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Generated: August 17, 2017
What is the competitive landscape for PAR PHARM INC, and when can generic versions of PAR PHARM INC drugs launch?
PAR PHARM INC has twenty-three approved drugs.| Patents: | 1 |
| Tradenames: | 22 |
| Ingredients: | 22 |
| NDAs: | 23 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Par Pharm Inc | MORPHINE SULFATE | morphine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 200812-003 | Nov 10, 2011 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Par Pharm Inc | BALSALAZIDE DISODIUM | balsalazide disodium | TABLET;ORAL | 206336-001 | Sep 8, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Par Pharm Inc | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090011-004 | Mar 28, 2013 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Par Pharm Inc | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 206137-003 | Oct 26, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Par Pharm Inc | ENTECAVIR | entecavir | TABLET;ORAL | 206294-001 | Nov 23, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Par Pharm Inc | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Par Pharm Inc | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Par Pharm Inc | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Par Pharm Inc | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Par Pharm Inc | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
zafirlukast | Tablets | 10 mg and 20 mg | ACCOLATE | 2/29/2008 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2006240490 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2605413 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | 2007013118 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5378788 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2008538560 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00478 | Netherlands | ► Subscribe | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007 | ||||||||||||||||||||||||||
| 2014 00048 | Denmark | ► Subscribe | PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724 | ||||||||||||||||||||||||||
| 00445 | Netherlands | ► Subscribe | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 | ||||||||||||||||||||||||||
| 00528 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 | ||||||||||||||||||||||||||
| C0043 | France | ► Subscribe | PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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