Rolapitant hydrochloride

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

3 API Suppliers, 1 USDMF, 2 NDC API, 3 Listed Suppliers

INTERMEDIATES

7 Suppliers

7 Suppliers

DOSSIERs // Finished Dosage Formulations

2 Dossiers, 2 FDA Orange Book

DRUG PRODUCT COMPOSITION

TABLET;ORAL - EQ 90MG BASE, EMULSION;INTRAVENOUS - EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

TABLET;ORAL - EQ 90MG BASE
EMULSION;INTRAVENOUS - EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

RELATED EXCIPIENT COMPANIES

Suppliers, 21 BASF, 21 Kerry, 16 Roquette, 11 Sigachi Industries, 11 Gangwal Chemicals, 10 Microlex e.U, 8 Gangwal Healthcare, 8 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 Seppic, 5 DFE Pharma, 5 Corel Pharma Chem, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 SPI Pharma, 3 Ingredion Pharma Solutions, 3 Prachin Chemical, 3 Ideal Cures Pvt Ltd, 3 Nanjing Well Pharmaceutical, 3 Vasa Pharmachem, 2 Pharmatrans-Sanaq, 2 Nomisma Healthcare, 2 Seqens, 2 Jai Radhe Sales, 1 Nanjing Bold Chemical, 1 Boai NKY Pharmaceuticals Ltd, 1 DKSH, 1 Aeon Procare, 1 Finar, 1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders, 26 Direct Compression, 24 Solubilizers, 22 Disintegrants & Superdisintegrants, 19 Coating Systems & Additives, 17 Controlled & Modified Release, 17 Thickeners and Stabilizers, 17 Granulation, 15 Parenteral, 13 Lubricants & Glidants, 12 Topical, 11 Co-Processed Excipients, 6 Film Formers & Plasticizers, 6 Taste Masking, 5 Emulsifying Agents, 5 Chewable & Orodispersible Aids, 3 Rheology Modifiers, 3 API Stability Enhancers, 2 Surfactant & Foaming Agents

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions

6 US Medicaid Prescriptions

MARKET PLACE

5 APIs

5 APIs

PATENTS

13 US Patents

13 US Patents

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow, 11 News

Blog

Full Screen View

DMF submissions in 2020: Industry sustains its filing momentum

In case you thought Covid-19 had slowed down the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA), you are in for a pleasant surprise. During the first half of this year, the industry maintained its momentum of filing DMFs with the FDA. In the first six months of this year, FDA received 283 DMF submissions (against 616 for the full year of 2019). Expectedly, India continued to lead with 155 DMF filings. Submissions from India were more than double the amount of those made by Chinese (45) and American firms (30) combined. This trend has been witnessed for some time now. In 2019, out of the 616 active DMF submissions to the FDA, Indian companies had submitted more than half (331), though the submissions from India were a little less than double of those made by Chinese and American firms. Drug master files (DMFs) are submissions made to the FDA by manufacturers who provide the agency with confidential, detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing of human drug products.View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available) India’s MSN Labs leads total count of DMF filings As in the past, India’s MSN Laboratories continued to lead the DMF filings by a single company with 40 submissions, followed by Dr Reddy’s (8) and Metrochem API (7). MSN has always been a pioneer in being the first to file a DMF for new products. This year was no different. The firm submitted the first DMF for 11 products — Abaloparatide, Abemaciclib, Amifampridine Phosphate, Betrixaban Maleate, Fenfluramine Hydrochloride, Lofexidine Hydrochloride, Neratinib Maleate, Ozenoxacin, Rolapitant Hydrochloride, Tafamidis, Valbenazine Tosylate. There were also first DMF filings by AMRI (Brexanolone), Formosa Laboratories (Elagolix Sodium), Glenmark Life Sciences (Solriamfetol Hydrochloride) and Hikal (Ertugliflozin L-Pyroglutamic Acid). The API DMF is part of the final generic drug product submission to the FDA. Therefore, the owner of a DMF incurs a one-time fee, the first time the generic drug submission references that DMF. DMF holders may also pay the fee in advance in order to have their DMF subjected to an initial completeness assessment by the FDA. This would allow their DMF to be included on a publicly available list of DMFs that have paid their fee and have not failed the initial completeness assessment. View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available) Assessment review of only 62 DMFs completed by the FDA While 283 DMFs were submitted to the FDA, only 22 percent of them — or 62 DMFs — have had their assessment review completed by the FDA so far. The GDUFA fee associated with a DMF assessment review for the current fiscal year is US$ 57,795. It has been revised upward to US$ 69,921 (an increase of US$ 12,126) for the upcoming fiscal year, which starts in October. Although MSN led in the number of DMF filings, it had no assessments completed for its DMF submissions in the first half of the year. Three Indian companies, Aurobindo, Honour Lab and Intas, and one Chinese company, Jiangsu Hengrui, led in the maximum (three each) number of assessments completed by the FDA. The products with the most commonly filed DMFs were Brivaracetam, Cetrorelix, Edaravone and Lifitegrast, with four submissions each. DMF filings also help provide insights into some of the new drug approvals that can be expected in the future. In the first half of the year, we witnessed submissions for Dapoxetine Hydrochloride (MSN), Fasoracetam (MSN), Indoximod (MSN), Resiniferatoxin (Indena), Omidenepag Isopropyl (UBE Industries), Treosulphan (Fermion), Roxadustat (Dr Reddy’s), Bexagliflozin (Piramal), Antazoline Phosphate (Metrochem) and Dyphylline (Shanghai Wonder) which are all products that have currently not been approved by the FDA and could potentially be approved in the future.View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available) Our view The Covid crisis and the surging demand for APIs like hydroxychloroquine, favipiravir and dexamethasone has revealed the global dependence on India and China for APIs. India, a prominent API manufacturer, admitted to its extreme dependence on China for APIs and intermediates when it shared a list of products which included antibiotics, vitamins, hormones and even commonly used medicines like aspirin and paracetamol. In July this year, India announced the guidelines for its schemes for the development of bulk drugs and medical device parks across the country. These schemes are part of India’s self-reliance campaign. Similar reshoring initiatives have been announced by the United States, France and Japan, and many other countries also want to reduce their reliance on China. While shifting supply chains is certainly a long drawn out process, the wheels have definitely started to turn. It remains to be seen what impact these initiatives will have on the DMF filings with the FDA in the next few quarters. View FDA DMF Filings by June 2020 (Power BI Dashboard, Free Excel Available)

