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Last Updated: March 29, 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 twenty-nine approved drugs.

There are nine 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-four supplementary protection certificates in thirteen countries.

Summary for Par Sterile Products
International Patents:7
US Patents:9
Tradenames:27
Ingredients:27
NDAs:29
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 DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-002 Approved Prior to Jan 1, 1982 RX Yes Yes   Start Trial   Start Trial
Par Sterile Products TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 209382-002 Sep 24, 2019 AP RX No No   Start Trial   Start Trial
Par Sterile Products ETOMIDATE etomidate INJECTABLE;INJECTION 091297-001 Jun 20, 2012 DISCN No No   Start Trial   Start Trial
Par Sterile Products PITOCIN oxytocin INJECTABLE;INJECTION 018261-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial
Par Sterile Products BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride INJECTABLE;INJECTION 206586-001 Jul 28, 2015 AP RX No No   Start Trial   Start Trial
Par Sterile Products VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-001 Apr 17, 2014 RX Yes Yes 9,744,209   Start Trial   Start Trial
Par Sterile Products ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204640-001 Dec 18, 2013 RX Yes Yes 9,295,657   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 CAPSULE;ORAL 017443-003 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
>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
1110543 SPC/GB08/005 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
1534313 92923 Luxembourg   Start Trial PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
0770388 PA2009004 Lithuania   Start Trial PRODUCT 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
0694547 03C0003 France   Start Trial PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>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

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