MYLAN SPECIALITY LP Company Profile
✉ Email this page to a colleague
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 | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | 11,484,671 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Mylan Speciality Lp | COLYTE | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | FOR SOLUTION;ORAL | 018983-005 | Oct 26, 1984 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan Speciality Lp | EPIFOAM | hydrocortisone acetate; pramoxine hydrochloride | AEROSOL, METERED;TOPICAL | 086457-001 | Approved Prior to Jan 1, 1982 | BX | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Speciality Lp | DEMADEX | torsemide | TABLET;ORAL | 020136-002 | Aug 23, 1993 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan Speciality Lp | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | AB | RX | Yes | Yes | 7,794,432 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Mylan Speciality Lp | ACCUNEB | albuterol sulfate | SOLUTION;INHALATION | 020949-002 | Apr 30, 2001 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan Speciality Lp | EPI E Z PEN JR | epinephrine | INJECTABLE;INTRAMUSCULAR | 019430-004 | Aug 3, 1995 | DISCN | No | No | ⤷ Try a Trial | ⤷ 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 | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 8,349,294 | ⤷ Try a Trial |
| Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | 4,657,900 | ⤷ Try a Trial |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-001 | Nov 19, 1996 | 5,886,039 | ⤷ Try a Trial |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-004 | Nov 19, 1996 | 5,773,020 | ⤷ Try a Trial |
| Mylan Speciality Lp | DUONEB | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 020950-001 | Mar 21, 2001 | 6,632,842 | ⤷ Try a Trial |
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 9,421,166 | ⤷ Try a Trial |
| Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | 4,421,762 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for MYLAN SPECIALITY LP Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 0423800 | ⤷ Try a Trial |
| Poland | 2377557 | ⤷ Try a Trial |
| Spain | 2567068 | ⤷ Try a Trial |
| Japan | 2006522672 | ⤷ Try a Trial |
| Taiwan | I407981 | ⤷ Try a Trial |
| Slovenia | 2311510 | ⤷ Try a Trial |
| Spain | 2792185 | ⤷ 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 |
|---|---|---|---|---|
| 0770388 | 09C0018 | France | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 |
| 0334429 | 97C0002 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
| 0136011 | 99C0003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
| 3141251 | SPC/GB20/075 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS: POLYETHYLENE GLYCOL 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 20171016 |
| 0809498 | SPC/GB10/012 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112 |
| 0398460 | 12/2004 | Austria | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
| 1280520 | C300722 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720 |
| >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.
