Weekly summary September 23 - 27, 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

Launch date	DRUG	Marketer	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
17 Sep. 2019	Daptomycin injections	Cipla	Cubicin (Cubist)	$606 Mn	Link

 

NEW PARAGRAPH IV FILING

Drug	Strengths	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)	Number Of ANDAs submitted
Sacubitril and Valsartan tablets	24 mg/26 mg, 49 mg/51 mg 97 mg/103 mg	Entresto (Novartis)	8 July 2019	NCE-1	20
Dolutegravir Sodium and Lamivudine tablets#	50 mg/300 mg	Dovato (ViiV)	30 July 2019	Open first to file	1
Cabozantinib tablets	20 mg, 40 mg and 60 mg	Cabometyx (Exeltis)	16 Aug. 2019	Open first to file	1
Levothyroxine Sodium capsules	88 mcg, 100 mcg and 125 mcg	Tirosint (IBSA)	1 Aug. 2019	Open first to file	1
Epinephrine injection	30 mg/30 ml	Adrenalin (Par)	20 Aug. 2018	Open first to file	1
Brexpiprazole tablets	0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg	Rexulti (Otsuka)	10 July 2019	NCE-1

FDA’s updated list on Paragraph four filings is available here.

Dolutegravir/Lamivudine combination tablet was approved by FDA in April 2019.

505(b)(2) IN PIPELINE

Rizatriptan orally disintegrating film (IntelGenX): IntelGenx announces resubmission of Rizaport^® 505(b)(2) NDA.

-      Back in April 2019, the Company announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding the NDA for RIZAPORT^® VersaFilm^® accepted by the Agency on November 20, 2018.

-      The issues cited in the April CRL relate to the Chemistry, Manufacturing and Controls section of the application. The FDA requested additional information, but no new bioequivalence study.

-      The resubmitted NDA is subject to the FDA’s acceptance review, the results of which are expected within 30 days.

-      Press release: Link

 

Weekly summary: 16 Sep. - 20 Sep.2019

NEWS FROM USA

505(b)(2) APPROVALS

Approval Date	Product Name	NDA Sponsor	Comment
18 Sep 2019	Baclofen oral solution (Ozobax) 5 mg/5 ml	Metacel Pharma	Ozobax is the first oral solution formulation of Baclofen approved in the US. Currently Baclofen is available as oral tablets and injectable formulations in the US. Indications and dosing patterns of Ozobax are similar to that of tablets. Comparison between Baclofen oral solution and Baclofen tablets is available here. Prescribing Information| FDA Approval letter
19 Sep 2019	Potassium phosphates injections	CMP development LLC	It is a phosphorus replacement product indicated as a source of Phosphorus. Injectable solution supplied in glass vial. The solution is administered after dilution or admixing by the intravenous route. Prescribing Information| FDA Approval letter

 

OTHER NDA APPROVAL

Approval Date	Product Name	NDA Sponsor	Comment
20 Sep. 2019	Semaglutide oral tablets (Rybelsus)	Novo Nordisk	Rybelsus is the first oral glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States. Injectable Semaglutide was approved by FDA in Dec. 2017. Previously approved other GLP-1 agonist Liraglutide is available only in the injectable form. FDA Press announcement | Prescribing Information

 

 

NEW GENERICS LAUNCHES IN US

LAUNCH DATE	DRUG	Marketer	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
17 Sep. 2019	Fulvestrant injections	Mylan	Faslodex (AstraZeneca)	$550 Mn	Link
16 Sep. 2019	Lansoprazole delayed release capsules 15 mg	Dr. Reddy’s Laboratories	Prevacid 24HR (Takeda)	$57 Mn	Link

 

NEW STRENGTH APPROVALS

Write us on pharmacaption@gmail.com, if you want to know new strengths approved in existing NDAs during August 2019.

