MolPort-001-792-505

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

10 API Suppliers, 5 USDMF, 1 CEP/COS, 3 EU WC, 2 KDMF, 2 NDC API, 6 Listed Suppliers

DEVELOPMENTS

4 Drug(s) in Development

4 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports

DOSSIERs // Finished Dosage Formulations

31 Dossiers, 9 FDA Orange Book, 11 Europe, 4 Canada, 6 Australia, 1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

Suppliers, 9 Roquette, 8 Sigachi Industries, 7 Microlex e.U, 6 Gangwal Healthcare, 5 Gangwal Chemicals, 4 Kerry, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Actylis, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Vasa Pharmachem, 2 Prachin Chemical, 2 DFE Pharma, 1 SPI Pharma, 1 Pharmatrans-Sanaq, 1 Rochem International Inc, 1 Pharm-RX Chemical, 1 Bioplus Life Sciences, 1 Nanjing Well Pharmaceutical, 1 Ideal Cures Pvt Ltd

EXCIPIENTS BY APPLICATIONS

19 Fillers, Diluents & Binders, 12 Lubricants & Glidants, 10 Direct Compression, 10 Thickeners and Stabilizers, 6 Co-Processed Excipients, 6 Coating Systems & Additives, 6 Disintegrants & Superdisintegrants, 5 Granulation, 5 Controlled & Modified Release, 5 Taste Masking, 4 Parenteral, 4 Film Formers & Plasticizers, 2 Emulsifying Agents, 2 Chewable & Orodispersible Aids, 1 API Stability Enhancers, 1 Topical, 1 Rheology Modifiers

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 6 Finished Drug Prices

MARKET PLACE

4 APIs, 1 DOSSIERS // FDF

PATENTS

8 US Patents, 20 US Exclusivities

DIGITAL CONTENT

3 Data Compilations & Company Tracker #PharmaFlow, 11 News

Blog

Full Screen View

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

Excel Download

#PharmaFlow by PHARMACOMPASS

14 Jan 2016

Litigation free, first generic opportunities!

Wouldn’t it just be wonderful if there were opportunities to become the first generic on the market and not have to deal with patent litigation? Using the PharmaCompass database, we ran a check for products which are currently on market, without generic competition, however have no patents listed in the FDA orange book. FDA is required by law to publish approved drug products and this publication is commonly called the Orange Book. While this may sound surprising, since almost all brand-name innovator drugs have patents listed in the Orange Book, we did find some multi-million dollar products without any patent listings. The benefit of no patent listings No patent listings on the FDA orange book prevent the opportunity for the brand manufacturer to use a legal provision that delays the launch of a generic version of the product by up to 30 months. Lowered litigation costs, increased probability of an early entry to market combined with a higher share of a multi-million dollar market are all the elements of a dream product launch. The opportunities certainly seem too good to be true and our analysis came up with an interesting list of products which we have shared below. Lundbeck’s Sabril, a perfect example With almost $115 million in sales which grew at 35% in 2014, Lundbeck’s Sabril (Vigabatrin) had its non-patent, market exclusivity granted, by the FDA, to a new chemical entity expire last year. The product is still protected by some other marketing exclusities granted for new patient populations (expiry 2016) and pediatric patients (expiry 2017), Sabril presents a perfect example where generics can anticipate windfall profits. However, some generic companies are already started targeting the Sabril (Vigabatrin) opportunity based on our review of the export price data on PharmaCompass. Lundbeck’s Onfi & Northera Interestingly Lundbeck has two other products, Onfi (Clobazam) and Northera (Droxidopa) also on the list. The exclusivity protection of Onfi is scheduled to expire next year and generic competition will be a setback for Lundbeck as Onfi brought in almost $150 million in sales in 2014, a 61% increase over 2013. Droxidopa’s exclusivity protection runs out much longer (2019) as the product only obtained approval last year. However, Lundbeck has great hopes for this drug as it paid $658 million to buy the drug as soon as it was approved. Polidocanol’s $500 million sales potential Polidocanol, used in the treatment of spider (varicose) veins, was first approved in 2010 under the brand name Asclera. No patents were listed in the Orange Book and the market exclusivity on the product expired in March this year. In 2013, a new formulation of Polidocanol was launched by U.K. based, BTG International, and they expect to achieve sales of $500 million with the product. However, this time there are patents listed in the Orange book! Other examples Diagnostic agents, like Dotarem (Gadoterate Meglumine), Choline C-11 and Lumason (Sulfur Hexafluoride Lipid Microspheres) are also examples of products which are covered by non-patent exclusivity protections. Dotarem, already approved in 70 countries, is used in magnetic resonance imaging (MRI) of the brain, spnine and associated tissues while Lumason helps physicians see the heart clearer when the ultrasound image is hard to see. The generic launch of Apotex’s Ferriprox (Deferiprone) in 2016 will be interesting since our database shows four potential challengers who have U.S. Drug Master Files submitted for the product. However, two of these four companies (Aarti Drugs & Emcure Pharmaceuticals) are on the U.S. FDA import alert list and hence banned from supporting a generic launch. Glaxo’s Potiga (Ezogabine) is Big Pharma’s representative on our list. The drug, used to treat certain types of epilepsy, when launched was expected to have sales between $200-800 million. The current sales have however been well below expectations as the drug was found to be associated with risks of skin discoloration and eye abnormalities. Uncommon business There are some drugs on this list which are for uncommon diseases. Carglumic Acid and Miltefosine both address orphan drug populations, however, they have also made recent headlines. Carglumic acid is the most expensive drug per prescription dispensed in the United States. Miltefosine, on the other hand, got approval for tropical diseases which almost never occur in the country! Knight Therapeutics, which got awarded the approval was not really depending on the sales of the product. Along with the product approval they received a Neglected Tropical Disease Priority Review Voucher. The voucher reduces the review period of a new drug application from the standard 10 months to 6. Since blockbuster drugs make hundreds of millions of dollars in sales every month, a launch four months earlier could mean an extra few billion dollars in revenue. Hence, it wasn’t surprising when in November 2014, Gilead Sciences purchased the voucher from Knight for $125 million. The next priority review voucher was sold, two months ago, for an incredible $245 million dollars, generating a new multi-million dollar business of developing products for diseases which have almost no patients! Our View It is difficult to imagine that, with the stakes involved and the nature of the pharmaceutical business, there will be no litigation when a generic tries to take away market share from the innovator. However, a list of products with no patents in the Orange Book does give generics new opportunities to think about.

