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DMFs filed in January 2023
FDA publishes a quarterly list of DMFs filed by various API manufactures. We analyze those. Type II DMFs. We study DMFs filed by Indian companies.
In the month of January about 50 DMFs were filed and as usual 50% of those were Indians. Some of our observations are as below.
HOLDER | SUBJECT | SIDVIM Comments |
|---|
EVEREST ORGANICS LTD | BEMPEDOIC ACID | Total 9 DMFs filed so far for bempedoic acid. In February 2020, the FDA approved Esperion's bempedoic acid under the brand name Nexletol. It is used to treat high BP. There could be many ANDA filers on NCE-1 date in February 2024. |
AURO PEPTIDES LTD | LIRAGLUTIDE | There are over 20 DMFs for liraglutide. It is an anti-diabetic medication used to treat type 2 diabetes, and chronic obesity. As per settlement dates Generic could able to launch by mid-2024. It is low volume, high value API. |
CIPLA LTD | Difelikefalin Acetate | Difelikefalin was approved for medical use in the United States in August 2021. The first DMF was filed by Cipla. Difelikefalin, sold under the brand name Korsuva, is an analgesic opioid peptide used for the treatment of moderate to severe itching. |
AMI LIFESCIENCES PRIVATE LTD | SEVELAMER CARBONATE | There are about 2 dozen active DMFs for this old product. Sevelamer is marketed by Sanofi under the brand names Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate). It is used to treat hyperphosphatemia in patients with chronic kidney disease. Sevelamer carbonate is mainly used to treat high blood phosphorous levels (hyperphosphatemia) in dogs and cats with chronic kidney disease. |
IOL CP | ALLOPURINOL USP | Allopurinol is an old product. Reasonably high volume API. It is priced at USD 35-45/Kg. Allopurinol is a medication used to decrease high blood uric acid levels. |
General information
New magic weight loss drug? Mounjaro controls diabetes and tackles obesity at the same time. Why it’s better than Semaglutide
Tirzepatide is superior to Semaglutide in reducing HbA1c levels and preventing hypoglycemia. ‘Weight-loss surgery will be a thing of the past, it will be out of the medical books even,’ says Prof Surender Kumar, Dept of Endocrinology and Metabolism, Sir Ganga Ram Hospital, Delhi
News here.
Moderna Partners With IBM, Hoping AI Can Help Develop More mRNA Medicine
Moderna said the deal will help the company “explore next generation technologies” like artificial intelligence and quantum computing to advance and accelerate its mRNA research.
mRNA, or messenger RNA, are a group of small molecules that shuttle genetic information from the DNA in cells to cellular machinery that makes proteins, a process companies like Moderna are trying to exploit to create new drugs and vaccines.
News here
Intellectual Property
Claim construction in US District Court; Newron and Co Vs MSN and others.
Claim construction hearing is a pre-trial hearing in a U.S. District Court.
The judge examines evidence from all parties on the appropriate meanings of relevant keywords used in a patent claim when patent infringement is alleged by patentee. It is also known as Markman hearing.
Today we are covering an example for claim construction hearing.
In this action filed by Newron Pharmaceuticals S.p.A., Zambon S.p.A., and MDD US Operations, LLC (Newron and Co) against MSN, RK Pharma Inc., Prinston Pharmaceutical, Inc., and Prinston Pharmaceutical, Inc., and Zenara Pharma Private Limited. Newron and Co alleged infringement of US 8,076,515, US 8,278,485 , and US 8,283,380. The Court dealt with issue of claim construction of multiple terms in these patents.
These are the patents listed in OB for Safinamide.
In below table it is interesting to note how court construed the claims.
Agreed-Upon Constructions |
|
|---|
Claim Term | Court's Construction |
|---|
"an effective amount" (' 515 patent, claim 40) | "an amount sufficient to treat the selected CNS disorder" |
"classified as"
(' 515 patent, claim 44) | Plain and ordinary meaning, with leave to renew indefiniteness |
"are known to interact with" (' 515 patent, claim 44) | Plain and ordinary meaning, with leave to renew indefiniteness |
"are known to have HERG channel blocking properties"
(' 515 patent, claim 44) | Plain and ordinary meaning, with leave to renew indefiniteness |
Disputed Constructions |
|
|---|
Claim Term | Court's Construction |
|---|
"stable dose of levodopa"
('380 patent, claims 1-2) | "a dose of levodopa that is neither increased
nor decreased" |
"maintaining"
(' 380 patent, claim 1) | Plain and ordinary meaning, which is
"keeping" |
"a therapeutically effective stable dose of
levodopa" ('380 patent, claim 2) | "a dose of levodopa sufficient to treat
idiopathic Parkinson's disease that is neither
increased nor decreased" |
"high purity safinamide or ralfinamide or a
pharmaceutically acceptable acid salt
thereof'/"high purity safinamide or
ralfinamide salt with a pharmaceutically
acceptable acid" /"high purity safinamide or a
pharmaceutically acceptable acid salt thereof'
(' 515 patent, claims 32-35, 40-44; '485
patent, claim 3 7) | "safinamide or ralfinamide or a
pharmaceutically acceptable acid salt thereof
that has lower than 0.03% (by weight) of
impurity Ila7 or impurity Ilb8 or their
pharmaceutically acceptable acid salts" and
not indefinite |
Decision here
