API and IP Newsletter

 

Contents

• ANDA approvals in November 2024
• General information
• US Supreme Court will not hear drug industry challenge to Arkansas contract pharmacy law
• Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications
• Intellectual Property
• Silimed Vs Polytech

ANDA approvals in November 2024

We follow ANDA approvals. There were 77 ANDA approvals in November 2024. There are 60 ANDA approvals and 17 tentative approvals. The leading companies are as follows:

Company	# ANDA	Company	# ANDA
Macleods Pharms LTD	6	Aspiro	2
Somerset Theraps LLLC	4	Dr Reddys	2
Aurobindo Pharma LTD	3	Gland Pharma LTD	2
Fresenius Kabi	3	Hikma	2
Lupin	3	Mylan Labs LTD	2
Alembic	2	Rubicon	2
Amneal Pharms	2	Steriscience	2

The comments about some of the ANDA approvals are below. 

Drug Name	Company	Comments
LANSOPRAZOLE.      ANDA  #208671	MACLEODS PHARMS LTD	This approval is for Delayed Release Pellets 15 MG and 30 MG. There are many other approvals. This approval is for a prescription.  Natco and Glenmark's approval for 15 MG is for OTC. However, this is not a tiny market, referring to the USD 150 million market 2-3 years ago. The recent US sales data is not available in the public domain.
DEFERASIROX             ANDA  #209426	TORRENT	This approval is for 150 MG, 200 MG and 500 MG Tablet For Suspension Oral. According to IQVIA sales data, three years ago, oral suspension -- 125 mg, 250 mg and 500 mg -- had annual sales of approximately USD 106 million. There are several other approvals. Deferasirox is an iron chelator (binder). It combines with iron in the blood.
TOPIRAMATE                ANDA  #215638	XIAMEN LP PHARM CO	This approval is for Capsule, Extended Release; Oral. Topiramate Extended-Release Capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older. Topiramate Extended-Release Capsules (RLD Trokendi® XR) had an annual sale of USD 253 million in the U.S.
OLMESARTAN MEDOXOMIL                  ANDA  #210682	CADILA PHARMS LTD	This approval is for 5, 20, and 40 MG tablets. Olmesartan Medoxomil had annual sales of USD 42 million in the United States a couple of years ago.  Olmesartan is used alone or together with other medicines to treat hypertension.
IVABRADINE HYDROCHLORIDE  ANDA  #215238	ALEMBIC	This approval is for 5 mg and 7.5 mg tablets. There are five other ANDA approvals.  Ivabradine tablets, 5 mg and 7.5 mg, had annual sales of $137 million in the US, according to IQVIA’s Moving Annual Total (MAT) data.  Zydus and few others were eligible for 180 days of shared generic exclusivity. After 180 days of first wave launches, the FDA started approving other ANDAs.  Ivabradine is used to reduce the risk of hospitalization for worsening heart failure.
DILTIAZEM HYDROCHLORIDE ANDA  #216968	ALEMBIC	This approval is for 120 MG, 180 MG, 240 MG, 300 MG and 360 MG Capsule, Extended Release; Oral.  According to IQVIA, the estimated market size for Diltiazem hydrochloride extended-release capsules for the 12 months ending June 2024 is $105 million. Diltiazem Hydrochloride capsules are used to treat hypertension.

General information

US Supreme Court will not hear drug industry challenge to Arkansas contract pharmacy law

The U.S. Supreme Court on Monday declined to hear an appeal by the nation's leading drug industry group challenging an Arkansas law requiring pharmaceutical companies to offer discounts on drugs dispensed by third-party pharmacies that contract with hospitals and clinics serving low-income populations.

News here

Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

News here

Intellectual Property 

Silimed Vs Polytech

The EU patent EP2581193 was issued to Polytech Health and Aesthetics GmbH. 

The patent concerns the process for manufacturing implants or intermediate products of such implants, particularly breast implants. It will be valid until 2031. The patent was granted in 2015 and was not opposed by anyone at the EPO during the permitted opposition period. 

Silimed is a Brazilian company that is the largest manufacturer of silicone gel implants in Latin America. It is present in several countries and is the sales leader in the Brazilian market. 

Silimed claimed to be the inventor of this technology and filed an entitlement action in 2017 in the Higher Regional Court of Frankfurt. 

The details about the German Civil Court system can be found here. 

Silimed submitted to the Higher Regional Court that Polytech was its distribution partner. 

Silimed argued that it provided Polytech with all the necessary information to seek a CE mark to distribute Silimed products in Europe. CE marking is a regulatory standard that indicates a product meets the safety, health, and environmental requirements set by the European Union (EU). 

To secure a CE mark, the approving authority must be provided with many technical documents. 

More details about the CE mark can be found in Wikipedia. Here

It is interesting to note that Silimed was unsuccessful at the first instance (i.e., the Higher Regional Court Frankfurt ) when it requested documents from Polytech that they had supplied for the product registration and to secure the CE mark. 

Silimed appealed. Then, the Federal Court of Justice reversed the decision of the Frankfurt court. The judges criticised the previous instance Court for not sufficiently examining  Silimed’s claims about the invention. 

The Judges addressed the question of defendant Polytech’s obligation to hand over documents.

Senate of the Higher Regional Court Frankfurt concluded that Silimed is the inventor of the technology. It ordered Polytech to assign patent rights of EP2581193 to Silimed. 

The German Court recognised the value of the Trade Secret. These days, I don’t come across many cases related to Trade Secrets, but this is one of the rare Trade Secret cases in Europe.  

More details about the case are Here