Impressions: 4983

Excel Download

#Phispers by PHARMACOMPASS

23 Jul 2015

The Next Generic Attack: Brilinta® (Ticagrelor), Xarelto® (Rivaroxaban), Tradjenta® (Linagliptin) and…

With almost 30,000 Drug Master Files (DMFs) submitted to the FDA, reviewing the filings of only the first quarter of 2015, provides an indicator on the current areas of focus of generic pharmaceutical companies. A detailed evaluation of the 241 filings for active pharmaceutical ingredients only, made us find some interesting trends worth sharing. European Blockbuster battle! Of the 241 DMFs, 21 APIs had more than one DMF filing and accounted for 25% of the total filings. Interestingly, 20 DMFs were for only three APIs: AstraZeneca’s blood thinner Brilinta® (Ticagrelor), with 2014 sales of $476 million, already had DMF filings from Dr. Reddy’s, Mylan, Polpharma and Zhejiang Hisun at the end of last year. With a maximum of 9 new filings from players like Teva, Alembic, Lek and others, AstraZeneca should brace itself for some serious generic onslaught. While the 9 filings for Ticagrelor were the most for any single compound, not far behind is Bayer’s own blood thinner: Xarelto® (Rivaroxaban). With 7 submissions, the focus of the generic companies is understandable as Rivaroxaban had sales in excess of $3 billion and year-on-year growth in excess of 70%. However, patents currently protect the product till 2020, so patience is needed before generics can access this golden opportunity. Interestingly, 4 filings for Linagliptin (Boehringer’s antidiabetic Tradjenta®) make it yet another European pharma giant lead the list of products being subjected to generic competition, and make us wonder why European blockbusters are preferred over others? Exclusive but not patented There are products, which have no patent protection, but the market is protected by FDA granted exclusivities (learn more on patents and exclusivities from the FDA website). An opportunity for generic companies to gain significant market share of a multi-hundred million dollar market, without any litigation risk or cost is something companies dream about. As the time of exclusivity expiry nears, Clobazam, Tetrabenazine, Hydroxyprogesterone Caproate, Deferiprone and Trypan Blue will all see increased generic activity as their Drug Master Files have been submitted. Fragmented Activity More than 80% of the DMF submissions were made by companies who filed only a single product. While the products varied from simple compounds like Sodium Chloride to biologics like Plasmid DNA, over 140 companies filed DMFs in the first quarter with almost 30 submitting a DMF for the first time. An expanding list of suppliers who support DMFs increases options for sourcing managers. However, a fragmented supplier base limits the industrial scale companies can achieve and raises concerns regarding how many can successfully sustain compliance standards under increased regulatory scrutiny? The Next Generic Wave Blood thinners are an opportunity few generic companies wish to pass on. Boehringer’s (Dabigatran Etexilate), Bristol-Myers Squibb’s (Apixaban) and Bayer’s (Rivaroxaban) are novel compounds in this category which had combined sales in excess of $5 billion last year. While Dagibatran