MYLAN SPECIALITY LP Company Profile
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What is the competitive landscape for MYLAN SPECIALITY LP, and what generic alternatives to MYLAN SPECIALITY LP drugs are available?
MYLAN SPECIALITY LP has thirty-one approved drugs.
There are twenty US patents protecting MYLAN SPECIALITY LP drugs.
There are one hundred and eighty-one patent family members on MYLAN SPECIALITY LP drugs in thirty-seven countries and seventy supplementary protection certificates in seventeen countries.
Summary for MYLAN SPECIALITY LP
| International Patents: | 181 |
| US Patents: | 20 |
| Tradenames: | 35 |
| Ingredients: | 26 |
| NDAs: | 31 |
Drugs and US Patents for MYLAN SPECIALITY LP
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | COLYTE | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | FOR SOLUTION;ORAL | 018983-004 | Oct 26, 1984 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-002 | Nov 19, 1996 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan Speciality Lp | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189-003 | Jul 29, 1993 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Speciality Lp | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | AB | RX | Yes | Yes | 8,870,827 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Mylan Speciality Lp | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | AB | RX | Yes | Yes | 9,586,010 | ⤷ Try a Trial | Y | ⤷ Try a 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 MYLAN SPECIALITY LP
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | DEMADEX | torsemide | TABLET;ORAL | 020136-003 | Aug 23, 1993 | 4,018,929 | ⤷ Try a Trial |
| Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | 4,421,762 | ⤷ Try a Trial |
| Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | 4,515,805 | ⤷ Try a Trial |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-003 | Nov 19, 1996 | 5,242,391 | ⤷ Try a Trial |
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | 4,657,900 | ⤷ Try a Trial |
| Mylan Speciality Lp | DEMADEX | torsemide | TABLET;ORAL | 020136-002 | Aug 23, 1993 | RE30633 | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for MYLAN SPECIALITY LP drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
| ➤ Subscribe | Ophthalmic Solution | 0.05% | ➤ Subscribe | 2006-12-13 |
| ➤ Subscribe | Inhalation Solution | 300 mg/5 mL | ➤ Subscribe | 2009-06-29 |
| ➤ Subscribe | Nasal Spray | 137 mcg/50 mcg per spray | ➤ Subscribe | 2014-06-13 |
| ➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
| ➤ Subscribe | Inhalation Solution | 0.021% and 0.042% | ➤ Subscribe | 2005-10-19 |
| ➤ Subscribe | Nasal Spray | 205.5 mcg/spray | ➤ Subscribe | 2011-12-15 |
| ➤ Subscribe | Sublingual Tablets | 5 mg and 10 mg | ➤ Subscribe | 2010-04-29 |
International Patents for MYLAN SPECIALITY LP Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4542090 | ⤷ Try a Trial |
| Australia | 2005258078 | ⤷ Try a Trial |
| European Patent Office | 2179759 | ⤷ Try a Trial |
| South Korea | 20070104884 | ⤷ Try a Trial |
| Mexico | 2007006233 | ⤷ Try a Trial |
| Portugal | 2072051 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MYLAN SPECIALITY LP Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1519731 | CA 2013 00023 | Denmark | ⤷ Try a Trial | PRODUCT NAME: AZELASTIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG EN FARMACEUTISK ACCEPTABEL ESTER AF FLUTICASON, HERUNDER AZELASTIN HYDROCHLORID OG FLUTICASON PROPIONAT; NAT. REG. NO/DATE: MT49785 20130219; FIRST REG. NO/DATE: SK 24/0055/13-S 20130215 |
| 1280520 | C01280520/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012 |
| 1519731 | C01519731/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013 |
| 2782584 | 301153 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406 |
| 0770388 | PA2009004,C0770388 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103 |
| 1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| >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.
Here is a list of applicants with similar names.
