawsuit: The patents Exelixis asserted and litigated before the District Court and the CAFC are the "Malate Salt Patents", namely U.S. Patent Nos. 11,091,439; 11,091,440; and 11,098,015. MSN conceded infringement of these three patents, and the CAFC affirmed their validity.
The Role of the '776 Patent (U.S. Patent No. 8,877,776): During patent prosecution, Exelixis filed terminal disclaimers on the '439, '440, and '015 patents over its earlier-issued parent patent, the '776 patent (which specifically claimed crystalline polymorph Form N-2). A terminal disclaimer ties the legal expiration date of later patents to an earlier patent to prevent double patenting.
Why the Injunction Runs to 2030? Under standard statutory patent term rules, patents filed in the late 2010s/2020s would nominally run well past 2035. However, because of the terminal disclaimers, the enforceable statutory life of the asserted '439, '440, and '015 patents is truncated to end on the exact day the '776 patent expires in 2030.

The '439, '440, and '015 patents were litigated, held valid, and found infringed, while the '776 patent serves as the legal anchor, setting their expiration date and thus the injunction's duration to 2030. MSN has already secured final FDA approval, and it would be interesting to follow MSN’s strategy based on this decision, which was handed down 15 days after MSN’s FDA approval.

Decision here

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