NEWS 27 June 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

LAUNCH DATE	DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
18 June 2019	Aspirin & ER Dipyridamole capsules	Lannett	Aggrenox (Boehringer)	$158 Million	Link
18 June 2019	Mesalamine suppository	Rising Pharma	Canasa (Allergan)	$263 Million	Link
22 June 2019	Phytonadione injectable emulsion	Dr. Reddy’s laboratories	Vitamin K1 (Hospira)	$46.6 Million	Link
25 June 2019	Tobramycin inhalation solution	Dr. Reddy’s laboratories	Tobi (Mylan)	$97 Million	Link
25 June 2019	Ranitidine capsules	ANI pharma	Zantac (GSK)	$40 Million	Link

 

NDA APPROVALS

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
21 June 2019	Bremelanotide Injection	Amag Pharms	Vyleesi	Link

 

GENERIC PATENT LITIGATIONS

Fingolimod (Novartis v. Accord et al): Novartis has won a U.S. federal court order preventing rival generic makers from selling versions of Gilenya in the United States, at least until a patent dispute is resolved. Affected generic players include Dr. Reddy’s, Aurobindo, Zydus, Torrent and others.

 

Read More: Link

 

Rotigotine Transdermal film (UCB v. Teva): Upper court in US affirms lower court’s decision that Teva’s generic Rotigotine infringes UCB patent expiring in 2021.

 

Read More: Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
19 June 2019	Scopolamine ER Transdermal Film	Mylan	Transderm Scop (GSK)	One (Perrigo)
19 June 2019	Bimatoprost Ophthalmic Solution	Somerset	Lumigan (Allergan)	Six
20 June 2019	Sodium Bicarbonate Injection	Exela Pharma	Sodium Bicarbonate (Abbott Lab)	Two
20 June 2019	Ganciclovir Sodium Injection	Custopharm	Cytovene (Roche Palo)	Five
21 June 2019	Dextroamphetamine Sulfate ER Capsules	Pii	Dexedrine (Impax)	Six
21 June 2019	Mesalamine Suppository	Amring	Canasa (Allergan)	Three
21 June 2019	Bromfenac Sodium Ophthalmic Solution	Alembic Pharms	Xibrom (Bausch and Lamb)	Two

 

OTHER NEWS FROM USA

FDA updates list of off-patent, off-exclusivity drugs without generic competition

 

Read more: Link

 

Full updated list of off-patent, off-exclusivity drugs without generic competition: Link

 

If you have any query/suggestion then please write us at pharmacaption@gmail.com

NEWS 19 June 2019

NEWS FROM USA

505(b)2 APPROVAL

 

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
13 June 2019	Budesonide ER capsules (6 mg and 9 mg)	Sun Pharma	Ortikos	Link

 

 

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
Erlotinib hydrochloride tablets	Mylan	Tarceva (OSI)	5 Nov. 2019	Natco

 

New CGT (competitive generic therapy) exclusivity listing in the orange book

Drug	Applicant	Corresponding RLD	CGT exclusivity expiration date
Sildenafil powder for oral suspension	Novitium	Revatio (Pfizer)	27 Nov. 2019

 

NEW PARAGRAPH IV FILING

DRUG	Dosage form	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)
Halobetasol Propionate	Lotion 0.01%	Bryhali (Bausch)	20 Mar. 2019	Open First to File#
Gabapentin Enacarbil	Extended-release Tablets	Horizant	29 April 2019	Open First to File

#NDA of Bryhali was approved by USFDA on 6 Nov. 2018. First Para IV filing was done within 4 and half months of FDA approval.

Full list of Paragraph IV Patent certifications: Link

505(b)2 IN PIPELINE

Lamotrigine oral liquid (Eton/Aucta pharma):  Eton Pharmaceuticals Announces Licensing of Lamotrigine New Drug Application.

-      Eton Pharmaceuticals, Inc has entered into an agreement with Aucta Pharmaceuticals, Inc to acquire U.S. marketing rights for ET-105.

-      Aucta pharma submitted the product’s New Drug Application (NDA) to the FDA in May 2019.

-      Lamotrigine is currently only approved in tablet formulations, and Eton believes ET-105 will fulfill a significant unmet need for pediatric patients requiring precision dosing.

