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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Medtronic
McKinsey
Cerilliant
Healthtrust
Mallinckrodt
Novartis
Queensland Health
UBS

Generated: October 18, 2017

DrugPatentWatch Database Preview

Par Sterile Products Company Profile

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What is the competitive landscape for PAR STERILE PRODUCTS, and what generic alternatives to PAR STERILE PRODUCTS drugs are available?

PAR STERILE PRODUCTS has twenty-eight approved drugs.

There are seven US patents protecting PAR STERILE PRODUCTS drugs and there have been three Paragraph IV challenges on PAR STERILE PRODUCTS drugs in the past three years. There is one tentative approval on PAR STERILE PRODUCTS drugs.

There are three patent family members on PAR STERILE PRODUCTS drugs in three countries and thirty-eight supplementary protection certificates in eleven countries.

Summary for Applicant: Par Sterile Products

International Patents:3
US Patents:7
Tradenames:26
Ingredients:26
NDAs:28
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Sterile Products
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride
INJECTABLE;INJECTION204773-001Aug 22, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Par Sterile Products
KETALAR
ketamine hydrochloride
INJECTABLE;INJECTION016812-001Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
Par Sterile Products
NEOSTIGMINE METHYLSULFATE
neostigmine methylsulfate
SOLUTION;INTRAVENOUS208405-002Apr 26, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Par Sterile Products
BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride
INJECTABLE;INJECTION206586-001Jul 28, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Par Sterile Products
DANTRIUM
dantrolene sodium
INJECTABLE;INJECTION018264-001Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
Par Sterile Products
MEROPENEM
meropenem
INJECTABLE;INJECTION204139-002Jun 9, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Par Sterile Products
ETHACRYNATE SODIUM
ethacrynate sodium
INJECTABLE;INJECTION205473-001Jul 29, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Par Sterile Products
ADRENALIN
epinephrine
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS204640-001Dec 18, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Par Sterile Products
VASOSTRICT
vasopressin
SOLUTION;IV (INFUSION)204485-002Dec 17, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Par Sterile Products
VASOSTRICT
vasopressin
SOLUTION;IV (INFUSION)204485-001Apr 17, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Par Sterile Products

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Sterile Products
DANTRIUM
dantrolene sodium
CAPSULE;ORAL017443-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Par Sterile Products
DANTRIUM
dantrolene sodium
CAPSULE;ORAL017443-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Par Sterile Products
DANTRIUM
dantrolene sodium
INJECTABLE;INJECTION018264-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Par Sterile Products
DANTRIUM
dantrolene sodium
CAPSULE;ORAL017443-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Paragraph IV activity for PAR STERILE PRODUCTS drugs

Drugname Dosage Strength Tradename Submissiondate
epinephrine
Injection1 mg/mL ampules
ADRENALIN
3/9/2016
levothyroxine sodium
for Injection200 mcg/vial
LEVOTHYROXINE SODIUM
5/1/2015
levothyroxine sodium
for Injection100 mcg/vial and 500 mcg/vial
LEVOTHYROXINE SODIUM
4/14/2015
argatroban in sodium chloride
Injection1 mg/mL, 50 mL vials
ARGATROBAN
12/16/2011
argatroban
Injection100 mg/mL, 2.5 mL vials
ARGATROBAN
9/24/2007

International Patent Family for Par Sterile Products Drugs

Country Document Number Estimated Expiration
Canada2978464► Subscribe
World Intellectual Property Organization (WIPO)2016149028► Subscribe
Australia2016233682► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Par Sterile Products Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
C0004Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
C0008Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2009004,C0770388Lithuania► SubscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
00071Netherlands► SubscribePRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Baxter
Harvard Business School
Covington
US Army
McKinsey
Cerilliant
Farmers Insurance
Chubb
Citi

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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