saw a flurry of activity over the last two years with almost 15 DMF filings, there were no additional filings this year. On the other hand, Apixaban, which generated $774 million for Bristol-Myers Squibb in 2014, has only one DMF filing at the moment and that too was done over a year ago. The export data out of India, reviewed on PharmaCompass, for Apixaban, indicates that product development is already complete so it is just a matter of time before the filings begin. Conclusion: Product and supplier selection is a critical component of every generic company’s strategy. The PharmaCompass database is designed to assist professionals in business development, marketing and sourcing to take more informed decisions. If you would like us to share our shortlist of 241 DMFs, we will be happy to send it to you by email (click here). You can also access our compilation of the 2014 annual reports of major pharmaceutical companies to review the various products along with their revenues (click here): Table: Products with more than one DMF filing in Q1 2015 PRODUCT NAME DMF FILINGS TICAGRELOR 9 RIVAROXABAN 7 LINAGLIPTIN 4 APREPITANT 3 CINACALCET HYDROCHLORIDE 3 ATAZANAVIR SULFATE 2 ATORVASTATIN CALCIUM TRIHYDRATE 2 CLOBAZAM 2 CLOFARABINE 2 DEFERASIROX 2 DIMETHYL FUMARATE 2 EZETIMIBE 2 ICATIBANT ACETATE 2 LURASIDONE HYDROCHLORIDE 2 MELPHALAN HYDROCHLORIDE 2 OLANZAPINE 2 OLMESARTAN MEDOXOMIL USP 2 PRASUGREL HYDROCHLORIDE 2 RIVASTIGMINE USP 2 ROSUVASTATIN CALCIUM 2 SOLIFENACINE SUCCINATE 2

Impressions: 8782

Excel Download

#PharmaFlow by PHARMACOMPASS

13 May 2015

Find PharmaFlow Article for MolPort-001-792-505

MolPort-001-792-505

MolPort-001-792-505

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

10 API Suppliers

5 USDMF

1 CEP/COS

3 EU WC

2 KDMF

2 NDC API

6 Listed Suppliers

DEVELOPMENTS

4 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

DOSSIERs // Finished Dosage Formulations

31 Dossiers

9 FDA Orange Book

11 Europe

4 Canada

6 Australia

1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

Suppliers

9 Roquette

8 Sigachi Industries

7 Microlex e.U

6 Gangwal Healthcare

5 Gangwal Chemicals

4 Kerry

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Actylis

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Vasa Pharmachem

2 Prachin Chemical

2 DFE Pharma

1 SPI Pharma

1 Pharmatrans-Sanaq

1 Rochem International Inc

1 Pharm-RX Chemical

1 Bioplus Life Sciences

1 Nanjing Well Pharmaceutical

1 Ideal Cures Pvt Ltd

EXCIPIENTS BY APPLICATIONS

19 Fillers, Diluents & Binders

12 Lubricants & Glidants

10 Direct Compression

10 Thickeners and Stabilizers

6 Co-Processed Excipients

6 Coating Systems & Additives

6 Disintegrants & Superdisintegrants

5 Granulation

5 Controlled & Modified Release

5 Taste Masking

4 Parenteral

4 Film Formers & Plasticizers

2 Emulsifying Agents

2 Chewable & Orodispersible Aids

1 API Stability Enhancers

1 Topical

1 Rheology Modifiers

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions

6 Finished Drug Prices

MARKET PLACE

4 APIs

1 DOSSIERS // FDF

PATENTS

8 US Patents

20 US Exclusivities

DIGITAL CONTENT

3 Data Compilations & Company Tracker #PharmaFlow

11 News

API SUPPLIERS

API REF. PRICE (USD / KG)

INTERMEDIATES