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Serving 500+ biopharmaceutical companies globally:

Novartis
Fuji
Fish and Richardson
Queensland Health
Harvard Business School
Colorcon
Chinese Patent Office
Federal Trade Commission
Dow
Merck

Generated: August 23, 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 four 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 is one patent family member on PAR STERILE PRODUCTS drugs in one country.

Summary for Applicant: Par Sterile Products

Patents:4
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
DANTRIUM
dantrolene sodium
INJECTABLE;INJECTION018264-001Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
Par Sterile Products
VASOSTRICT
vasopressin
SOLUTION;IV (INFUSION)204485-002Dec 17, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Par Sterile Products
PITOCIN
oxytocin
INJECTABLE;INJECTION018261-003Sep 5, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Par Sterile Products
DANTRIUM
dantrolene sodium
CAPSULE;ORAL017443-002Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Par Sterile Products
PITOCIN
oxytocin
INJECTABLE;INJECTION018261-002Jul 27, 2007APRXYesNo► Subscribe► Subscribe► Subscribe
Par Sterile Products
CORPHEDRA
ephedrine sulfate
SOLUTION;IV (INFUSION)208943-001Jan 27, 2017RXNoNo► Subscribe► Subscribe► Subscribe
Par Sterile Products
COLY-MYCIN M
colistimethate sodium
INJECTABLE;INJECTION050108-002Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
Par Sterile Products
PITOCIN
oxytocin
INJECTABLE;INJECTION018261-001Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
Par Sterile Products
ADRENALIN
epinephrine
INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS204200-001Dec 7, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Par Sterile Products
LEVOTHYROXINE SODIUM
levothyroxine sodium
POWDER;INTRAVENOUS205366-001Dec 7, 2015APRXNoNo► 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
CAPSULE;ORAL017443-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Par Sterile Products
DANTRIUM
dantrolene sodium
INJECTABLE;INJECTION018264-001Approved 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
World Intellectual Property Organization (WIPO)2016149028► 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
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
C0005Belgium► SubscribePRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
C/GB09/026United Kingdom► SubscribePRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
C0023Belgium► SubscribePRODUCT NAME: MEROPENEM TRIHYDR; NAT. REGISTRATION NO/DATE: 624 IS 88 F 12 19960205; FIRST REGISTRATION: IT 028949028 19940817
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
C/GB95/030United Kingdom► SubscribePRODUCT NAME: MEROPENEM OPTIONALLY IN THE FORM OF A HYDRATE AND /OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: IT 99/1994 19940817; UK 12619/0097 19950119; UK 12619/0098 19950119; UK 12619/0099 19950119; UK 12619/0100 19950119
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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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 500+ biopharmaceutical companies globally:

Cipla
Boehringer Ingelheim
Cantor Fitzgerald
Colorcon
US Army
Mallinckrodt
Fish and Richardson
Merck
Federal Trade Commission
Chinese Patent Office

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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