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Generated: August 17, 2017
What is the competitive landscape for KING PHARMS, and when can generic versions of KING PHARMS drugs launch?
KING PHARMS has twenty-seven approved drugs.| Patents: | 7 |
| Tradenames: | 25 |
| Ingredients: | 23 |
| NDAs: | 27 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-002 | May 25, 2001 | AB1,AB3 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-005 | May 25, 2001 | AB1,AB3 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
King Pharms Llc | AVINZA | morphine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021260-002 | Mar 20, 2002 | DISCN | No | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
King Pharms Llc | BICILLIN L-A | penicillin g benzathine | INJECTABLE;INJECTION | 050141-001 | Approved Prior to Jan 1, 1982 | BC | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
King Pharms Llc | CORZIDE | bendroflumethiazide; nadolol | TABLET;ORAL | 018647-001 | May 25, 1983 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
King Pharms Llc | INTAL | cromolyn sodium | SOLUTION;INHALATION | 018596-001 | May 28, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
King Pharms | ALTACE | ramipril | CAPSULE;ORAL | 019901-002 | Jan 28, 1991 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
King Pharms Llc | INTAL | cromolyn sodium | AEROSOL, METERED;INHALATION | 018887-001 | Dec 5, 1985 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
King Pharms Llc | CORZIDE | bendroflumethiazide; nadolol | TABLET;ORAL | 018647-001 | May 25, 1983 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
King Pharms Llc | INTAL | cromolyn sodium | SOLUTION;INHALATION | 018596-001 | May 28, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
morphine sulfate | Extended-release Capsules | 45 mg and 75 mg | AVINZA | 7/30/2009 |
morphine sulfate | Extended-release Capsules | 30 mg, 60 mg, 90 mg and 120 mg | AVINZA | 6/4/2007 |
metaxalone | Tablets | 800 mg | SKELAXIN | 11/4/2004 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,378,434 | Metaxalone products, method of manufacture, and method of use | ► Subscribe | |||||||||||||||||||||||||||
| 6,407,128 | Method for increasing the bioavailability of metaxalone | ► Subscribe | |||||||||||||||||||||||||||
| 8,168,664 | Metaxalone products, method of manufacture, and method of use | ► Subscribe | |||||||||||||||||||||||||||
| 6,683,102 | Methods of using metaxalone in the treatment of musculoskeletal conditions | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Estonia | 200200086 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1023051 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 303800 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2002240394 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 20020770 | ► 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.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0062 | France | ► Subscribe | PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626 | ||||||||||||||||||||||||||
| C/GB03/034 | United Kingdom | ► Subscribe | PRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313 | ||||||||||||||||||||||||||
| C0001 | Belgium | ► Subscribe | PRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919 | ||||||||||||||||||||||||||
| 80030 | Netherlands | ► Subscribe | PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919 | ||||||||||||||||||||||||||
| C/GB98/047 | United Kingdom | ► Subscribe | PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825 | ||||||||||||||||||||||||||
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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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