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Serving leading biopharmaceutical companies globally:

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Colorcon
Medtronic
Johnson and Johnson
Merck
Boehringer Ingelheim

Last Updated: December 15, 2019

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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-three supplementary protection certificates in twelve 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 VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-002 Dec 17, 2016 RX Yes Yes 9,375,478   Start Trial   Start Trial
Par Sterile Products DANTRIUM dantrolene sodium INJECTABLE;INJECTION 018264-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial
Par Sterile Products VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-002 Dec 17, 2016 RX Yes Yes 9,687,526   Start Trial   Start Trial
Par Sterile Products DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-004 Approved Prior to Jan 1, 1982 AO RX Yes Yes   Start Trial   Start Trial
Par Sterile Products KETALAR ketamine hydrochloride INJECTABLE;INJECTION 016812-003 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
>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 for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 20 units/mL, 1 mL ➤ Subscribe 2018-03-23
➤ 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

Supplementary Protection Certificates for Par Sterile Products Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 08C0004 France   Start Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
0285237 95C0008 Belgium   Start Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
0770388 09C0018 France   Start Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0694547 C300071 Netherlands   Start Trial PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
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
>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:

Harvard Business School
Johnson and Johnson
Medtronic
Baxter
Express Scripts
Colorcon

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