API and IP Newsletter

 

Contents

  • Very brief analysis of Exports of Cadila.

  • General information

  • Change in Data Exclusivity for Pharmaceutical Products in the United Arab Emirates

  • Nigerian drug regulator blacklists Gujarat pharma company for ‘substandard’ antibiotics

  • Intellectual Property


Very brief analysis of Exports of Cadila.

Last few weeks we are following Cadila Healthcare. We analysed their patent portfolio. We studied their import data; we reported about their probable development pipeline. Today we are analysing exports of  Cadila and arrived at some very interesting finding.

To start with, few graphs about commercial information about exports

Top oversees customers of Cadila

Top export countries by volume


Top 25 Exports of Cadila:

1.      Nebivolol and Amlodipine are among top exports.

2.      Most of top 10 exports is to trader in Ireland.

3.      US is top export by Value but far less in volume.

 

SIDVIM view: The main objective of this Newsletter is technical information and analysis of the data to derive technical insights. Here are few key observations.


Product Name

QTY

Unit

Foreign Company

Country

SAROGLITAZAR

1

Vls

COVANCE SOLUTIONS MADE REAL COVANCE

United States

SAROGLITAZAR

0.2

Gms

COVANCE LABORATORIES INC

United States

SAROGLITAZAR

0.2

Gms

COVANCE SOLUTIONS MADE REAL CO

United States

HALOBETASOL PROPIONATE LOTION 0.01%

10

Nos

NOVUM PHARMACEUTICAL RESEARCH

United States

SAROGLITAZAR

1

Vls

COVANCE SOLUTIONS MADE REAL

United States

TRAMADOL HYDROCHLORIDE.

0.12

Kg.

FUJIKAWA AND CO LTD

Japan

DONEPEZIL HYDROCHLORIDE

24

kg.

KOKANDO PHARMACEUTICALS CO LTD

Japan

TRAMADOL HYDROCHLORIDE.

0.12

Kg.

FUJIKAWA AND CO LTD

Japan

TRAMADOL HYDROCHLORIDE

0.18

Kg.

FUJIKAWA AND CO LTD

Japan

DONEPEZIL HYDROCHLORIDE

6.6

Kg.

KOKANDO PHARMACEUTICALS CO LTD

Japan

GLIBENCLAMIDE

11

Kg.

KADERA YAKUHIN LTD

Japan

TRAMADOL HYDROCHLORIDE.

0.06

Kg.

FUJIKAWA AND CO LTD

Japan

MESALAMINE

9.99

Kg.

NIHON PHARMACEUTICAL INDUSTRY CO

Japan

MESALAMINE

10

Kg.

KOBAYASHI KAKO CO LTD

Japan

ATOMOXETINE HYDROCHLORIDE

14.75

Kg.

TATEYAMA KASEI CO LTD

Japan

MELOXICAM USP

8.9

Kg.

APOTEX INC

Canada

 

  • Saroglitazar (trade name Lipaglyn) is a drug for the treatment of type 2 diabetes mellitus and dyslipidaemia. It is approved for use in India
  • Saroglitazar is a key research product of Cadila. The company has been researching on the drug to treat fatty liver disease or non-alcoholic steatohepatitis (NASH) apart from diabetic dyslipidaemia. 
  •  In November 2015, Zydus Cadila received approval from the US FDA to conduct Phase II studies for dyslipidaemia and in early 2016 it was cleared for Phase II studies in NASH (EVIDENCES VI trials).
  • From export database and recent shipments of Saroglitazar to US, about APIs and vias, it is interesting to note perhaps Saroglitazar is being revived. Cadila could be finding encouraging results in EVIDENCES study. Trial outcome is expected soon.
  • The global non-alcoholic steatohepatitis (NASH) market  is projected to reach $21 billion by 2025. There are not many approved therapies for NASH. This market could be shared by below few prominent options, not all these therapies are approved for treatment of NASH though.
    • Vitamin E & Pioglitazone
    • Ocaliva
    • Elafibranor
    • Selonsertib & Cenicriviroc
  • In IP analysis of Cadia we reported US granted patent for composition for treatment for NASH. US 9,814, 697 B2, granted in November 2017. Positive Phase I study and on-going PII studies along with sample shipments to US, one could conclude Cadila is very enthusiastic about their US approval of Saroglitazar for NASH.
  • Though objective of this newsletter is not a detailed financial analysis, it would be important information for analysts for the valuations.
  • Halobetasol propionate is under development Novum US Las Vegas NV, Fargo ND. Few Gxs (ANDAs) are already approved such as Sun, Perrigo and Fougera. Cadila would be one among them upon approval.
  • Second interesting point to note, very small quantity of shipments of tramadol, atomoxetine, glibenclamide and donepezil to Japan. In Japan Cadila so far has only one DMF ie amlodipine. So Cadila is concentrating in Japan market and very soon must be filing DMFs for these three four products in Japan.
  • Meloxicam export to Canada also suggests Cadila is concentrating in registration of APIs in Canada.