Impressions: 58663

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03 Sep 2020

FDA’s Drug Approvals in 2015: Novel Drugs & New Versions of Existing Drugs

Each year, the US Food and Drug Administration (FDA) approve hundreds of new medications. A small subset of approvals, classified as novel drugs, are considered to be truly innovative products that often help advance clinical care. In 2015, the FDA approved 45 novel drugs, an all-time record high. PharmaCompass has compiled a list of novel drugs approved by the FDA in 2015.The FDA also approved new dosage forms of existing products in the market (email us if you would like a copy), like the 3D printed version of anti-epilepsy drug, Spritam (Levetiracetam). This week, PharmaCompass focuses on the new dosage forms of existing drugs that got approved last year. Modified blockbusters Improving the delivery form of a blockbuster drug is something that not only helps patients but often successfully extends the patent life of the cash-generating drugs for Big Pharma. Here are some blockbuster drugs that saw their modified versions being launched in 2015: Jadenu (deferasirox): With almost a billion dollars in revenues in 2015, Exjade (deferasirox) was approved in 2005 as a tablet for use in a suspension. Novartis, the innovator, got approval in March 2015 for Jadenu, a once-daily oral tablet. Jadenu (deferasirox), a new formulation of Exjade, is the only once-daily oral tablet for iron chelation. Jadenu has simplified daily treatment administration for patients with chronic iron overload. Nexium 24HR (esomeprazole magnesium): Also known as the Purple Pill, Nexium – Astra Zeneca’s blockbuster drug for acid reflux that generated annual sales in America of more than US $ 3 billion – went generic in 2015. In order to extend Nexium’s market, Pfizer and AstraZeneca came together to promote an over-the-counter (OTC) version of Nexium. A capsule version of OTC Nexium was approved in 2014 and is known as Nexium 24HR. Last year, the FDA granted approval to the tablet form of the drug. Iressa (gefitinib): AstraZeneca re-introduced Iressa in the US market in 2015. The FDA had approved Gefitinib in May 2003 for non-small cell lung cancer. Approved as a third-line therapy, in 2010 the FDA requested AstraZeneca to voluntarily withdraw Iressa tablets from the market, as post-marketing studies had failed to verify and confirm clinical benefit. Iressa (gefitinib) is now back in the US as a first-line therapy for a type of lung cancer. However, the patent protection is limited – only one listed patent in the Orange Book which expires next year, and five US Drug Master Files already submitted. Onivyde (irinotecan): Liposomal formulation of anti-cancer drugs have been in vogue for some time. Merrimack Pharmaceuticals got its novel encapsulation of Irinotecan in a liposomal formulation approved for the treatment of patients with metastatic pancreatic cancer, sold under the brand name Onivyde. Vivlodex (meloxicam): In October 2015, the FDA approved 5 mg and 10 mg (administered once daily) doses of Vivlodex™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for the management of osteoarthritis pain. The previously approved doses for meloxicam capsules were 7.5mg and 15mg. Vivlodex uses a proprietary SoluMatrix Fine Particle Technology™, which contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. Kalydeco (ivacaftor): A cystic fibrosis drug from Vertex Pharmaceuticals – Kalydeco – has been making headlines because of its high price (more than US $ 300,000 a year). Price concerns aside, 2015 saw the launch of a pediatric version of the drug as a ‘weight-based oral granule formulation of Kalydeco that can be mixed in soft foods or liquids’. Extended release versions Many of the approvals granted by the FDA last year were to extended release formulations (a pill formulated so that the drug is released slowly) of existing drugs. Kremers Urban’s extended release version of Methylphenidate capsules made headlines last year because of a reclassification of the drug by the FDA. Under the new classification rating, methylphenidate hydrochloride extended-release tablets can be prescribed but may not be automatically substituted for J&J’s reference drug Concerta (methylphenidate hydrochloride). Kremers Urban was almost sold last year. But due to this reclassification, investors aborted their US $ 1.53 billion buyout. Kremers Urban was later acquired by Lannett Company Inc. In addition, extended-release versions of Aspirin, Carbidopa/Levodopa, Paliperidone Palmitate, Tacrolimus and Morphine Sulphate also received green signals for a market launch. First generic opportunities Last year, PharmaCompass shared the names of some drugs which had no generic competition and were also not protected by patents. (Read: “Litigation Free, first generic opportunities list”). Deferiprone (a drug that chelates iron and is used to treat iron overload in thalassemia major) met the criteria. But it still has no generic competitor and is now available as a new dosage form. Amedra Pharmaceuticals, now owned by Impax Laboratories, has enjoyed the rights to sell Albendazole tablets for almost two decades without generic competition in the US. Albendazole is a medication used for the treatment of a variety of parasitic worm infestations. In 2015, patients were provided access to chewable tablets of Albendazole. New combinations at work The FDA also approved multiple combination drugs where the individual active ingredients had been brought to market previously. Most of the combination drugs approved belong to major pharma players like Novartis, Novo Nordisk, Bristol Myers etc. Boehringer’s diabetes treatments – Jardiance (empagliflozin) – approved in 2014 and Tradjenta (linagliptin) approved in 2011, were combined and the combination drug product Glyxambi was approved in 2015. Another combination of empagliflozin, with metformin – Synjardy – was also approved in August last year. Lesser known companies also got combination drugs approved. UK-based development company Vernalis got approval for its cold-cough treatment, Tuzistra XR – an extended release suspension of codeine polistirex and chlorpheniramine polistirex. Similarly, US-based biopharmaceutical startup, Spriaso LLC, also working in the cold and cough therapeutic area, got an extended release tablet containing codeine phosphate and chlorpheniramine maleate approved. Symplmed, a company which is developing various forms of Perindopril, got approval for Prestalia (a combination of perindopril arginine and amlodipine besylate) for the treatment of hypertension. Our view Each year, the FDA approves several pharmaceutical drugs in order to improve patient care; and often versions of these drugs are marketed and distributed across the globe. PharmaCompass’ list of drugs approved in 2015 is now available – just email us for your copy. Accelerate your drug development PharmaCompass has also launched the Drug Development Assistance tool on its platform. Simply search for the drug or the active ingredient of your interest, click on the Drug Development icon on the left menu bar and you can see the inactive ingredients used to formulate the various drug products approved in the United States.

