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Last Updated: February 17, 2020

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Par Pharm Company Profile


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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 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201087-001 Jun 1, 2015 AB RX No No   Start Trial   Start Trial
Par Pharm PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 070565-001 Sep 11, 1986 DISCN No No   Start Trial   Start Trial
Par Pharm CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride TABLET;ORAL 087129-001 Approved Prior to Jan 1, 1982 AA RX No No   Start Trial   Start Trial
Par Pharm IBUPROFEN ibuprofen TABLET;ORAL 070986-001 Jul 25, 1986 DISCN No No   Start Trial   Start Trial
Par Pharm Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202842-006 Nov 30, 2016 AB RX No No   Start Trial   Start Trial
Par Pharm METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 204659-001 Jul 15, 2019 DISCN No No   Start Trial   Start Trial
Par Pharm SODIUM PHENYLBUTYRATE sodium phenylbutyrate TABLET;ORAL 204395-001 Apr 15, 2016 AB 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 Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Pharm Inc ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 4,859,692   Start Trial
Par Pharm CAPOTEN captopril TABLET;ORAL 018343-003 Approved Prior to Jan 1, 1982 5,238,924   Start Trial
Par Pharm CAPOTEN captopril TABLET;ORAL 018343-004 Jun 13, 1995 5,238,924   Start Trial
Par Pharm NASCOBAL cyanocobalamin GEL, METERED;NASAL 019722-001 Nov 5, 1996 4,724,231   Start Trial
Par Pharm CAPOTEN captopril TABLET;ORAL 018343-002 Approved Prior to Jan 1, 1982 4,105,776   Start Trial
Par Pharm CAPOTEN captopril TABLET;ORAL 018343-007 Jun 13, 1995 4,105,776   Start Trial
Par Pharm Inc ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 5,482,963   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for PAR PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 10 mg and 20 mg ➤ Subscribe 2008-02-29
➤ 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
0663916 SPC/GB10/003 United Kingdom   Start Trial PRODUCT NAME: EVEROLIMUS; REGISTERED: SE SE 18690-18695 20030718; UK EU/1/09/538/001 20090803; UK EU/1/09/538/002 20090803; UK EU/1/09/538/003 20090803; UK EU/1/09/538/004 20090803; UK EU/1/09/538/005 20090803; UK EU/1/09/538/006 20090803
3143995 34/2019 Austria   Start Trial PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538 IDF DER ENTSCHEIDUNG DER KOMMISSION C (2016) 3286 (MITTEILUNG) 20160530
0481754 91275 Luxembourg   Start Trial CERTIFICATE TITLE: ENTECAVIR ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BARACLUDE); FIRST REGISTRATION: 20060626
0663916 CA 2004 00020 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS
2269603 CA 2015 00058 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
1948158 1690020-1 Sweden   Start Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
2101777 PA2016018 Lithuania   Start Trial PRODUCT NAME: AMBRISENTANAS; REGISTRATION NO/DATE: EU/1/08/451 (001-004) 20151120
>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:

Johnson and Johnson
Colorcon
McKesson
AstraZeneca
Baxter
Dow

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