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

New Product specific guidances Sep. 2019

In the mid September 2019, USFDA published 34 new product-specific guidances for generic development. Check the complete list below:

FDA also revised guidances for 19 products. See here

Weekly summary: 9 Sep. - 13 Sep. 2019

 

NEWS FROM USA

505(b)(2) APPROVAL

Approval Date	Product Name	NDA Sponsor	Comment
10 Sep 2019	Glucagon Injectable – Prefilled syringes and autoinjector (Gvoke)	Xeris Pharma	Gvoke is the first ready-to-use Glucacgon injectable formulation approved in the US. Currently available two other emergency Glucagon products (From Lilly and Novo Nordisk) are lyophilized formulations that require reconstitution with diluent. Another Glucagon product from Fresenius is also lyophilized powder. Fresenius’ Glucagon was marketed only as diagnostic aid. Recently on 9th September, Fresenius received approval to market its Glucagon product for the treatment of hypoglycaemia. Comparison between Glucagon by Lilly, Novo Nordisk and Xeris is available here. Xeris Pharma Press release Prescribing Information| FDA Approval letter

 

NEW GENERICS LAUNCHES IN US

LAUNCH DATE	DRUG	Marketer	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
11 Sep 2019	Fosaprepitant injection	Dr Reddy	Emend (Merck)	$279 Million	Link
09 Sep 2019	Phenylephrine Injections (5 ml and 10 ml)	Hikma Pharma	N/A	$28 Million	Link
05 Sep 2019	Fosaprepitant injection	Apotex	Emend (Merck)	$279 Million	Link
05 Sep 2019	Bupropion Hydrochloride ER Tablets	Dr Reddy	Zyban (GSK)	$5.4 Million	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
Nicotine Polacrilex oral lozenges	PLD acquisitions	Nicorette (Glaxo)	1 Oct. 2019

                         

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

Drug	Applicant	Corresponding RLD	CGT exclusivity expiration date
Aminocaproic acid oral syrup	Amneal	Amicar (Clover)	26 Feb. 2020

 

Complete List of products with granted CGT exclusivity till date is available here.

NEW STRENGTH APPROVALS

Write us on pharmacaption@gmail.com, if you want to know new strengths approved in existing NDAs during August 2019.

OTHER NEWS FROM US

FDA issued alert statement on NDMA (probable carcinogen) found in the samples of Ranitidine - Link

 

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

Monthly summary August 2019

505(B)2 APPROVALS

Approval Date	Product Name	NDA Sponsor	Comment
20 Aug. 2019	Fulvestrant IM injections	Teva	This is second 505(b)2 for fulvestrant injections. Previously Fresenius has also received 505(b)2 approval for Fulvestrant.   Comparison between Faslodex, Fresenius’s 505(b)2 and Teva’s 505 (b)2 is available here.   Prescribing Information| FDA Approval letter
29 Aug. 2019	Metformin ER powder for oral suspension (Riomet ER)	Sun pharma	Riomet ER is the first extended release oral suspension of Metformin.   Currently Metformin is available in oral solution dosage form (Riomet).   More information - available here.   Prescribing Information| FDA Approval letter

 

 

FIRST TIME ANDA APPROVALS OF OFF-PATENT OFF-EXCLUSIVITY PRODUCTS*

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD
12 Aug. 2019	Halcinonide 0.1% topical cream#	Mylan	Halog (Sun)
19 Aug. 2019	Triamterene oral capsules#	Agnitio	Dyrenium (Concordia)
23 Aug.  2019	Aminocaproic acid oral syrup#	Amneal	Amicar (Clover)
26 Aug. 2019	Nitisinone oral capsules#	Novitium	Orfadin (Swedish orphan)
21 Aug. 2019	Posaconazole delayed release tablets*	Sinotherapeutics	Noxafil (Merck)

^#These products might have received CGT (Competitive Generic Therapy) designation.

*The only currently listed patent of Posaconazole delayed release tablets was expired in July 2019.

 Lannett has also entered into distribution agreement with Sinotherapeutics for Posaconazole delayed release tablets (See here). Lannett is going to launch this product in the near future (Brand sales $325 Mn, as quoted in the press release).