Impressions: 5419

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#PharmaFlow by PHARMACOMPASS

14 Jan 2016

Find PharmaFlow Article for Rolapitant hydrochloride

Rolapitant Hydrochloride

Rolapitant hydrochloride

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

3 API Suppliers

1 USDMF

2 NDC API

3 Listed Suppliers

INTERMEDIATES

7 Suppliers

DOSSIERs // Finished Dosage Formulations

2 Dossiers

2 FDA Orange Book

DRUG PRODUCT COMPOSITION

TABLET;ORAL - EQ 90MG BASE

EMULSION;INTRAVENOUS - EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

RELATED EXCIPIENT COMPANIES

Suppliers

21 BASF

21 Kerry

16 Roquette

11 Sigachi Industries

11 Gangwal Chemicals

10 Microlex e.U

8 Gangwal Healthcare

8 Actylis

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

7 Seppic

5 DFE Pharma

5 Corel Pharma Chem

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

4 SPI Pharma

3 Ingredion Pharma Solutions

3 Prachin Chemical

3 Ideal Cures Pvt Ltd

3 Nanjing Well Pharmaceutical

3 Vasa Pharmachem

2 Pharmatrans-Sanaq

2 Nomisma Healthcare

2 Seqens

2 Jai Radhe Sales

1 Nanjing Bold Chemical

1 Boai NKY Pharmaceuticals Ltd

1 DKSH

1 Aeon Procare

1 Finar

1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders

26 Direct Compression

24 Solubilizers

22 Disintegrants & Superdisintegrants

19 Coating Systems & Additives

17 Controlled & Modified Release

17 Thickeners and Stabilizers

17 Granulation

15 Parenteral

13 Lubricants & Glidants

12 Topical

11 Co-Processed Excipients

6 Film Formers & Plasticizers

6 Taste Masking

5 Emulsifying Agents

5 Chewable & Orodispersible Aids

3 Rheology Modifiers

3 API Stability Enhancers

2 Surfactant & Foaming Agents

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions

MARKET PLACE

5 APIs

PATENTS

13 US Patents

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow

11 News

API SUPPLIERS

API REF. PRICE (USD / KG)