Contents
DMFs filed in May 2021.
General information.
Novartis may have the most new drug approvals, but Roche, Lilly and AbbVie's launches win on value.
Biden’s competition order directs FDA on biosimilars, importation and OTC hearing aids.
Intellectual Property.
DMFs filed in May 2021
In SIDVIM, we analyze DMFs filings by Indian companies every quarter. This week we analyzed DMFs filed in the month of May 2021. Few representative cases are presented here.
HOLDER | SUBJECT | SIDVIM comments |
MSN LABORATORIES PRIVATE LTD | MOLNUPIRAVIR | Third DMF. Many more DMFs would be expected soon. |
METROCHEM API PRIVATE LTD | TOFACITINIB CITRATE | Too many other DMFs. Nothing very specific here. Crystalline form patent till 2026. |
DR REDDYS LABORATORIES LTD | ERIBULIN FRAGMENT-A | First Indian DMF! Gx launch possible in US in 2023. |
CIPLA LTD | BICTEGRAVIR SODIUM | Fourth DMF and NCE-1 date in July 2022. One can expect many ANDA filers on NCE-1 date. |
ASHA CELLULOSE (I) PVT LTD | ASHAKOTE - ETHYLCELLULOSE AQUEOUS DISPERSION | Many DMFs |
SUNPURE EXTRACTS PVT LTD | CURCUMIN EXTRACT 95% | This is interesting, first DMF for curcumin after 12 years. |
SUNPURE EXTRACTS PVT LTD | LUTEIN POWDER 20% (ZEAXANTHIN 4%) | First company to file DMF. Lutein is synthesized only by plant extracts. |
CENTAUR PHARMACEUTICALS PRIVATE LTD | TRIAZOLAM USP | First DMF. Very old approval. An interesting selection of this tranquilizer by Centaur. |
SUN PHARMACEUTICAL INDUSTRIES LTD | PANTOPRAZOLE SODIUM USP (PROCESS II) | Several DMFs, several processes. Must be either customer specific DMF or for their own ANDA |
OPTIMUS DRUGS PRIVATE LTD | FAVIPIRAVIR | Every month one DMF is being filed for Favipiravir. |
MSN LIFE SCIENCES PRIVATE LTD | REMDESIVIR | First DMF filed. What is going to happen to this DMF with present status of Remdesivir in Covid treatment? |
MICRO LABS LTD | TORSEMIDE USP | First DMF filed after 2013. Several ANDA filers too. |
MOREPEN LABORATORIES LTD | APIXABAN FORM H3 | Fourth DMF, product will become generic in 2022. Everyone is filing DMF with different crystalline form. Though Gxs are litigating, Gx launch should be possible in 2026 in US and 2023 in RoW. |
General information
Novartis may have the most new drug approvals, but Roche, Lilly and AbbVie's launches win on value
In the last five years, the world’s top 11 drugmakers have brought 76 new meds to market, Evaluate Vantage said in a recent report. Novartis sits pretty in the No. 1 spot with a dozen green lights to its name, including those for gene therapy Zolgensma and the first-ever approved CAR T-cell therapy, Kymriah. Bristol Myers Squibb rounds out last place with just three—and all of them courtesy of its $74 billion Celgene buyout. (Read more)
Biden’s competition order directs FDA on biosimilars, importation and OTC hearing aids
“Just a handful of companies control the market for many vital medicines, giving them leverage over everyone else to charge whatever they want. As a result, Americans pay two and a half times more for prescription drugs than in any other leading country. And nearly one in four Americans struggles to afford their medication,” Biden said.
One such policy includes revisiting prescription drug importation from Canada, where prices are cheaper than in the US, by instructing the FDA Commissioner to work with states and tribes that propose to develop section 804 importation programs. (Read more)
Intellectual Property
Entresto (Sacubitril/Valsartan) claim construction patent litigation
Following are OB listed patents.