General information

Change in Data Exclusivity for Pharmaceutical Products in the United Arab Emirates

https://www.lexology.com/library/detail.aspx?g=f3ddb9d9-f84d-44b0-bfdb-1cefa611df7c

In UAE, decree 321 sets a data exclusivity period of 8 years from the date of marketing approval (Data Exclusivity Period) for innovative pharmaceutical products which contain an active pharmaceutical ingredient for which no other pharmaceutical product has obtained a marketing license in the UAE. According to Decree 321, generic and biosimilar companies can apply for marketing approval within the last 2 years of the end of the Data Exclusivity Period

Nigerian drug regulator blacklists Gujarat pharma company for ‘substandard’ antibiotics

https://theprint.in/health/nigerian-drug-regulator-blacklists-gujarat-pharma-company-for-substandard-antibiotics/526923/

In a letter written to Mars Remedies on 9 October, the NAFDAC said the company manufactured “falsified” Ciprofloxacin 500mg tablets. The letter was also marked to Dr V.G. Somani, Drugs Controller General of India (DCGI).

Intellectual Property

The Patent (Amendment) Rules 2020 (Revised Rules 2020) have come into force from 20 October 2020 in India.

http://www.ipindia.nic.in/writereaddata/Portal/Images/pdf/patents_amendment_rules_2020.pdf

New Rules:

1. Filing of Priority Document in case of Indian National Phase applications (Rule 21)

Filing of priority document and English translation (if applicable) for Indian national phase patent applications has been amended to include certain PCT regulations.

Previously, an English translation had to be filed whenever the priority document was not in English. With new rules, an English translation must be filed within 31 months from the priority date, i.e., at the time of entry into national phase in India. If this requirement is not met, the Patent Office shall invite for submission of the priority document or translation thereof and the same must be filed within 3 months from such invitation, else the priority will be disregarded. 

2. Submission of Working Statement (Rule 131) and Amendment in Form 27

The Indian Patent Act obligates each patentee to furnish details of the “extent of working” of the patented Invention in accordance to provisions under Section146 (1) read with Rule 131. The appropriate Format for furnishing Information about working of Patent is prescribed in Form 27. There are amendments in Rule 131 and Form 27, which would be effective from 20 October 2020.

The new rule states that a working statement must be furnished once for every financial year (1 April to 31 March) within 6 months from the start of the following financial year i.e. by 30 September of the following year.

Previously the rule required submission of working statement in respect of every calendar year within three months of the end of each year. 

Few amendments in Form 27:

  • Provision has been made to include multiple patents by the same patentee/licensee (provided they are related) which have been worked together and details of all such patents and the total amount of the same to be provided.

  • Separate provision has been provided for all such patents worked and not worked and value accrued in INR to be provided for manufacturing as well as importing for each separately.

  • For patents worked details are to be provided in 500 words and for patents not worked details are to be provided in 500 words.




Disclaimer: 
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.



Location: Mumbai, Maharashtra, India

Popular posts from this blog

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic and Trademark case for J&J's ORS-L brand (Delhi HC decision)

Image
  Contents List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic General information Unicycive Therapeutics, Inc. Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology Weak regulation causing deaths due to contaminated medicines, WHO says Intellectual Property Delhi HC Trademark decision registered marks for ORS-L and ORSL List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic The FDA maintains a list of approved new drug applications (NDAs) that are no longer under patent or exclusivity and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA. The list is updated every six months (in June and December) to enhance transparency and promote the development and submission of ANDAs in markets with limited competition. The June list was published recently and can be found here . Some oral dosage formulations for which the ...
Read more

API and IP Newsletter- Recent ANDA approvals and Roxadustat decision by EPO: T 0072/23

Image
Contents Recent ANDA approvals General information Jazz pays $145m to resolve Xyrem antitrust disputes Bristol Myers Freed From Blood Cancer Drug Antitrust Litigation Intellectual Property Roxadustat decision: T 0072/23 (Photostable roxadustat formulation/FIBROGEN) Recent ANDA approvals We track ANDA approvals monthly. This report discusses the ANDA approvals obtained by generic companies in March 2025. There are approximately 86 ANDA approvals for March 2025, of which 23 are tentative approvals. Interestingly, out of the total 86 approvals, 47 were received by Indian companies.  Below is the list of top ANDA approvals. Some of our observations for the approved products are as follows. General information Jazz pays $145m to resolve Xyrem antitrust disputes Jazz Pharma has agreed to pay $145 million to settle lawsuits claiming it illegally acted to prevent generic versions of its narcolepsy therapy Xyrem from entering the US market. The lawsuits – which date back to 2020...
Read more

DMF filings by Indian companies in May 2025 and F-Hoffmann-La Roche AG Vs Zydus Lifesciences Limited- Delhi High Court decision

Image
Contents DMF filings by Indian companies General information The Central Drugs Standard Control Organisation(CDSCO) issued a circular for Nitrosamines in Ranitidine Novo Nordisk files 14 new lawsuits against unapproved semaglutide drugs Intellectual Property                F-Hoffmann-La Roche AG Vs Zydus Lifesciences Limited- Delhi High Court DMF filings by Indian companies We monitor DMF filings each quarter. The USFDA recently published the list of DMF filings for the second quarter of 2025. This week, we will review the DMFs filed in May 2025. A total of 82 DMFs were filed in May 2025, with 29 filed by Indian companies and 41 by Chinese companies. Not many Indian companies are at the top of the DMF filing list. Chinese companies have long overtaken Indian companies in the DMF filing race. Now, Chinese companies consistently file more DMFs than Indian companies each quarter. General information The Central Drugs Standard Control ...
Read more