Indian Pharma Captures 57% of USFDA ANDAs, Medicare Pricing Lawsuit, & Delhi HC Precedent in ZARA v. ZORA

 Summary of the blog post- 5-minute read. 

1. Indian Pharma Leads September 2026 USFDA ANDA Approvals. The USFDA granted 56 ANDA approvals (49 final, 7 tentative) in September 2026, with Indian generic manufacturers capturing 32 approvals (over 57% of the total). Indian developers demonstrated strong technical capability across complex solid oral oncology, cardiovascular therapies, and CNS indications:

• Sacubitril and Valsartan Tablets (Aurobindo): Targets Novartis's blockbuster heart failure franchise Entresto ($4.5B US peak sales). Launch timing remains tied to resolution of secondary polymorph and combination patent litigation, alongside multi-filer generic competition from Torrent, Lupin, and MSN.

• Pomalidomide Capsules (MSN): Final approval referencing Celgene/BMS’s Pomalyst ($2.2B US peak sales) for relapsed/refractory multiple myeloma, governed by confidential settlement agreements establishing staggered, volume-limited entry.

• Ibrutinib Capsules (Hetero Labs): Approved against AbbVie’s Imbruvica ($3.2B US peak sales), where litigation spanning extensive patent thickets and IRA Medicare price negotiations structure generic entries toward the late 2020s.

• Lumateperone Tosylate Capsules (Zydus): Tentative approval referencing Intra-Cellular Therapies’ Caplyta ($1.5B–$2B+ US sales), positioning Zydus among an early Paragraph IV challenger group awaiting patent expiration in the 2030s.

• Dasatinib Tablets (MSN): Final approval referencing BMS's Sprycel ($1.2B US peak sales), adding a key player to the competitive second-generation BCR-ABL kinase inhibitor segment under negotiated launch windows.

2. Key Commercial & Policy Developments

• Pharma Lobby Challenges Medicare Price Indexing: Top pharmaceutical industry groups sued the Trump administration over its newly finalised "GLOBE" rule, arguing that using a "most-favoured-nation" mechanism to benchmark Medicare Part B hospital drug prices against lower international rates constitutes unlawful executive overreach.

• Emergence of OTC Biopharmaceuticals: Philadelphia-based Medicinal Technologies closed private financing to advance MEnera™, a nanocarrier-based bioengineered product for women's reproductive health, through the 505(b)(2) NDA pathway to pioneer an over-the-counter biopharmaceutical regulatory category.

3. IP Landmark: Delhi High Court Protects ZARA from Dilution by ZORA In Industria De Diseno Textil, S.A. v. Registrar Of Trade Marks, the Delhi High Court cancelled the registration of the mark ZORA (Class 24):

• Section 11(2) Scope: Brand owners do not require a formal court declaration or official Registry listing to invoke Section 11(2) protection; proving established factual brand equity under Section 11(6) is sufficient.

• Anti-Dissection Rule: The Registrar erred in dissecting four-letter marks into separate syllables ("ZA" vs. "ZO"). Both marks share the consonant frame Z-R-A and ending cadence, making a single-vowel shift deceptively similar when viewed as an indivisible whole.

• Dilution Over Confusion: Section 11(2) protects famous marks against dilution by blurring and unfair advantage across allied or wholesale trade channels, even without proof of actual consumer confusion.

#USFDA #ANDA #IndianPharma #GenericDrugs #Entresto #Pomalidomide #Imbruvica #Caplyta #Trademarks #ZaraVZora #SidvimBlog

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I encourage you to read the entire blog post. 

Contents

ANDA approvals-September 2026

General information

Pharma lobby sues Trump administration over Medicare drug price cuts

Greater Philadelphia’s Medicinal Technologies Creates a New “Over-the-Counter Biopharmaceutical” Category

Intellectual Property

Zara vs Zora- Industria De Diseno Textil, S.A. v. Registrar Of Trade Marks & Anr.

ANDA approvals-September 2026

USFDA ANDA Approvals in September 2026: 

In September 2026, the USFDA issued 56 ANDA approvals: 49 final and 7 tentative. Indian generic manufacturers demonstrated commanding leadership by capturing 33 of the 56 total ANDA approvals, led by multi-product approvals for Zydus Lifesciences, Aurobindo Pharma, MSN Laboratories, Lupin, and Macleods Pharmaceuticals. 

During the month, Indian developers secured notable clearances across high-barrier oral oncology, cardiovascular therapies, and speciality formulations. Key approvals included final nods for Pomalidomide capsules and Dasatinib tablets (MSN Laboratories), Ibrutinib capsules/tablets (Hetero Labs), Sacubitril and Valsartan tablets (Aurobindo Pharma), and Crisaborole topical ointment (Macleods Pharmaceuticals), alongside a tentative approval for Lumateperone Tosylate capsules (Zydus). The table below summarises approvals.

Top  Generic Approvals for Indian Developers: Molecule Profiles

General information

Pharma lobby sues Trump administration over Medicare drug price cuts

The pharmaceutical industry's top lobby group on Wednesday sued to invalidate the Trump administration's efforts to benchmark US drug prices to lower costs overseas in the Medicare health insurance program, arguing that it is an illegal government overreach.

The GLOBE rule intends to set hospital drug prices for Medicare patients. Its final version was published last week on exactly how a "most-favored-nation" pricing system based on what is paid in a group of comparable countries would be integrated in the Medicare Part B program.

News here

Greater Philadelphia’s Medicinal Technologies Creates a New “Over-the-Counter Biopharmaceutical” Category 

Medicinal Technologies, a biotech research and development company founded in 2018 and operating in the Philadelphia region since 2022, has created a new category of medicine: over-the-counter biopharmaceuticals.  Led by Dr. Sheryene Tejeda, the company’s founder, CEO, and lead medical scientist, Medicinal Technologies aims to fill the space between unregulated supplements and synthetic pharmaceuticals. Backed by a six-figure private investment closed this year, the company is now consolidating its headquarters in Greater Philadelphia.

