Approval time for CGT designated ANDAs: Review

Till date, USFDA has approved 18 ANDAs with CGT exclusivity.

We have reviewed approval details of 17 out of these 18 ANDAs. Based on that, we have come across the following facts:

·         The average approval time for these 17 ANDAs was approximately 11 months from the date of submission of ANDAs. 5 out of these 17 approved ANDAs had received CRL in the first review cycle. If we remove these 5 outliers from the average then the average approval time for the remaining 12 ANDAs was approximately 9 months.

·         The shortest approval time was 233 days (less than 8 months) while the longest approval time was 626 days (approximately 20 months).

·         More than 75% of these 17 ANDAs were approved by FDA within 12 months of the ANDA submission.

·         The average approval time for topical products was close to 9 months while the average approval time for solid oral products was slightly less than 12 months.

Want complete excel compilation of CGT designated ANDAs with the Approval time then write us at pharmacaption@gmail.com

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

NCE-1 filing: scenario year-to-date

Year-to-date, the FDA has reported paragraph IV ANDA submissions against 11 brand products having NCE-1 dates in 2019. Most of them are the oral solid products with just two exceptions, one being injectable while the other being oral liquid.

Sacubitril/Valsartan witnessed the highest number of ANDA filers (19) while Patiromer and Cangrelor witnessed the lowest number of ANDA filers (two against each of them).

See below the complete list of New Chemical Entities (NCEs) that witnessed Paragraph IV ANDA submission in 2019.

Active Ingredient	Dosage form	Brand Name	No. Of ANDA submitted
Sacubitril and Valsartan	Oral Tablets	Entresto	19
Trifluridine and Tipiracil	Oral Tablets	Lonsurf	4
Brexpiprazole	Oral Tablets	Rexulti	18
Cariprazine	Oral Capsules	Vraylar	3
Eluxadoline	Oral Tablets	Viberzi	6
Ivabradine	Oral Tablets	Corlanor	6
Patiromer	Oral Suspension	Veltassa	2
Cangrelor	Injectable	Kengreal	2
Palbociclib	Oral Capsules	Ibrance	>10*
Lenvatinib	Oral Capsules	Lenvima	N/A
Edoxaban	Oral Tablets	Savaysa	N/A

 

*Based on the number of lawsuits of Patent Infringement

Which, do you consider is the better business case for a generic company?

1) The brand product with good sales number but have 20 first filers, or

2) The brand product with moderate to low sales numbers and has only 2-3 first filers.

If you want information on open First-To-File opportunities grabbed by the generic filers in 2019, then write us at pharmacaption@gmail.com.

 

 

 

 

 

505(b)(2) and Generic Updates

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)	28 Dec. 2019	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)	1 Apr. 2020

 

 

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.   Prescribing Information|FDA Approval letter|Press release
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. Prescribing Information|FDA Approval letter|Press release

 

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 FDA TA letter
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.   FDA TA letter

 

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)	Summary
Bortezomib Injections (Dr. Reddy’s)	Summary
Cetirizine Injections (JDP therapeutics)	Summary
Teriparatide Injections (Pfenex)	Summary
Asenapine Transdermal Patch (Hisamitsu)	Summary

 

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.

 

 

 

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