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Last Updated: July 12, 2020

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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 thirty approved drugs.

There are seventeen US patents protecting PAR STERILE PRODUCTS drugs. There is one tentative approval on PAR STERILE PRODUCTS drugs.

There are seven patent family members on PAR STERILE PRODUCTS drugs in seven countries and forty-five supplementary protection certificates in thirteen countries.

Summary for Par Sterile Products
International Patents:7
US Patents:17
Tradenames:28
Ingredients:28
NDAs:30
Patent Litigation for Par Sterile Products: See patent lawsuits for Par Sterile Products

Drugs and US Patents for Par Sterile Products

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 CAPSULE;ORAL 017443-003 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   Start Trial
Par Sterile Products TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 209382-004 Sep 24, 2019 AP RX No No   Start Trial   Start Trial
Par Sterile Products SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 077871-001 Jul 9, 2009 DISCN No No   Start Trial   Start Trial
Par Sterile Products NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 208405-001 Apr 26, 2017 AP RX No No   Start Trial   Start Trial
Par Sterile Products AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076394-001 Apr 25, 2003 DISCN No No   Start Trial   Start Trial
Par Sterile Products CORPHEDRA ephedrine sulfate SOLUTION;INTRAVENOUS 208943-001 Jan 27, 2017 AP RX No No   Start Trial   Start Trial
Par Sterile Products KETALAR ketamine hydrochloride INJECTABLE;INJECTION 016812-002 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Par Sterile Products

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-001 Approved Prior to Jan 1, 1982 3,415,821   Start Trial
Par Sterile Products DANTRIUM dantrolene sodium INJECTABLE;INJECTION 018264-001 Approved Prior to Jan 1, 1982 3,415,821   Start Trial
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-002 Approved Prior to Jan 1, 1982 3,415,821   Start Trial
Par Sterile Products DANTRIUM dantrolene sodium CAPSULE;ORAL 017443-003 Approved Prior to Jan 1, 1982 3,415,821   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for PAR STERILE PRODUCTS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Injection 1 mg/mL ampules ➤ Subscribe 2016-03-09
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 20 units/mL, 1 mL ➤ Subscribe 2018-03-23

Supplementary Protection Certificates for Par Sterile Products Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0136011 2000C/027 Belgium   Start Trial PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 132016000025143 Italy   Start Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
0281713 96C0031 Belgium   Start Trial PRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103
1534313 2015/071 Ireland   Start Trial PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
0770388 9/2009 Austria   Start Trial PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Harvard Business School
Express Scripts
McKesson
AstraZeneca

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 verification 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.