Patent No | Patent Expiration | Drug Substance | Drug Product | Patent Use Code | Submission Date |
7468390 | 11/27/2023 |
| DP |
| 08/06/2015 |
7468390*PED | 05/27/2024 |
|
|
|
|
8101659 | 01/14/2023 |
| DP |
| 08/06/2015 |
8101659*PED | 07/14/2023 |
|
|
|
|
8404744 | 01/14/2023 |
| DP |
| 08/06/2015 |
8404744*PED | 07/14/2023 |
|
|
|
|
8796331 | 01/14/2023 |
|
| U-1723 | 08/06/2015 |
8796331*PED | 07/14/2023 |
|
|
|
|
8877938 | 05/27/2027 | DS | DP |
| 08/06/2015 |
8877938*PED | 11/27/2027 |
|
|
|
|
9388134 | 11/08/2026 |
|
| U-1723 | 09/07/2016 |
9388134*PED | 05/08/2027 |
|
|
|
|
9517226 | 08/22/2033 |
|
| U-3084 | 03/16/2021 |
9937143 | 08/22/2033 |
|
| U-3084 | 03/16/2021 |
11058667 | 05/09/2036 |
|
| U-3170 | 07/13/2021 |
Novartis sued multiple Gx filers (total 17!!) alleging infringement of US 8,101,659; US 8,796,331; US 8,877,938; and US 9,388,134. This was a claim construction litigation.
There are three issues for the Court to decide with respect to the "trisodium [sacubitril-valsartan] hemipentahydrate" and "in crystalline form" limitations:
1. Is "trisodium [sacubitril-valsartan] hemipentahydrate" by itself limited to crystalline form?
2. Are the claim terms "trisodium [sacubitril-valsartan] hemipentahydrate" and "crystalline form" limited to "a... supramolecular complex having formula units ..., wherein each formula unit in a unit cell... has 2.5 water molecules and 3 sodium ions"? and
3. Are the '134 Patent claims limited to "substantially pure" trisodium [sacubitril-valsartan] hemipentahydrate?
Claim Term | Claims | Court's construction |
"amounts effective to treat hypertension or heart failure" | 659 patent, claim 2 | "amounts of each component sufficient in combination to treat hypertension or heart failure" |
"therapeutically effective amount | 331 patent, claim 1; '134 patent, claim 1 | "amount sufficient to treat heart failure or hypertension" |
"effective amount" | 938 patent, claim 11 | "amount sufficient to have a therapeutic effect" |
"wherein said (i) ...and said (ii) ... Are administered in combination"/ "administering...the combination of:(i)...; (ii)...; and wherein said components (i) and (ii) are administered in one unit dose form or in two separate unit dose forms" | 659 patent, claim 1; '331 patent, claim 1 | "wherein said (i) ... and said (ii)..., are administered in combination / administering ... the combination of: (i) ...; (ii)...; and wherein said components (i) and (ii) are administered in one unit dose form or in two separate unit dose forms" |
"trisodium [3-((lS,3R)-l-biphenyl-4-ylmethyl-3- ethoxycarbonyl-1- butylcarbamoyl) 1-propionate-(S)-3-methyl-2'-(pentaiioyl{2"-(tetrazol-5-ylate)biphenyl-4 yhnethyl}ammo) butyrate] hemipentahydrate in crystalline form'' | 938 patent, claim 1 | "substantially pure trisodium [sacubitril-valsartan] hemipentahydrate in crystalline form" |
"trisodium [3- ((lS,3R)-l-biphenyl-4-ylmethyl-3- ethoxycarbonyl-1-butylcarbamoyl) propionate-(S)-3 methyl-2'-(pentanoyl{2"-(tetrazol-5-ylate) biphenyl-4'-ylmethyl} amino)butyrate] hemipentahydrate" | 134 patent, Claim 5,11 and 13,15 | "trisodium [sacubitril-valsartan] hemipentahydrate" |
"trisodium [3- ((lS,3R)-l-biphenyl-4-ylmethyl-3- ethoxycarbonyl-1-butylcarbamoyl) propionate-(S)-3 methyl-2'-(pentanoyl{2"-(tetrazol-5-ylate) biphenyl-4'-ylmethyl} amino)butyrate] hemipentahydrate" | 135 patent, Claim 1,4 | "substantially pure trisodium [sacubitril-valsartan] hemipentahydrate in crystalline form" |
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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.
