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Last Updated: July 17, 2024

PAR PHARM Company Profile


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

PAR PHARM has ninety-nine approved drugs.

There is one US patent protecting PAR PHARM drugs. There are thirteen tentative approvals on PAR PHARM drugs.

There are nine patent family members on PAR PHARM drugs in eight countries and forty-nine supplementary protection certificates in fourteen countries.

Summary for PAR PHARM

Drugs and US Patents for PAR PHARM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm SUMYCIN tetracycline hydrochloride SUSPENSION;ORAL 060400-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up
Par Pharm Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 207199-003 Mar 14, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up
Par Pharm CLOZAPINE clozapine TABLET;ORAL 075162-001 Apr 26, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up
Par Pharm Inc AMBRISENTAN ambrisentan TABLET;ORAL 209509-002 Apr 10, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up
Par Pharm HALOPERIDOL haloperidol TABLET;ORAL 071328-001 Jul 20, 1987 DISCN No No ⤷  Sign Up ⤷  Sign Up
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-005 Oct 30, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up
Par Pharm OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200792-004 Oct 24, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for PAR PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Nasal Spray 500 mcg/spray ➤ Subscribe 2017-04-28

Supplementary Protection Certificates for PAR PHARM Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 SPC/GB97/023 United Kingdom ⤷  Sign Up PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
2101777 93081 Luxembourg ⤷  Sign Up PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2330892 CR 2016 00062 Denmark ⤷  Sign Up PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892 122016000107 Germany ⤷  Sign Up PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 93351 Luxembourg ⤷  Sign Up PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062
0454511 SPC/GB99/008 United Kingdom ⤷  Sign Up PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0502314 SPC/GB02/037 United Kingdom ⤷  Sign Up PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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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.