Dalfampridine Patent Expiration

Dalfampridine is Used for improving walking in patients with multiple sclerosis. It was first introduced by Merz Pharmaceuticals Llc A Sub Of Merz Therapeutics Gmbh in its drug Ampyra on Jan 22, 2010. 9 different companies have introduced drugs containing Dalfampridine.


Dalfampridine Patents

Given below is the list of patents protecting Dalfampridine, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Ampyra US8007826 Sustained release aminopyridine composition May 26, 2027 Merz Pharms
Ampyra US8354437 Method of using sustained release aminopyridine compositions Dec 22, 2026 Merz Pharms
Ampyra US8440703 Methods of using sustained release aminopyridine compositions Apr 08, 2025 Merz Pharms
Ampyra US8663685 Sustained release aminopyridine composition Jan 18, 2025 Merz Pharms
Ampyra US9918973 Sustained release aminopyridine composition Dec 13, 2024

(Expired)

Merz Pharms
Ampyra US5540938 Formulations and their use in the treatment of neurological diseases Jul 30, 2018

(Expired)

Merz Pharms



Dalfampridine's Family Patents

Family Patents

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Dalfampridine Generic API Manufacturers

Several generic applications have been filed for Dalfampridine. The first generic version for Dalfampridine was by Actavis Laboratories Fl Inc and was approved on Jan 23, 2017. And the latest generic version is by Rising Pharma Holding Inc and was approved on Jul 6, 2020.

Given below is the list of companies who have filed for Dalfampridine generic, along with the locations of their manufacturing plants worldwide.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Dalfampridine. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet, extended release Prescription ORAL AB Jul 11, 2018





2. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 1 generic for Dalfampridine. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet, extended release Prescription ORAL AB Jan 23, 2017





3. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 1 generic for Dalfampridine. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet, extended release Prescription ORAL AB Jul 30, 2018





4. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Dalfampridine. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet, extended release Prescription ORAL AB Jan 23, 2017


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
United States
East Windsor Aurobindo Pharma USA Inc





5. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Dalfampridine. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet, extended release Discontinued ORAL N/A Oct 24, 2018


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





6. MICRO LABS

Micro Labs Ltd has filed for 1 generic for Dalfampridine. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet, extended release Prescription ORAL AB Mar 11, 2019


Manufacturing Plant Locations
New

Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.

Country City Firm Name
India
Verna Micro Labs Limited
Bengaluru Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Bangalore Micro Labs Limited





7. RISING

Rising Pharma Holding Inc has filed for 1 generic for Dalfampridine. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet, extended release Discontinued ORAL N/A Jul 6, 2020


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Phoenix Rising Sun Farms Inc
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





8. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Dalfampridine. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet, extended release Prescription ORAL AB May 21, 2019


Manufacturing Plant Locations
New

Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.

Country City Firm Name
United States
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
Dadra Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
New Delhi Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd.
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Halol Sun Pharmaceutical Industries Ltd.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd