API and IP Newsletter

      

Contents

• A brief analysis of USDMFs filed by Indian companies in July 2020. 

• General information. 

• Dr Reddy's to launch 30 more products in US market this year 

• FDA clarifies reference-listed drugs, other ANDA terms in final guidance. 

• China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs 

• Intellectual Property. 

• NL – NOVARTIS V. MYLAN / DEFERASIROX (Exjade)  

 

A brief analysis of USDMFs filed by Indian companies in July 2020

DMF list is updated every quarter at USFDA website. It is updated till September 2020 for the months, July, August and September.  This week, we have analyzed DMFs filed by Indian companies in July 2020. In subsequent Newsletters, we will cover the other months.

In July 2020, 50 DMFs were filed in total, out of which 25 DMFs were filed by Indian companies. Century Pharmaceuticals filed 5 DMFs, Biocon, Cadila Pharmaceutical, Cadila Healthcare filed 2 each. The objective of this newsletter is not to state mere statistics but to provide technical insights.

HOLDER	SUBJECT	SIDVIM insights
MSN LABORATORIES PRIVATE LTD	ISOSULFAN BLUE	Mylan, Aurobindo filed ANDA, there could be few other ANDA filers soon. Interestingly, brand discontinued the product. This could be exciting product for Gx, brand has not withdrawn for safety reason and according to FDA, Gx could continue with REMS (Risk Evaluation and mitigation).
BIOCON LTD	LENALIDOMIDE	Biocon has not exported to anyone, but Matrix exported to Hikma in US at USD 25.000/Kg
BIOCON LTD	SITAGLIPTIN PHOSPHATE MONOHYDRATE	Biocon does not seem to be exporting commercial quantities but other Indian companies such as SMS, Morepen are routinely exporting to Europe.
ALEMBIC PHARMACEUTICALS LTD	AZITHROMYCIN DIHYDRATE USP (ADF PROCESS)	Alembic is exporting all around the word, price range USD 175-300/Kg, depending upon country and quantity. Information about ADF process to be found out.
BIOPHORE INDIA PHARMACEUTICALS PVT LTD	GADOTERIDOL	Biophore is the only DMF holder for this product. Used in diagnostics.
MANKIND PHARMA LTD	CLOMIPRAMINE HYDROCHLORIDE USP	Mankind is already supplying capsules to US, now they perhaps would shift to their own API.
KALINTIS HEALTHCARE PVT LTD	BENZTROPINE MESYLATE USP	4 other DMFs active, but no DMF from any frontline Gx company.
CADILA HEALTHCARE LTD	PIMAVANSERIN TARTRATE	4 other DMFs are active, but Gx launch looks difficult before 2028.
VANDANA LIFE SCIENCES PRIVATE LTD	LAMIVUDINE COUPLED ESTER (NON-STERILE DRUG INTERMEDIATE)	Intermediate
AUROBINDO PHARMA LTD	FOSCARNET SODIUM USP	More than 5 DMF holders. Very old approval. No Gx. Hospira withdrew, maybe Aurobindo would launch Gx.
CENTURY PHARMACEUTICALS LTD	ROXITHROMYCIN BP	Several DMF
CENTURY PHARMACEUTICALS LTD	OXYTETRACYCLINE HYDROCHLORIDE USP	There are few DMFs, no Indian DMF holder, but interestingly product is discontinued by FDA.
CENTURY PHARMACEUTICALS LTD	DORZOLAMIDE HYDROCHLORIDE USP	Several DMFs. Century is exporting USD 3000-4000/Kg in small quantities to less regulated markets.
CENTURY PHARMACEUTICALS LTD	ERYTHROMYCIN ESTOLATE USP	Several DMFs
CENTURY PHARMACEUTICALS LTD	CLARITHROMYCIN USP	Several DMFs
HETERO LABS LTD	PEMETREXED DISODIUM 2.5 HYDRATE	Many DMFs. Launch could be possible in 2022. Few Indian companies are selling API in Europe in 20-30 kilo quantity at USD 25,000/Kg
AGNO PHARMA	ISOSULFAN BLUE	CRO, Manufacturing in Singapore
AARTI INDUSTRIES LTD	FLUTICASONE FUROATE	Many DMFs
METROCHEM API PRIVATE LTD	LURASIDONE HYDROCHLORIDE	Many DMFs
CADILA PHARMACEUTICALS LTD	GEMFIBROZIL USP	Many DMFs & ANDAs. Indian companies are exporting at about USD 50/Kg.
AUROBINDO PHARMA LTD	PALIPERIDONE USP	Many DMFs & ANDAs. Still, Indian companies exporting API at USD 4000-6000/Kg. A reason for such high prices to be studied.
CADILA HEALTHCARE LTD	ELTROMBOPAG OLAMINE	4 active DMFs, MSN, Hetero are selling to EU, and other less regulated markets at very high price, in single digit kilogram quantities. Generic launch is not at sight and perhaps should not be possible before May 2023.
CADILA PHARMACEUTICALS LTD	HYDRALAZINE HYDROCHLORIDE USP	Several DMFs and ANDAs, including Cadila. Many companies are selling at around USD 150-180/Kg
UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD)	GLIPIZIDE USP	Several DMFs. Many companies are exporting USD 250-300/Kg
ZCL CHEMICALS LTD	Apixaban	Several DMFs, Generic launches could be in 2022.

General information

Dr Reddy's to launch 30 more products in US market this year

Dr Reddy's Laboratories is set to launch 30 more products in the US market this year, said Saumen Chakraborty, President, CFO & Global Head-IT at DRL, after the company beat estimates in the second quarter with growth seen across geographies. On API, he said, “Active pharmaceutical ingredient (API) and service business has high growth potential. (Read more)

FDA clarifies reference-listed drugs, other ANDA terms in final guidance

Generic drug makers have received finalized guidance from the US Food and Drug Administration. In finalizing a 2017 draft, the agency gives sponsors of abbreviated new drug applications (ANDAs) information about how to identify reference listed drugs (RLDs), further details on reference standards, and what forms the basis for an ANDA submission. (Read more)

Guideline could be downloaded here

China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs

The first applicant with a small molecule generic product that successfully challenges a reference drug patent receives a 12-month exclusivity period against approval of another generic version of the same drug. (Read more)

Intellectual Property

 NL – NOVARTIS V. MYLAN / DEFERASIROX (Exjade)

 

Fact:

Granted patent EP 0914 118

In Europe, as a practice, innovator companies would send Warning Letters (WL) to Gx companies. Novartis would have sent WL to Mylan, citing their patent EP 0914 118. On 10 June 2020, Mylan responded that they would not honor pediatric extension term and could launch on 30 August 2021.  Mylan challenged validity of pediatric extension (PIP) and alleged it (PIP) is not valid. 

Novartis sought preliminary injunctions against Mylan to essentially stop them from marketing the Deferasirox (Brand name: Exjade) prior to expiry of the Paediatric Extension (PIP) for Exjade.

The twist in the tale was that Exjade had received an orphan designation from the European Commission in 2002, but this designation was unilaterally revoked by Novartis in 2016.

It is important to note, for conducting paediatric study, innovator could get either,

 

Regulations here

Novartis opted for 1st option above. Mylan argued, the Paediatric Extension is invalid in this case, arguing that Exjade had previously been designated as an orphan drug, in theory entitling it to an extension of the regulatory market exclusivity with two years. And in Mylan’s view, 6-months PIP extension after SPC is invalid.

Judge opined in favour of Novartis, held that there is no double reward for paediatric studies, since due to the expiration of orphan drug designation, no market exclusivity extension has been granted. Detailed case here.

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.