Page 146 - CW E-Magazine (29-7-2025)

Pharmaceuticals Pharmaceuticals

COURT FIGHT ENSURING AFFORDABILITY
Novartis fails to block MSN from selling generic Government revises prices of 71 medicines

heart drug in US The government has revised the revised prices for 25 anti-diabetes for-
prices of 71 important drug formu- mulations that contain sitagliptin. It
A US federal judge rejected Swiss Entresto was Novartis’ top-selling lations, including those used to treat also mentions several antidiabetic com-
drugmaker Novartis’ request for a product in 2024, with sales of $4.05-bn metastatic breast cancer, diabetes, binations containing empaglifl ozin.
preliminary injunction to stop MSN in the US and $7.82-bn worldwide. peptic ulcers, and severe infections.
Pharmaceuticals from selling a generic In February, the NPPA had issued
version of the blockbuster heart MSN proposed selling generic tab- The National Pharmaceutical Pric- an order asking drug manufacturers
medication, Entresto. MSN is a unit of lets marked with an “M,” and slightly ing Authority (NPPA) announced the to share the updated price lists with
India-based MSN Group. smaller than and similar in colour to new prices through a notifi cation. As dealers, state drug controllers, and the
Entresto. per the notifi cation, manufacturers may government. This was aimed at ensur-
US District Judge Evelyn Padin add Goods and Services Tax (GST) ing transparency in drug pricing. “The
said Novartis did not show that MSN In a 34-page decision, Judge Padin only if they have paid or are liable to order to display the price list is to allow
would cause irreparable harm, adding that MSN’s tablets looked too similar said she erred in previously ruling that pay it on the retail price. citizens to cross-check whether the
that “the availability of a generic alter- to Entresto and would confuse consumers. the similarities resulted in so-called pharmacies are selling at the price fi xed
native to a life-saving medication is in MSN proposed selling tablets under “trade dress” infringement. She said The NPPA notifi cation also includes by NPPA or not,” said an offi cial.
the public interest.” the name Novadoz, which blends the generic drugs regularly mimic their
names of Novartis and its Sandoz drug branded counterparts, and Novartis has Aurobindo to produce, supply long acting HIV treatment drug
The judge also reversed her prior unit. US patent exclusivity for Entresto not shown that MSN mimicked Entresto
ruling that Novartis would likely prove expires on July 16, the judge said. to confuse people. Hyderabad-based Aurobindo Pharma ViiV Healthcare, majority owned
said it will manufacture and supply the by GSK, with Pfi zer and Shionogi as
Pharma sector accounts for a big chunk of PLI long-acting injectable HIV treatment shareholders, and the MPP, have an-
cabotegravir across 133 countries.
nounced an update to their voluntary
disbursements in FY25 The company has been selected as licensing agreement to include patents
relating to its use in a long-acting
one of the generic manufacturers un- regimen. This update now includes
Large-scale electronics manufac- In 2024-25, the government has dis- der the expanded voluntary licensing long-acting cabotegravir (CAB LA) for
turing and pharmaceuticals cornered bursed a total of Rs. 10,114-crore. PLI agreement between the Medicines HIV treatment, in addition to its earlier
about 70 percent of the total fi scal fi rms in the electronics sector received Patent Pool (MPP) and ViiV Healthcare, use for prevention only. The treatment
incentive disbursements in 2024-25 Rs. 5,732-crore, while pharmaceutical the company said in a statement. The injectable HIV treatment across 133 offers an alternative to daily pills,
under the production-linked incentive drugs received Rs. 2,328-crore, the data agreement allows Aurobindo to manu- countries, including several low and allowing patients to receive just one
(PLI) schemes, according to govern- showed. facture and supply the long-acting middle-income markets, it added. injection every one or two months.
ment data.
In 2023-24, the disbursals stood at Dr. Reddy’s gets seven observations from USFDA
The scheme was introduced in 2021 Rs. 9,721-crore. The fi gures highlight
to support domestic manufacturing the country’s growing strength in these for Andhra plant
across 14 sectors with an outlay of segments amid efforts to boost manu-
Rs. 1.97 lakh-crore. facturing and value-added exports. Dr. Reddy’s Laboratories has recei- “We have been issued a Form 483 with
ved a Form 483 with seven observa- seven observations, which we will
Godavari Biorefi neries gets Chinese patent for anti-cancer tions from the US health regulator for its address within the stipulated timeline,”
Srikakulam-based plant in Andhra it added.
molecule Pradesh, according to a regulatory fi ling.
As per the USFDA, Form 483 is
Godavari Biorefi neries, through its for its novel anti-cancer molecule – cancer stem cells in in-vitro studies. The US Food and Drug Adminis- issued to a fi rm’s management at the
clinical-stage biotech division Sathgen Hydroxy-1,4-naphthalenedione. These compounds have demonstra- tration (USFDA) conducted the GMP conclusion of an inspection when the
Therapeutics, has been granted a ted signifi cant effi cacy against multi- and a Pre-Approval Inspection (PAI) at investigator has observed any condi-
patent by the China National Intel- “This patent covers a novel class ple cancer cell types, including breast the formulations manufacturing facility tions that may constitute violations of
lectual Property Administration (CNIPA), of compounds that have exhibited and prostate cancer,” the company from July 10 to 18, 2025, the Hydera- the Food, Drug and Cosmetic (FD&C)
China’s patent and trademark offi ce, strong inhibitory effects on cancer and said. bad-based drug major said in the fi ling. Act and related Acts.

146 Chemical Weekly July 29, 2025 Chemical Weekly July 29, 2025 147

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