-      Full Press Release: Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
12 June 2019	Paliperidone ER tablets	Inventia	Invega (Janssen)	Three
12 June 2019	Loratidine chewable tablets	Perrigo	Children’s Claritin (Bayer)	One (Sun)
12 June 2019	Vancomycin injection	Hainan polypharma	Vancocin (Baxter)	Ten
13 June 2019	Dorzolamide, Timolol ophthalmic drops	FDC	Cosopt (Oak pharma)	Seven
14 June 2019	Diltiazem ER capsules	Novast	Cardizem CD (Bausch)	Seven
14 June 2019	Omega-3 acid ethyl ester	Zydus	Lovaza (Smithkline Beecham)	Six
17 June 2019	Potassium chloride ER tablets	PII	K-tab (Abbvie)	One (Virtuvias)
18 June 2019	Diclofenac sodium 37.5 mg/ml	Mylan	Dyloject (javelin)	None

 

If you have any query/suggestion then please write us at pharmacaption@gmail.com

NEWS 13 JUNE 2019

NEWS FROM USA

505(b)2 IN PIPELINE

Naloxone Pre-Filled Single Dose Syringe (Adamis Pharma):  USFDA acknowledged the receipt of Adamis Pharma’s amendment to its previously submitted NDA of Naloxone Pre-Filled Single Dose Syringe.

-      The amendment removed EVZIO^® as a Reference Listed Drug (RLD) and withdrew the associated Paragraph IV certification.

-      Adamis said that Narcan injectable (NDA 016636) now remains as the sole RLD for its (b)2 NDA and, because there are no Orange Book listed patents for NDA 016636, no patent certification is required.

-      With this change, Adamis opined that the amended NDA will not be subject to a 30-month stay and that the FDA will be free to issue an approval as soon as the agency completes a satisfactory review of the Adamis naloxone NDA.  

-      Full Press Release: Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
04 June 2019	Ranolazine ER Tablets	Sciegen Pharms	Ranexa (Gilead)	Five
05 June 2019	Esomeprazole Magnesium DR Capsules	Amneal Pharms	Nexium 24hr (Astrazeneca)	Three
05 June 2019	Carbidopa; Levodopa ER Tablets	Alembic Pharms	Sinemet CR (Merck Sharp)	Five
06 June 2019	Desmopressin Acetate Tablets	Novast Labs	Ddavp (Ferring)	Seven
07 June 2019	Dexamethasone Sodium Phosphate Injection	Aurobindo Pharma	Hexadrol (Aspen)	Eight
10 June 2019	Niacin ER Tablets	Yichang Humanwell	Niaspan (Abbvie)	Seven
12 June 2019	Mesalamine Rectal Suppository	Sandoz	Canasa (Allergan)	Two

 

TENTATIVE ANDA APPROVALS

Approval Date	Drug	Company
03 June 2019	Erlotinib	Apotex
07 June 2019	Tofacitinib	Breckenridge

 

GENERIC PATENT LITIGATIONS

Mifepristone tablets 300 mg - Korlym (Sun Pharma): Corcept has received a Para IV Notice Letter advising that Sun Pharma submitted an ANDA to the USFDA seeking authorization from the FDA to manufacture, use or sell a generic version of KORLYM^® Mifepristone Tablets, 300 mg in the US.

-      Full Press Release: Link

 

USFDA INSPECTIONS

Cipla (Kurkumbh manufacturing facility): Cipla provided update on USFDA inspection at company’s Kurkumbh manufacturing facility

-      Full Press Release: Link

 

OTHER NEWS FROM USA

Amifampridine (Catalyst pharma): Catalyst Pharma (NDA holder of Firdapse) sues FDA over approval of cheaper rival drug (Ruzurgi).

-      The lawsuit alleges that the approval of Ruzurgi, a rival drug from privately held Jacobus Pharmaceutical Co, in May violated provisions of FDA regulations and Catalyst’s rights to orphan drug exclusivity for its drug, Firdapse.

-      Both drugs are approved to treat Lambert-Eaton myasthenic syndrome, but Firdapse was approved for adults, while Jacobus’ drug was for children. But Catalyst suspects that the unexpected approval of Ruzurgi potentially enables adults to use it off-label, which would likely erode Firdapse’s market share.

-      Firdapse treatment is priced at at $375,000 a year, while Jacobus’ treatment is priced at less than half that cost, at about $175,200 annually.

-       Full Press Release: Link

 

If you have any query/suggestion then please write us at pharmacaption@gmail.com