MEnera™ is Medicinal Technologies’ flagship over-the-counter biopharmaceutical, addressing women’s reproductive health, including infertility caused by hormonal imbalance, and amenorrhea. Built on a proprietary nanocarrier formulation and bioengineering covered by U.S. patent applications, MEnera is advancing toward FDA review through the 505(b)(2) New Drug Application pathway.

News here

Intellectual Property 

Zara vs Zora- Industria De Diseno Textil, S.A. v. Registrar Of Trade Marks & Anr.

Let us read an interesting trademark case: Zara vs Zora.

On July 6, 2026, the Delhi High Court (Justice Jyoti Singh) allowed an appeal filed by Industria De Diseno Textil, S.A. (Inditex, owner of ZARA) under Section 91 of the Trade Marks Act, 1999. The court quashed the Registrar of Trade Marks' order dated February 8, 2024, which had dismissed Inditex's opposition and registered the mark ZORA (No. 4310686 in Class 24) in favour of Respondent No. 2 (Aggarwal Bag House). 

Directing the cancellation and removal of the ZORA registration from the Register of Trade Marks, the court clarified three major tenets of Indian trademark jurisprudence: the threshold for well-known protection under Section 11(2), the anti-dissection principle for short word marks, and the distinction between consumer confusion and brand dilution. 

Background and Procedural History

Inditex conceived and adopted the mark ZARA in Spain in 1975, expanding into India through contract manufacturing since 1986–87, securing Indian registrations in Class 25 (1993) and Class 24 (2003), and opening flagship physical retail stores via its joint venture with the Tata Group (Inditex Trent) since 2010. 

The Delhi High Court had previously recognised ZARA as a well-known mark under Section 2(1)(zg) in Industria De Diseno Textil S.A. v. Oriental Cuisines Pvt. Ltd. (2015). 

In October 2019, Respondent No. 2 applied for ZORA in Class 24 (claiming user since June 2016 for plain, coated, and waterproof fabrics used as bag linings). Inditex opposed the application, but the Registrar rejected the opposition on grounds that "ZA" and "ZO" were phonetically and visually dissimilar prefixes, that the goods catered to different consumers (wholesale fabric rolls vs. retail fashion/home products), and that no evidence of actual consumer confusion was shown. Inditex appealed. 

Key Legal Issues & Judicial Determinations

1. Well-Known Protection Under Section 11(2) Does Not Require a Formal Prior Declaration

The respondent argued that Inditex could not invoke Section 11(2) against allegedly dissimilar goods because ZARA was not formally included on the Registrar's published list of well-known marks. 

Justice Jyoti Singh rejected this contention, establishing that Section 11(2) conditions protection on whether the mark "is a well-known trade mark in India," not whether it is a "declared" well-known mark. 

Reading Section 11(2) alongside Explanation (b) to Section 11 and Section 2(1)(zg), the court held that an opponent need only establish through cogent evidence (duration of use, advertising, turnover, and market recognition under Section 11(6)) that it is entitled to protection as a well-known mark. 

2. Rejection of Syllable Dissection: The Anti-Dissection Rule

The court held that the Registrar committed a fundamental legal error by dissecting the four-letter marks into prefixes ("ZA" vs. "ZO") and suffixes ("RA"). Citing landmark rulings including Corn Products Refining Co. (1959), Amritdhara Pharmacy (1962), and South India Beverages (2014), the court reiterated that competing word marks must be judged by their overall impression on an ordinary consumer with average intelligence and imperfect recollection: 

• Visual & Structural Identity: Both marks consist of four capital letters sharing an identical consonant frame (Z-R-A). Substituting a single middle vowel ("A" with "O") does not create a meaningful structural difference. 
• Phonetic Cadence: Both marks end in the identical "RA" cadence. Relying on precedents like Essco Sanitations (ESSCO vs. OSSO) and Ajanta Pharma (OLOPAT vs. OLPET), minor vowel substitutions are easily slurred or mispronounced in everyday Indian speech. 

3. Section 11(2) vs. Section 11(1): Confusion vs. Dilution by Blurring

The Registrar erred in dismissing the opposition for lack of "actual consumer confusion". Justice Singh clarified that while Section 11(1) requires a likelihood of consumer confusion across similar goods, Section 11(2) shifts the inquiry to unfair advantage and dilution of distinctiveness (dilution by blurring) across dissimilar or allied goods. 

Even though Respondent No. 2 claimed to sell only bag-lining fabric from Sadar Bazar, the court noted that wholesale fabric rolls prominently displaying "ZORA" penetrate identical intermediate trade channels (textile dealers, tailors, bag manufacturers) where ZARA maintains significant goodwill. Furthermore, Respondent No. 2's annual turnover surged from ~₹2.45 crore in 2016–17 to over ₹31.34 crore in 2023, evidencing bad-faith riding on ZARA’s reputation. 

Strategic & Industry Takeaways

• Unfettered Cross-Class Protection: Brand owners can successfully oppose confusingly similar marks under Section 11(2) by proving factual brand equity and reputation before the Registrar without needing a pre-existing formal court decree or Rule 124 listing. 
• Vowel-Shift Imitations Barred: Attempting to evade well-known word marks by altering a single vowel (e.g., ZARA to ZORA) violates the anti-dissection rule and fails the test of overall commercial impression. 
• Purity of the Register Upheld: The Delhi High Court directed the Registrar to rectify the register and cancel the ZORA registration within two months.

Decision here