NEWS FROM USA
NEW EXCLUSIVITY LISTINGS IN THE ORANGE BOOK
New PC (Patent Challenge) exclusivity listing in the orange book
|
Drug |
Applicant |
Corresponding RLD |
PC exclusivity expiration date |
Other TA holders |
|
Febuxostat tablets (40mg and 80 mg) |
Mylan |
Uloric (Takeda) |
Lupin, Torrent, Zydus, MSN, Prinston, Beijing SL |
New CGT (competitive generic therapy) exclusivity listing in the orange book
|
Drug |
Applicant |
Corresponding RLD |
CGT exclusivity expiration date |
|
Digoxin Oral Elixir |
Novitium |
Digoxin (Hikma) |
Complete list of the products that have received CGT exclusivity till date is available here.
NEW 505(b)(2) LAUNCHES IN THE US
|
Date |
Product Name |
NDA Sponsor |
Comment |
|
16 Oct. 2019 |
Duloxetine DR capsules (Drizalma sprinkle) |
Sun Pharma |
Previously marketed Duloxetine is available as delayed release capsule that is required to be taken as whole, while Drizalma Sprinkle® may be opened and sprinkled over applesauce; or administered via nasogastric tube.
|
|
14 Oct. 2019 |
Cyclosporine Ophthalmic Solution (Cequa) |
Sun Pharma |
CEQUA™ 0.09% for topical ophthalmic use is the first and only approved cyclosporine treatment delivered with nanomicellar (NCELL™) technology. The NCELL formulation penetrates the aqueous layer of the tear film in the eye, then the nanomicelles break up to release cyclosporine to penetrate ocular tissues. |
TENTATIVE 505(b)(2) APPROVALS
|
Approval Date |
Product Name |
NDA Sponsor |
Comment |
|
09 Oct 2019 |
Pemetrexed ready-to-dilute Injection (Pemfexy) |
Eagle Pharms |
PEMFEXY™ is a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin. Strength: 25 mg/ml |
|
11 Oct 2019 |
Diroximel Fumarate DR Capsules (Vumerity) |
Alkermes |
According to Alkermes, Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and may have the potential to offer differentiated gastrointestinal tolerability due to its chemical structure as compared to the currently marketed dimethyl fumarate, TECFIDERA.
In November 2017, Alkermes entered into an exclusive license and collaboration agreement with Biogen relating to diroximel fumarate.
|
If you want to avail patent information related to any of the above product, then write us at pharmacaption@gmail.com
505(b)(2) APPROVALS OF OCTOBER 2019
Click on summary to read more about corresponding 505(b)(2) approvals.
|
Product name |
|
|
Dexamethasone tablets (Dexcel Pharma) |
|
|
Bortezomib Injections (Dr. Reddy’s) |
|
|
Cetirizine Injections (JDP therapeutics) |
|
|
Teriparatide Injections (Pfenex) |
|
|
Asenapine Transdermal Patch (Hisamitsu) |
Other news from US
Suboxone oral film (Indivior):
Indivior intends to cease production of its authorized Suboxone generic (marketed by Sandoz) to cut losses from a change in rebating policy in the United States.
Press release: Link
NEWS FROM EUROPE
DIFFERENTIATED GENERIC APPROVALS OF UK DURING SEPTEMBER 2019
Write us at pharmacaption@gmail.com, if you want to get information related to differentiated generic approvals of United Kingdom (UK) during September 2019.
